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NCT04306900 · OUTCOME

Disease Control Rate (DCR)

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Through study completion, an average of 1 year

What was measured

DCR is defined as the proportion of subjects with CR, PR, or SD per RECIST 1.1

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)7
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 Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1 - Safety Lead-in (TTX-030 + Budigalimab + mFOLFOX6)3Not reportedNot reportedNot reportedNot reported
Cohort 3B - Gastric (TTX-030 + Budigalimab + mFOLFOX6)37Not reportedNot reportedNot reportedNot reported
Cohort 12 - Gastric (Budigalimab + mFOLFOX6)22Not reportedNot reportedNot reportedNot reported
Cohort 3A - Gastric (TTX-030 + mFOLFOX6)3Not reportedNot reportedNot reportedNot reported
Cohort 2 - mCRPC (TTX-030 + Budigalimab + Docetaxel)2Not reportedNot reportedNot reportedNot reported
Cohort 9 - Pancreatic (TTX-030 + Budigalimab + Gemcitabine + Nab-Paclitaxel)22Not reportedNot reportedNot reportedNot reported
Cohort 11 - Pancreatic (TTX-030 + Gemcitabine + Nab-Paclitaxel)14Not reportedNot reportedNot reportedNot reported
Cohort 4 - CRC (TTX-030 + Budigalimab)3Not reportedNot reportedNot reportedNot reported
Cohort 6 - HNSCC (TTX-030 + Budigalimab)1Not reportedNot reportedNot reportedNot reported
Cohort 8 - GEC (TTX-030 + Budigalimab)7Not reportedNot reportedNot reportedNot reported
Cohort 10 - UCC (TTX-030 + Pembrolizumab)1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        37
      3. group Id
        OG002
        value
        22
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        2
      6. group Id
        OG005
        value
        22
      7. group Id
        OG006
        value
        14
      8. group Id
        OG007
        value
        3
      9. group Id
        OG008
        value
        1
      10. group Id
        OG009
        value
        7
      11. group Id
        OG010
        value
        1
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
      7
    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
DCR is defined as the proportion of subjects with CR, PR, or SD per RECIST 1.1
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
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Through study completion, an average of 1 year
title
Disease Control Rate (DCR)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice