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NCT04306900 · OUTCOME

Confirmed Objective Response Rate (ORR)

TTX-030 in Combination With Immunotherapy and/or Chemotherapy in Subjects With Advanced Cancers · Source last updated 2025-07-29

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Through study completion, an average of 1 year

What was measured

ORR is defined as the proportion of subjects with CR or PR.

Analysis population: The ORR was defined as the proportion of participants who achieved a BOR of either CR or PR as derived based on the lesion measurement provided by the Investigator per RECIST v1.1. Confirmed ORR was defined as 2 disease response assessments showing objective response (CR or PR) at least 4 weeks apart and was presented with corresponding 2-sided 95% confidence intervals (CIs) based on the Clopper-Pearson method.

Groups in this outcome

Cohort 1 - Safety Lead-in (TTX-030 + Budigalimab + mFOLFOX6)

Participants in Cohort 1 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.

Cohort 3B - Gastric (TTX-030 + Budigalimab + mFOLFOX6)

Participants in Cohort 3B were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.

Cohort 12 - Gastric (Budigalimab + mFOLFOX6)

Participants in Cohort 12 were administered IV budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.

Cohort 3A - Gastric (TTX-030 + mFOLFOX6)

Participants in Cohort 3A were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.

Cohort 2 - mCRPC (TTX-030 + Budigalimab + Docetaxel)

Participants in Safety Lead-in Cohort 2 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab 375mg Q3W plus docetaxel at a dose of 75 mg/m2 Q3W on Day 1 of each 21-day treatment cycle.

Cohort 9 - Pancreatic (TTX-030 + Budigalimab + Gemcitabine + Nab-Paclitaxel)

Participants in Cohort 9 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.

Cohort 11 - Pancreatic (TTX-030 + Gemcitabine + Nab-Paclitaxel)

Participants in Cohort 11 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.

Cohort 4 - CRC (TTX-030 + Budigalimab)

Participants in Cohort 4 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.

Cohort 6 - HNSCC (TTX-030 + Budigalimab)

Participants in Cohort 6 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.

Cohort 8 - GEC (TTX-030 + Budigalimab)

Participants in Cohort 8 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.

Cohort 10 - UCC (TTX-030 + Pembrolizumab)

Participants in Cohort 10 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus pembrolizumab at a dose of 200 mg Q3W on Day 1 of each 21-day treatment cycle.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Cohort 1 - Safety Lead-in (TTX-030 + Budigalimab + mFOLFOX6)7
Cohort 3B - Gastric (TTX-030 + Budigalimab + mFOLFOX6)41
Cohort 12 - Gastric (Budigalimab + mFOLFOX6)23
Cohort 3A - Gastric (TTX-030 + mFOLFOX6)4
Cohort 2 - mCRPC (TTX-030 + Budigalimab + Docetaxel)3
Cohort 9 - Pancreatic (TTX-030 + Budigalimab + Gemcitabine + Nab-Paclitaxel)27
Cohort 11 - Pancreatic (TTX-030 + Gemcitabine + Nab-Paclitaxel)17
Cohort 4 - CRC (TTX-030 + Budigalimab)12
Cohort 6 - HNSCC (TTX-030 + Budigalimab)5
Cohort 8 - GEC (TTX-030 + Budigalimab)22
Cohort 10 - UCC (TTX-030 + Pembrolizumab)8

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort 1 - Safety Lead-in (TTX-030 + Budigalimab + mFOLFOX6)14.3Not reported0.457.9Not reported
Cohort 3B - Gastric (TTX-030 + Budigalimab + mFOLFOX6)56.1Not reported39.771.5Not reported
Cohort 12 - Gastric (Budigalimab + mFOLFOX6)69.6Not reported47.186.8Not reported
Cohort 3A - Gastric (TTX-030 + mFOLFOX6)75.0Not reported19.499.4Not reported
Cohort 2 - mCRPC (TTX-030 + Budigalimab + Docetaxel)0Not reported0.041.0Not reported
Cohort 9 - Pancreatic (TTX-030 + Budigalimab + Gemcitabine + Nab-Paclitaxel)33.3Not reported16.554.0Not reported
Cohort 11 - Pancreatic (TTX-030 + Gemcitabine + Nab-Paclitaxel)23.5Not reported6.849.9Not reported
Cohort 4 - CRC (TTX-030 + Budigalimab)0.0Not reported0.026.5Not reported
Cohort 6 - HNSCC (TTX-030 + Budigalimab)0.0Not reported0.052.2Not reported
Cohort 8 - GEC (TTX-030 + Budigalimab)9.1Not reported1.129.2Not reported
Cohort 10 - UCC (TTX-030 + Pembrolizumab)12.5Not reported0.352.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.4
        upper Limit
        57.9
        value
        14.3
      2. group Id
        OG001
        lower Limit
        39.7
        upper Limit
        71.5
        value
        56.1
      3. group Id
        OG002
        lower Limit
        47.1
        upper Limit
        86.8
        value
        69.6
      4. group Id
        OG003
        lower Limit
        19.4
        upper Limit
        99.4
        value
        75.0
      5. group Id
        OG004
        lower Limit
        0.0
        upper Limit
        41.0
        value
        0
      6. group Id
        OG005
        lower Limit
        16.5
        upper Limit
        54.0
        value
        33.3
      7. group Id
        OG006
        lower Limit
        6.8
        upper Limit
        49.9
        value
        23.5
      8. group Id
        OG007
        lower Limit
        0.0
        upper Limit
        26.5
        value
        0.0
      9. group Id
        OG008
        lower Limit
        0.0
        upper Limit
        52.2
        value
        0.0
      10. group Id
        OG009
        lower Limit
        1.1
        upper Limit
        29.2
        value
        9.1
      11. group Id
        OG010
        lower Limit
        0.3
        upper Limit
        52.7
        value
        12.5
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      41
    3. group Id
      OG002
      value
      23
    4. group Id
      OG003
      value
      4
    5. group Id
      OG004
      value
      3
    6. group Id
      OG005
      value
      27
    7. group Id
      OG006
      value
      17
    8. group Id
      OG007
      value
      12
    9. group Id
      OG008
      value
      5
    10. group Id
      OG009
      value
      22
    11. group Id
      OG010
      value
      8
    units
    Participants
description
ORR is defined as the proportion of subjects with CR or PR.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants in Cohort 1 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
    id
    OG000
    title
    Cohort 1 - Safety Lead-in (TTX-030 + Budigalimab + mFOLFOX6)
  2. description
    Participants in Cohort 3B were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
    id
    OG001
    title
    Cohort 3B - Gastric (TTX-030 + Budigalimab + mFOLFOX6)
  3. description
    Participants in Cohort 12 were administered IV budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
    id
    OG002
    title
    Cohort 12 - Gastric (Budigalimab + mFOLFOX6)
  4. description
    Participants in Cohort 3A were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
    id
    OG003
    title
    Cohort 3A - Gastric (TTX-030 + mFOLFOX6)
  5. description
    Participants in Safety Lead-in Cohort 2 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab 375mg Q3W plus docetaxel at a dose of 75 mg/m2 Q3W on Day 1 of each 21-day treatment cycle.
    id
    OG004
    title
    Cohort 2 - mCRPC (TTX-030 + Budigalimab + Docetaxel)
  6. description
    Participants in Cohort 9 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
    id
    OG005
    title
    Cohort 9 - Pancreatic (TTX-030 + Budigalimab + Gemcitabine + Nab-Paclitaxel)
  7. description
    Participants in Cohort 11 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
    id
    OG006
    title
    Cohort 11 - Pancreatic (TTX-030 + Gemcitabine + Nab-Paclitaxel)
  8. description
    Participants in Cohort 4 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
    id
    OG007
    title
    Cohort 4 - CRC (TTX-030 + Budigalimab)
  9. description
    Participants in Cohort 6 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
    id
    OG008
    title
    Cohort 6 - HNSCC (TTX-030 + Budigalimab)
  10. description
    Participants in Cohort 8 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
    id
    OG009
    title
    Cohort 8 - GEC (TTX-030 + Budigalimab)
  11. description
    Participants in Cohort 10 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus pembrolizumab at a dose of 200 mg Q3W on Day 1 of each 21-day treatment cycle.
    id
    OG010
    title
    Cohort 10 - UCC (TTX-030 + Pembrolizumab)
param Type
NUMBER
population Description
The ORR was defined as the proportion of participants who achieved a BOR of either CR or PR as derived based on the lesion measurement provided by the Investigator per RECIST v1.1. Confirmed ORR was defined as 2 disease response assessments showing objective response (CR or PR) at least 4 weeks apart and was presented with corresponding 2-sided 95% confidence intervals (CIs) based on the Clopper-Pearson method.
reporting Status
POSTED
time Frame
Through study completion, an average of 1 year
title
Confirmed Objective Response Rate (ORR)
type
SECONDARY
unit Of Measure
percentage of participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice