NCT04306900 · OUTCOME

Pharmacokinetics (PK)

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: GEOMETRIC_MEAN
Unit: (ug/mL)
Interval / dispersion: Geometric Coefficient of Variation
Time frame: Cycles 1-4 (each cycle is 21-28 days)

What was measured

Serum concentrations of TTX-030 will be tabulated

Analysis population: Pharmacokinetic Parameters of Serum TTX-030 by Treatment and Visit at C1D1

Groups in this outcome

TTX-030 (Load+Q2W) + Budigalimab (Q4W) + mFOLFOX6 (Q2W)

Participants 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.

TTX-030 (Load+Q2W) + mFOLFOX6 (Q2W)

Participants 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.

TTX-030 (Load+Q3W) + Budigalimab (Q3W) + Docetaxel (Q3W)

Participants 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 docetaxel at a dose of 75 mg/m2 Q3W on Day 1 of each 21-day treatment cycle.

TTX-030 (Load+Q2W) + Budigalimab (Q4W) + Gemcitabine + Nab-paclitaxel (Days 1, 8, 15)

Participants 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.

TTX-030 (Load+Q2W) + Gemcitabine + Nab-paclitaxel (Days 1, 8, 15)

Participants 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.

TTX-030 (Load+Q3W) + Budigalimab (Q3W)

Participants 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.

TTX-030 (Load+Q3W) + Pembrolizumab (Q3W)

Participants 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

Group	Source count
TTX-030 (Load+Q2W) + Budigalimab (Q4W) + mFOLFOX6 (Q2W)	49
TTX-030 (Load+Q2W) + mFOLFOX6 (Q2W)	6
TTX-030 (Load+Q3W) + Budigalimab (Q3W) + Docetaxel (Q3W)	7
TTX-030 (Load+Q2W) + Budigalimab (Q4W) + Gemcitabine + Nab-paclitaxel (Days 1, 8, 15)	28
TTX-030 (Load+Q2W) + Gemcitabine + Nab-paclitaxel (Days 1, 8, 15)	16
TTX-030 (Load+Q3W) + Budigalimab (Q3W)	41
TTX-030 (Load+Q3W) + Pembrolizumab (Q3W)	7

Reported measurements

Source class 1

Values in (ug/mL) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
TTX-030 (Load+Q2W) + Budigalimab (Q4W) + mFOLFOX6 (Q2W)	503	39.1	Not reported	Not reported	Not reported
TTX-030 (Load+Q2W) + mFOLFOX6 (Q2W)	449	24.1	Not reported	Not reported	Not reported
TTX-030 (Load+Q3W) + Budigalimab (Q3W) + Docetaxel (Q3W)	814	26.4	Not reported	Not reported	Not reported
TTX-030 (Load+Q2W) + Budigalimab (Q4W) + Gemcitabine + Nab-paclitaxel (Days 1, 8, 15)	511	28.1	Not reported	Not reported	Not reported
TTX-030 (Load+Q2W) + Gemcitabine + Nab-paclitaxel (Days 1, 8, 15)	458	15.5	Not reported	Not reported	Not reported
TTX-030 (Load+Q3W) + Budigalimab (Q3W)	601	41.3	Not reported	Not reported	Not reported
TTX-030 (Load+Q3W) + Pembrolizumab (Q3W)	679	31.3	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
39.1
value
503
group Id
OG001
spread
24.1
value
449
group Id
OG002
spread
26.4
value
814
group Id
OG003
spread
28.1
value
511
group Id
OG004
spread
15.5
value
458
group Id
OG005
spread
41.3
value
601
group Id
OG006
spread
31.3
value
679

denoms

counts
group Id
OG000
value
49
group Id
OG001
value
6
group Id
OG002
value
7
group Id
OG003
value
28
group Id
OG004
value
16
group Id
OG005
value
41
group Id
OG006
value
7
units
Participants

description

Serum concentrations of TTX-030 will be tabulated

dispersion Type

Geometric Coefficient of Variation

groups

description
Participants 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
TTX-030 (Load+Q2W) + Budigalimab (Q4W) + mFOLFOX6 (Q2W)
description
Participants 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
OG001
title
TTX-030 (Load+Q2W) + mFOLFOX6 (Q2W)
description
Participants 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 docetaxel at a dose of 75 mg/m2 Q3W on Day 1 of each 21-day treatment cycle.
id
OG002
title
TTX-030 (Load+Q3W) + Budigalimab (Q3W) + Docetaxel (Q3W)
description
Participants 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
TTX-030 (Load+Q2W) + Budigalimab (Q4W) + Gemcitabine + Nab-paclitaxel (Days 1, 8, 15)
description
Participants 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
TTX-030 (Load+Q2W) + Gemcitabine + Nab-paclitaxel (Days 1, 8, 15)
description
Participants 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
TTX-030 (Load+Q3W) + Budigalimab (Q3W)
description
Participants 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
TTX-030 (Load+Q3W) + Pembrolizumab (Q3W)

param Type

GEOMETRIC_MEAN

population Description

Pharmacokinetic Parameters of Serum TTX-030 by Treatment and Visit at C1D1

reporting Status

POSTED

time Frame

Cycles 1-4 (each cycle is 21-28 days)

title

Pharmacokinetics (PK)

type

SECONDARY

unit Of Measure

(ug/mL)

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

Preserved source evidence · Not medical advice