NCT03881488 · OUTCOME

Half-life (t1/2) of Serum Concentration of CTX-471

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: GEOMETRIC_MEAN
Unit: hours
Interval / dispersion: Geometric Coefficient of Variation
Time frame: Calculated from plasma concentrations measured from samples collected before the first dose of CTX-471; 1, 6, and 24 hours after the first dose of CTX-471; and before the second dose of CTX-471 (Weeks 1 to 3)

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	11
CTX-471 Monotherapy 0.6 mg/kg	12
CTX-471 Monotherapy 1.2 mg/kg	3
CTX-471 Combination 0.1 mg/kg	2
CTX-471 Combination 0.3 mg/kg	3
CTX-471 Combination 0.6 mg/kg	4

Reported measurements

Source class 1

Values in hours · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
CTX-471 Monotherapy 0.1 mg/kg	147.9	9.1	Not reported	Not reported	Not reported
CTX-471 Monotherapy 0.3 mg/kg	163.6	27.8	Not reported	Not reported	Not reported
CTX-471 Monotherapy 0.6 mg/kg	159.2	24.4	Not reported	Not reported	Not reported
CTX-471 Monotherapy 1.2 mg/kg	156.6	19.9	Not reported	Not reported	Not reported
CTX-471 Combination 0.1 mg/kg	126.9	35.6	Not reported	Not reported	Not reported
CTX-471 Combination 0.3 mg/kg	145.3	30.5	Not reported	Not reported	Not reported
CTX-471 Combination 0.6 mg/kg	167.8	16.3	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
9.1
value
147.9
group Id
OG001
spread
27.8
value
163.6
group Id
OG002
spread
24.4
value
159.2
group Id
OG003
spread
19.9
value
156.6
group Id
OG004
spread
35.6
value
126.9
group Id
OG005
spread
30.5
value
145.3
group Id
OG006
spread
16.3
value
167.8

denoms

counts
group Id
OG000
value
3
group Id
OG001
value
11
group Id
OG002
value
12
group Id
OG003
value
3
group Id
OG004
value
2
group Id
OG005
value
3
group Id
OG006
value
4
units
Participants

dispersion Type

Geometric Coefficient of Variation

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

GEOMETRIC_MEAN

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

Calculated from plasma concentrations measured from samples collected before the first dose of CTX-471; 1, 6, and 24 hours after the first dose of CTX-471; and before the second dose of CTX-471 (Weeks 1 to 3)

title

Half-life (t1/2) of Serum Concentration of CTX-471

type

SECONDARY

unit Of Measure

hours

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

Preserved source evidence · Not medical advice