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NCT03881488 · OUTCOME

Overall Response Rate

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 the first dose of CTX-471 to treatment discontinuation (average of 18 weeks for monotherapy groups and and average of 15 weeks for combination groups)

What was measured

Percentage of patients whose best overall response to treatment was complete response or partial response (as assessed by Response Evaluation Criteria in Solid Tumours guideline version 1.1)

Analysis population: Response Evaluable Analysis Set: all patients with measurable disease before treatment who received CTX-471 (and pembrolizumab in combination arms) and had at least 1 post-treatment response assessment or discontinued treatment due to progression of disease progression within 8 weeks after first dose of study treatment

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

GroupSource count
CTX-471 Monotherapy 0.1 mg/kg3
CTX-471 Monotherapy 0.3 mg/kg31
CTX-471 Monotherapy 0.6 mg/kg32
CTX-471 Monotherapy 1.2 mg/kg7
CTX-471 Combination 0.1 mg/kg3
CTX-471 Combination 0.3 mg/kg8
CTX-471 Combination 0.6 mg/kg9

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CTX-471 Monotherapy 0.1 mg/kg0Not reportedNot reportedNot reportedNot reported
CTX-471 Monotherapy 0.3 mg/kg4Not reportedNot reportedNot reportedNot reported
CTX-471 Monotherapy 0.6 mg/kg1Not reportedNot reportedNot reportedNot reported
CTX-471 Monotherapy 1.2 mg/kg0Not reportedNot reportedNot reportedNot reported
CTX-471 Combination 0.1 mg/kg0Not reportedNot reportedNot reportedNot reported
CTX-471 Combination 0.3 mg/kg0Not reportedNot reportedNot reportedNot reported
CTX-471 Combination 0.6 mg/kg0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      31
    3. group Id
      OG002
      value
      32
    4. group Id
      OG003
      value
      7
    5. group Id
      OG004
      value
      3
    6. group Id
      OG005
      value
      8
    7. group Id
      OG006
      value
      9
    units
    Participants
description
Percentage of patients whose best overall response to treatment was complete response or partial response (as assessed by Response Evaluation Criteria in Solid Tumours guideline version 1.1)
groups
  1. 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
  2. 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
  3. 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
  4. 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
  5. 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
  6. 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
  7. 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
Response Evaluable Analysis Set: all patients with measurable disease before treatment who received CTX-471 (and pembrolizumab in combination arms) and had at least 1 post-treatment response assessment or discontinued treatment due to progression of disease progression within 8 weeks after first dose of study treatment
reporting Status
POSTED
time Frame
From the first dose of CTX-471 to treatment discontinuation (average of 18 weeks for monotherapy groups and and average of 15 weeks for combination groups)
title
Overall Response Rate
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice