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NCT04306900 · OUTCOME

Duration of Response (DOR)

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

DoR will be defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.

Analysis population: Number (%) of subjects with events (PFS)

Groups in this outcome

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 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 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 3B - Gastric (TTX-030 + Budigalimab + mFOLFOX6)23
Cohort 12 - Gastric (Budigalimab + mFOLFOX6)16
Cohort 3A - Gastric (TTX-030 + mFOLFOX6)3
Cohort 9 - Pancreatic (TTX-030 + Budigalimab + Gemcitabine + Nab-Paclitaxel)9
Cohort 11 - Pancreatic (TTX-030 + Gemcitabine + Nab-Paclitaxel)4
Cohort 8 - GEC (TTX-030 + Budigalimab)2
Cohort 10 - UCC (TTX-030 + Pembrolizumab)1

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 3B - Gastric (TTX-030 + Budigalimab + mFOLFOX6)13Not reportedNot reportedNot reportedNot reported
Cohort 12 - Gastric (Budigalimab + mFOLFOX6)4Not reportedNot reportedNot reportedNot reported
Cohort 3A - Gastric (TTX-030 + mFOLFOX6)3Not reportedNot reportedNot reportedNot reported
Cohort 9 - Pancreatic (TTX-030 + Budigalimab + Gemcitabine + Nab-Paclitaxel)4Not reportedNot reportedNot reportedNot reported
Cohort 11 - Pancreatic (TTX-030 + Gemcitabine + Nab-Paclitaxel)4Not reportedNot reportedNot reportedNot reported
Cohort 8 - GEC (TTX-030 + Budigalimab)1Not reportedNot reportedNot reportedNot reported
Cohort 10 - UCC (TTX-030 + Pembrolizumab)0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        4
      5. group Id
        OG004
        value
        4
      6. group Id
        OG005
        value
        1
      7. group Id
        OG006
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      23
    2. group Id
      OG001
      value
      16
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      9
    5. group Id
      OG004
      value
      4
    6. group Id
      OG005
      value
      2
    7. group Id
      OG006
      value
      1
    units
    Participants
description
DoR will be defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.
groups
  1. 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
    OG000
    title
    Cohort 3B - Gastric (TTX-030 + Budigalimab + mFOLFOX6)
  2. 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
    OG001
    title
    Cohort 12 - Gastric (Budigalimab + mFOLFOX6)
  3. 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
    OG002
    title
    Cohort 3A - Gastric (TTX-030 + mFOLFOX6)
  4. 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
    OG003
    title
    Cohort 9 - Pancreatic (TTX-030 + Budigalimab + Gemcitabine + Nab-Paclitaxel)
  5. 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
    OG004
    title
    Cohort 11 - Pancreatic (TTX-030 + Gemcitabine + Nab-Paclitaxel)
  6. 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
    OG005
    title
    Cohort 8 - GEC (TTX-030 + Budigalimab)
  7. 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
    OG006
    title
    Cohort 10 - UCC (TTX-030 + Pembrolizumab)
param Type
COUNT_OF_PARTICIPANTS
population Description
Number (%) of subjects with events (PFS)
reporting Status
POSTED
time Frame
Through study completion, an average of 1 year
title
Duration of Response (DOR)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice