Number of Participants With Dose Limiting Toxicities (DLTs), Treatment-emergent Adverse Events (TEAEs), and/or Changes in Clinical Laboratory Abnormalities
Study of CTX-471 as a Monotherapy or in Combination With Pembrolizumab in Patients Post PD-1/PD-L1 Inhibitors in Metastatic or Locally Advanced Malignancies · Source last updated 2026-10-09
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From first CTX-471 dose to 4 weeks after first dose for DLTs in monotherapy arms, to 6 weeks after first dose for DLTs in combination arms, to 60 days after last dose for TEAEs and clinical laboratory abnormalities in both monotherapy and combination arms
What was measured
Hematological and nonhematological DLTs were defined in the protocol. TEAE is an occurrence of an adverse event that started or worsened in severity on or after the first dose of CTX-471. Change in clinical laboratory abnormalities is defined as a TEAE related to laboratory results.
Groups in this outcome
CTX-471 Monotherapy 0.1 mg/kg
0.1 mg/kg body weight of CTX-471 by IV infusion over 1 hour every 2 weeks
CTX-471 Monotherapy 0.3 mg/kg
0.3 mg/kg body weight of CTX-471 by IV infusion over 1 hour every 2 weeks
CTX-471 Monotherapy 0.6 mg/kg
0.6 mg/kg body weight of CTX-471 by IV infusion over 1 hour every 2 weeks
CTX-471 Monotherapy 1.2 mg/kg
1.2 mg/kg body weight of CTX-471 by IV infusion over 1 hour every 2 weeks
CTX-471 Combination 0.1 mg/kg
0.1 mg/kg body weight of CTX-471 by IV infusion over 1 hour every 2 weeks + 400 mg of pembrolizumab by IV infusion over 30 minutes every 6 weeks
CTX-471 Combination 0.3 mg/kg
0.3 mg/kg body weight of CTX-471 by IV infusion over 1 hour every 2 weeks + 400 mg of pembrolizumab by IV infusion over 30 minutes every 6 weeks
CTX-471 Combination 0.6 mg/kg
0.6 mg/kg body weight of CTX-471 by IV infusion over 1 hour every 2 weeks + 400 mg of pembrolizumab by IV infusion over 30 minutes every 6 weeks
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group
Source count
CTX-471 Monotherapy 0.1 mg/kg
3
CTX-471 Monotherapy 0.3 mg/kg
33
CTX-471 Monotherapy 0.6 mg/kg
36
CTX-471 Monotherapy 1.2 mg/kg
7
CTX-471 Combination 0.1 mg/kg
3
CTX-471 Combination 0.3 mg/kg
9
CTX-471 Combination 0.6 mg/kg
9
Reported measurements
Dose-limiting toxicity
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
CTX-471 Monotherapy 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.3 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.6 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 1.2 mg/kg
2
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.3 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.6 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Treatment-emergent adverse event
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
CTX-471 Monotherapy 0.1 mg/kg
1
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.3 mg/kg
33
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.6 mg/kg
36
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 1.2 mg/kg
7
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.1 mg/kg
3
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.3 mg/kg
8
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.6 mg/kg
9
Not reported
Not reported
Not reported
Not reported
Blood creatinine increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
CTX-471 Monotherapy 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.3 mg/kg
7
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.6 mg/kg
4
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 1.2 mg/kg
1
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.1 mg/kg
1
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.3 mg/kg
1
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.6 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Alanine aminotransferase increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
CTX-471 Monotherapy 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.3 mg/kg
3
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.6 mg/kg
3
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 1.2 mg/kg
2
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.3 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.6 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Aspartate aminotransferase increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
CTX-471 Monotherapy 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.3 mg/kg
2
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.6 mg/kg
5
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 1.2 mg/kg
1
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.3 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.6 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Blood alkaline phosphatase increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
CTX-471 Monotherapy 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.3 mg/kg
4
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.6 mg/kg
3
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 1.2 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.3 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.6 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Lipase increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
CTX-471 Monotherapy 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.3 mg/kg
2
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.6 mg/kg
3
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 1.2 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.1 mg/kg
1
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.3 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.6 mg/kg
1
Not reported
Not reported
Not reported
Not reported
Amylase increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
CTX-471 Monotherapy 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.3 mg/kg
1
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.6 mg/kg
3
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 1.2 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.1 mg/kg
1
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.3 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.6 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Platelet count decreased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
CTX-471 Monotherapy 0.1 mg/kg
1
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.3 mg/kg
1
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.6 mg/kg
1
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 1.2 mg/kg
1
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.3 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.6 mg/kg
0
Not reported
Not reported
Not reported
Not reported
International normalised ratio increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
CTX-471 Monotherapy 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.3 mg/kg
2
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.6 mg/kg
1
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 1.2 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.3 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.6 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Lymphocyte count decreased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
CTX-471 Monotherapy 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.3 mg/kg
2
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.6 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 1.2 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.3 mg/kg
1
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.6 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Transaminases increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
CTX-471 Monotherapy 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.3 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.6 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 1.2 mg/kg
1
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.3 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.6 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Activated partial thromboplastin time prolonged
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
CTX-471 Monotherapy 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.3 mg/kg
1
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.6 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 1.2 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.3 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.6 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Bilirubin conjugated increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
CTX-471 Monotherapy 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.3 mg/kg
1
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.6 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 1.2 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.3 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.6 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Blood bilirubin increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
CTX-471 Monotherapy 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.3 mg/kg
1
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.6 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 1.2 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.3 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.6 mg/kg
1
Not reported
Not reported
Not reported
Not reported
Blood lactate dehydrogenase increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
CTX-471 Monotherapy 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.3 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.6 mg/kg
1
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 1.2 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.3 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.6 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Blood lactic acid increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
CTX-471 Monotherapy 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.3 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.6 mg/kg
1
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 1.2 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.3 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.6 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Blood phosphorus decreased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
CTX-471 Monotherapy 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.3 mg/kg
1
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.6 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 1.2 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.3 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.6 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Blood thyroid stimulating hormone decreased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
CTX-471 Monotherapy 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.3 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.6 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 1.2 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.3 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.6 mg/kg
1
Not reported
Not reported
Not reported
Not reported
Carbon dioxide decreased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
CTX-471 Monotherapy 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.3 mg/kg
1
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.6 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 1.2 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.3 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.6 mg/kg
1
Not reported
Not reported
Not reported
Not reported
Troponin increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
CTX-471 Monotherapy 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.3 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.6 mg/kg
1
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 1.2 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.3 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.6 mg/kg
0
Not reported
Not reported
Not reported
Not reported
White blood cell count decreased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
CTX-471 Monotherapy 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.3 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.6 mg/kg
1
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 1.2 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.3 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.6 mg/kg
1
Not reported
Not reported
Not reported
Not reported
White blood cell count increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
CTX-471 Monotherapy 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.3 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.6 mg/kg
1
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 1.2 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.3 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.6 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Hyponatraemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
CTX-471 Monotherapy 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.3 mg/kg
5
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.6 mg/kg
9
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 1.2 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.3 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.6 mg/kg
1
Not reported
Not reported
Not reported
Not reported
Hyperkalaemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
CTX-471 Monotherapy 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.3 mg/kg
2
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.6 mg/kg
2
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 1.2 mg/kg
1
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.3 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.6 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Hypomagnesaemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
CTX-471 Monotherapy 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.3 mg/kg
1
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.6 mg/kg
3
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 1.2 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.1 mg/kg
1
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.3 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.6 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Hypophosphataemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
CTX-471 Monotherapy 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.3 mg/kg
3
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.6 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 1.2 mg/kg
1
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.3 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.6 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Hypokalaemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
CTX-471 Monotherapy 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.3 mg/kg
2
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.6 mg/kg
1
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 1.2 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.1 mg/kg
1
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.3 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.6 mg/kg
2
Not reported
Not reported
Not reported
Not reported
Hyperphosphataemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
CTX-471 Monotherapy 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.3 mg/kg
2
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.6 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 1.2 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.3 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.6 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Hypoalbuminaemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
CTX-471 Monotherapy 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.3 mg/kg
1
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.6 mg/kg
1
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 1.2 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.3 mg/kg
1
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.6 mg/kg
1
Not reported
Not reported
Not reported
Not reported
Hypocalcaemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
CTX-471 Monotherapy 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.3 mg/kg
1
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.6 mg/kg
1
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 1.2 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.1 mg/kg
1
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.3 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.6 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Hypercalcaemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
CTX-471 Monotherapy 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.3 mg/kg
1
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.6 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 1.2 mg/kg
1
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.3 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.6 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Hyperglycaemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
CTX-471 Monotherapy 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.3 mg/kg
1
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.6 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 1.2 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.3 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.6 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Hypermagnesaemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
CTX-471 Monotherapy 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.3 mg/kg
1
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.6 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 1.2 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.3 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.6 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Hypernatraemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
CTX-471 Monotherapy 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.3 mg/kg
1
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.6 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 1.2 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.1 mg/kg
1
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.3 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.6 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Hypoglycaemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
CTX-471 Monotherapy 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.3 mg/kg
1
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.6 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 1.2 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.3 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.6 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Anaemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
CTX-471 Monotherapy 0.1 mg/kg
1
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.3 mg/kg
9
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.6 mg/kg
12
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 1.2 mg/kg
3
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.1 mg/kg
1
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.3 mg/kg
2
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.6 mg/kg
1
Not reported
Not reported
Not reported
Not reported
Neutropenia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
CTX-471 Monotherapy 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.3 mg/kg
1
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.6 mg/kg
1
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 1.2 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.3 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.6 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Thrombocytopenia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
CTX-471 Monotherapy 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.3 mg/kg
1
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 0.6 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Monotherapy 1.2 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.1 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.3 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CTX-471 Combination 0.6 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
2
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
title
Dose-limiting toxicity
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
33
group Id
OG002
value
36
group Id
OG003
value
7
group Id
OG004
value
3
group Id
OG005
value
8
group Id
OG006
value
9
title
Treatment-emergent adverse event
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
7
group Id
OG002
value
4
group Id
OG003
value
1
group Id
OG004
value
1
group Id
OG005
value
1
group Id
OG006
value
0
title
Blood creatinine increased
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
3
group Id
OG002
value
3
group Id
OG003
value
2
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
title
Alanine aminotransferase increased
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
2
group Id
OG002
value
5
group Id
OG003
value
1
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
title
Aspartate aminotransferase increased
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
4
group Id
OG002
value
3
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
title
Blood alkaline phosphatase increased
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
2
group Id
OG002
value
3
group Id
OG003
value
0
group Id
OG004
value
1
group Id
OG005
value
0
group Id
OG006
value
1
title
Lipase increased
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
3
group Id
OG003
value
0
group Id
OG004
value
1
group Id
OG005
value
0
group Id
OG006
value
0
title
Amylase increased
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
group Id
OG002
value
1
group Id
OG003
value
1
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
title
Platelet count decreased
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
2
group Id
OG002
value
1
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
title
International normalised ratio increased
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
2
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
1
group Id
OG006
value
0
title
Lymphocyte count decreased
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
1
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
title
Transaminases increased
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
33
group Id
OG002
value
36
group Id
OG003
value
7
group Id
OG004
value
3
group Id
OG005
value
9
group Id
OG006
value
9
units
Participants
description
Hematological and nonhematological DLTs were defined in the protocol. TEAE is an occurrence of an adverse event that started or worsened in severity on or after the first dose of CTX-471. Change in clinical laboratory abnormalities is defined as a TEAE related to laboratory results.
groups
description
0.1 mg/kg body weight of CTX-471 by IV infusion over 1 hour every 2 weeks
id
OG000
title
CTX-471 Monotherapy 0.1 mg/kg
description
0.3 mg/kg body weight of CTX-471 by IV infusion over 1 hour every 2 weeks
id
OG001
title
CTX-471 Monotherapy 0.3 mg/kg
description
0.6 mg/kg body weight of CTX-471 by IV infusion over 1 hour every 2 weeks
id
OG002
title
CTX-471 Monotherapy 0.6 mg/kg
description
1.2 mg/kg body weight of CTX-471 by IV infusion over 1 hour every 2 weeks
id
OG003
title
CTX-471 Monotherapy 1.2 mg/kg
description
0.1 mg/kg body weight of CTX-471 by IV infusion over 1 hour every 2 weeks + 400 mg of pembrolizumab by IV infusion over 30 minutes every 6 weeks
id
OG004
title
CTX-471 Combination 0.1 mg/kg
description
0.3 mg/kg body weight of CTX-471 by IV infusion over 1 hour every 2 weeks + 400 mg of pembrolizumab by IV infusion over 30 minutes every 6 weeks
id
OG005
title
CTX-471 Combination 0.3 mg/kg
description
0.6 mg/kg body weight of CTX-471 by IV infusion over 1 hour every 2 weeks + 400 mg of pembrolizumab by IV infusion over 30 minutes every 6 weeks
id
OG006
title
CTX-471 Combination 0.6 mg/kg
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
From first CTX-471 dose to 4 weeks after first dose for DLTs in monotherapy arms, to 6 weeks after first dose for DLTs in combination arms, to 60 days after last dose for TEAEs and clinical laboratory abnormalities in both monotherapy and combination arms
title
Number of Participants With Dose Limiting Toxicities (DLTs), Treatment-emergent Adverse Events (TEAEs), and/or Changes in Clinical Laboratory Abnormalities
Triangle