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NCT03881488 · OUTCOME

Development of Anti-drug Antibodies

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: Monotherapy arms: Weeks 3, 5, 9, 13, 17, 21, 25, 29, 33, and 37 and end of treatment and 60 days after end of treatment; Combination therapy arms: Weeks 5, 9, 13, 19, 25, 31, and 37 and end of treatment and 60 days after end of treatment

What was measured

Frequency of patients with a negative test result for antibody to CTX-471 prior to treatment who had a positive test for antibody to CTX-471 after treatment. For monotherapy arms, end of treatment was an average 18 weeks, and 60 days after end of treatment was an average 27 weeks. For combination arms, end of treatment was an average 15 weeks, and 60 days after end of treatment was an average 24 weeks.

Analysis population: Pharmacokinetic Analysis Set: all patients who received CTX-471 (and pembrolizumab in combination arms) and had at least 1 post-treatment measurement and no protocol deviations or events affecting the validity of the 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	14
CTX-471 Monotherapy 0.6 mg/kg	17
CTX-471 Monotherapy 1.2 mg/kg	7
CTX-471 Combination 0.1 mg/kg	3
CTX-471 Combination 0.3 mg/kg	3
CTX-471 Combination 0.6 mg/kg	7

Reported measurements

Week 3

Analysis denominator · Participants

Group	Source count
CTX-471 Monotherapy 0.1 mg/kg	3
CTX-471 Monotherapy 0.3 mg/kg	14
CTX-471 Monotherapy 0.6 mg/kg	17
CTX-471 Monotherapy 1.2 mg/kg	7
CTX-471 Combination 0.1 mg/kg	0
CTX-471 Combination 0.3 mg/kg	0
CTX-471 Combination 0.6 mg/kg	0

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	1	Not reported	Not reported	Not reported	Not reported

Week 5

Analysis denominator · Participants

Group	Source count
CTX-471 Monotherapy 0.1 mg/kg	3
CTX-471 Monotherapy 0.3 mg/kg	14
CTX-471 Monotherapy 0.6 mg/kg	17
CTX-471 Monotherapy 1.2 mg/kg	7
CTX-471 Combination 0.1 mg/kg	3
CTX-471 Combination 0.3 mg/kg	3
CTX-471 Combination 0.6 mg/kg	7

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	0	Not reported	Not reported	Not reported	Not reported

Week 9

Analysis denominator · Participants

Group	Source count
CTX-471 Monotherapy 0.1 mg/kg	3
CTX-471 Monotherapy 0.3 mg/kg	14
CTX-471 Monotherapy 0.6 mg/kg	17
CTX-471 Monotherapy 1.2 mg/kg	7
CTX-471 Combination 0.1 mg/kg	3
CTX-471 Combination 0.3 mg/kg	3
CTX-471 Combination 0.6 mg/kg	7

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	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

Week 13

Analysis denominator · Participants

Group	Source count
CTX-471 Monotherapy 0.1 mg/kg	3
CTX-471 Monotherapy 0.3 mg/kg	14
CTX-471 Monotherapy 0.6 mg/kg	17
CTX-471 Monotherapy 1.2 mg/kg	7
CTX-471 Combination 0.1 mg/kg	3
CTX-471 Combination 0.3 mg/kg	3
CTX-471 Combination 0.6 mg/kg	7

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CTX-471 Monotherapy 0.1 mg/kg	2	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	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

Week 17

Analysis denominator · Participants

Group	Source count
CTX-471 Monotherapy 0.1 mg/kg	3
CTX-471 Monotherapy 0.3 mg/kg	14
CTX-471 Monotherapy 0.6 mg/kg	17
CTX-471 Monotherapy 1.2 mg/kg	7
CTX-471 Combination 0.1 mg/kg	0
CTX-471 Combination 0.3 mg/kg	0
CTX-471 Combination 0.6 mg/kg	0

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

Week 19

Analysis denominator · Participants

Group	Source count
CTX-471 Monotherapy 0.1 mg/kg	0
CTX-471 Monotherapy 0.3 mg/kg	0
CTX-471 Monotherapy 0.6 mg/kg	0
CTX-471 Monotherapy 1.2 mg/kg	0
CTX-471 Combination 0.1 mg/kg	3
CTX-471 Combination 0.3 mg/kg	3
CTX-471 Combination 0.6 mg/kg	7

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
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

Week 21

Analysis denominator · Participants

Group	Source count
CTX-471 Monotherapy 0.1 mg/kg	3
CTX-471 Monotherapy 0.3 mg/kg	14
CTX-471 Monotherapy 0.6 mg/kg	17
CTX-471 Monotherapy 1.2 mg/kg	7
CTX-471 Combination 0.1 mg/kg	0
CTX-471 Combination 0.3 mg/kg	0
CTX-471 Combination 0.6 mg/kg	0

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

Week 25

Analysis denominator · Participants

Group	Source count
CTX-471 Monotherapy 0.1 mg/kg	3
CTX-471 Monotherapy 0.3 mg/kg	14
CTX-471 Monotherapy 0.6 mg/kg	17
CTX-471 Monotherapy 1.2 mg/kg	7
CTX-471 Combination 0.1 mg/kg	3
CTX-471 Combination 0.3 mg/kg	3
CTX-471 Combination 0.6 mg/kg	7

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

Week 29

Analysis denominator · Participants

Group	Source count
CTX-471 Monotherapy 0.1 mg/kg	3
CTX-471 Monotherapy 0.3 mg/kg	14
CTX-471 Monotherapy 0.6 mg/kg	17
CTX-471 Monotherapy 1.2 mg/kg	7
CTX-471 Combination 0.1 mg/kg	0
CTX-471 Combination 0.3 mg/kg	0
CTX-471 Combination 0.6 mg/kg	0

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

Week 31

Analysis denominator · Participants

Group	Source count
CTX-471 Monotherapy 0.1 mg/kg	0
CTX-471 Monotherapy 0.3 mg/kg	0
CTX-471 Monotherapy 0.6 mg/kg	0
CTX-471 Monotherapy 1.2 mg/kg	0
CTX-471 Combination 0.1 mg/kg	3
CTX-471 Combination 0.3 mg/kg	3
CTX-471 Combination 0.6 mg/kg	7

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
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

Week 33

Analysis denominator · Participants

Group	Source count
CTX-471 Monotherapy 0.1 mg/kg	3
CTX-471 Monotherapy 0.3 mg/kg	14
CTX-471 Monotherapy 0.6 mg/kg	17
CTX-471 Monotherapy 1.2 mg/kg	7
CTX-471 Combination 0.1 mg/kg	0
CTX-471 Combination 0.3 mg/kg	0
CTX-471 Combination 0.6 mg/kg	0

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

Week 37

Analysis denominator · Participants

Group	Source count
CTX-471 Monotherapy 0.1 mg/kg	3
CTX-471 Monotherapy 0.3 mg/kg	14
CTX-471 Monotherapy 0.6 mg/kg	17
CTX-471 Monotherapy 1.2 mg/kg	7
CTX-471 Combination 0.1 mg/kg	3
CTX-471 Combination 0.3 mg/kg	3
CTX-471 Combination 0.6 mg/kg	7

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	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

End of Treatment

Analysis denominator · Participants

Group	Source count
CTX-471 Monotherapy 0.1 mg/kg	3
CTX-471 Monotherapy 0.3 mg/kg	14
CTX-471 Monotherapy 0.6 mg/kg	17
CTX-471 Monotherapy 1.2 mg/kg	7
CTX-471 Combination 0.1 mg/kg	3
CTX-471 Combination 0.3 mg/kg	3
CTX-471 Combination 0.6 mg/kg	7

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	2	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	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

60 days after end of treatment

Analysis denominator · Participants

Group	Source count
CTX-471 Monotherapy 0.1 mg/kg	3
CTX-471 Monotherapy 0.3 mg/kg	14
CTX-471 Monotherapy 0.6 mg/kg	17
CTX-471 Monotherapy 1.2 mg/kg	7
CTX-471 Combination 0.1 mg/kg	3
CTX-471 Combination 0.3 mg/kg	3
CTX-471 Combination 0.6 mg/kg	7

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

Complete source fields

calculate Pct

false

classes

categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
1
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
14
group Id
OG002
value
17
group Id
OG003
value
7
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
units
Participants
title
Week 3
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
14
group Id
OG002
value
17
group Id
OG003
value
7
group Id
OG004
value
3
group Id
OG005
value
3
group Id
OG006
value
7
units
Participants
title
Week 5
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
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
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
14
group Id
OG002
value
17
group Id
OG003
value
7
group Id
OG004
value
3
group Id
OG005
value
3
group Id
OG006
value
7
units
Participants
title
Week 9
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
0
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
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
14
group Id
OG002
value
17
group Id
OG003
value
7
group Id
OG004
value
3
group Id
OG005
value
3
group Id
OG006
value
7
units
Participants
title
Week 13
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
1
group Id
OG003
value
0
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
14
group Id
OG002
value
17
group Id
OG003
value
7
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
units
Participants
title
Week 17
categories
measurements
group Id
OG004
value
0
group Id
OG005
value
1
group Id
OG006
value
0
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
3
group Id
OG005
value
3
group Id
OG006
value
7
units
Participants
title
Week 19
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
2
group Id
OG002
value
1
group Id
OG003
value
0
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
14
group Id
OG002
value
17
group Id
OG003
value
7
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
units
Participants
title
Week 21
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
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
14
group Id
OG002
value
17
group Id
OG003
value
7
group Id
OG004
value
3
group Id
OG005
value
3
group Id
OG006
value
7
units
Participants
title
Week 25
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
0
group Id
OG003
value
0
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
14
group Id
OG002
value
17
group Id
OG003
value
7
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
units
Participants
title
Week 29
categories
measurements
group Id
OG004
value
0
group Id
OG005
value
1
group Id
OG006
value
0
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
3
group Id
OG005
value
3
group Id
OG006
value
7
units
Participants
title
Week 31
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
0
group Id
OG003
value
0
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
14
group Id
OG002
value
17
group Id
OG003
value
7
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
units
Participants
title
Week 33
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
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
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
14
group Id
OG002
value
17
group Id
OG003
value
7
group Id
OG004
value
3
group Id
OG005
value
3
group Id
OG006
value
7
units
Participants
title
Week 37

denoms

counts
group Id
OG000
value
3
group Id
OG001
value
14
group Id
OG002
value
17
group Id
OG003
value
7
group Id
OG004
value
3
group Id
OG005
value
3
group Id
OG006
value
7
units
Participants

description

Frequency of patients with a negative test result for antibody to CTX-471 prior to treatment who had a positive test for antibody to CTX-471 after treatment. For monotherapy arms, end of treatment was an average 18 weeks, and 60 days after end of treatment was an average 27 weeks. For combination arms, end of treatment was an average 15 weeks, and 60 days after end of treatment was an average 24 weeks.

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

population Description

Pharmacokinetic Analysis Set: all patients who received CTX-471 (and pembrolizumab in combination arms) and had at least 1 post-treatment measurement and no protocol deviations or events affecting the validity of the results

reporting Status

POSTED

time Frame

Monotherapy arms: Weeks 3, 5, 9, 13, 17, 21, 25, 29, 33, and 37 and end of treatment and 60 days after end of treatment; Combination therapy arms: Weeks 5, 9, 13, 19, 25, 31, and 37 and end of treatment and 60 days after end of treatment

title

Development of Anti-drug Antibodies

type

SECONDARY

unit Of Measure

Participants

Download exact source JSON → · Snapshot ctgov-results-d643ffaf417bcef6d45eb5e0

Preserved source evidence · Not medical advice