NCT04306900|CompletedPhase 1ResultsFDA Drug

TTX-030 in Combination With Immunotherapy and/or Chemotherapy in Subjects With Advanced Cancers

Phase 1/1b Study to Evaluate the Safety and Activity of TTX-030 (Anti-CD39) in Combination With Pembrolizumab or Budigalimab and/or Chemotherapy in Subjects With Advanced Solid Tumors

Trishula Therapeutics, Inc.ClinicalTrials.gov

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1 other identifier

TTX-030-002

Study Type

interventional

Target

185

Locations

2 countries

Sites

Timeline

RegisteredMar 2020

StartedMar 2020

CompletionMar 2024

Brief Summary

This is a phase 1/1b study of TTX-030 in combination therapy, an antibody that inhibits CD39 enzymatic activity, leading to accumulation of pro-inflammatory adenosine triphosphate (ATP) and reduction of immunosuppressive adenosine, which may change the tumor microenvironment and promote anti-tumor immune response. This trial will study the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of TTX-030 in combination with immunotherapy and/or standard chemotherapies.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

185

participants targeted

Target at P75+ for phase_1

Timeline

Completed

Started Mar 2020

Longer than P75 for phase_1

Geographic Reach

2 countries

32 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4 years study duration

First Submitted

Initial submission to the registry

March 4, 2020

Completed

9 days until next milestone

First Posted

Study publicly available on registry

March 13, 2020

Completed

17 days until next milestone

Study Start

First participant enrolled

March 30, 2020

Completed

2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed

1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2024

Completed

1.3 years until next milestone

Results Posted

Study results publicly available

July 29, 2025

Completed

Last Updated

July 29, 2025

Status Verified

July 1, 2025

Enrollment Period

2.7 years

First QC Date

March 4, 2020

Results QC Date

June 20, 2025

Last Update Submit

July 9, 2025

Conditions

Solid Tumor, Adult

Keywords

Gastric (gastroesophageal cancer)Advanced Solid TumorColorectal cancerCancerMetastatic Solid TumorCombination TherapyCD39Adenosine PathwayImmunotherapy Immuno-oncologyPD-1 Checkpoint InhibitorDocetaxelBudigalimabABBV-181TTX-030Non-small cell lung cancerUrothelial cell cancerPancreatic cancerPembrolizumabKeytrudaBladder cancerGemcitabineNab-paclitaxel

Outcome Measures

Primary Outcomes (2)

Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
A DLT was defined as the occurrence of any of the following toxicities within the DLT Evaluation Period if judged by the Investigator and Sponsor to be possibly, probably, or definitely related to TTX-030 or budigalimab.
7 day load + 1 cycle (1 cycle is 28 days)
The Incident of Adverse Events
Number of study subjects experiencing adverse events (AEs) and serious adverse events (SAEs). Safety profile will be assessed through laboratory evaluations, vital signs, and physical examinations.
Through study completion, an average of 1 year

Secondary Outcomes (7)

Confirmed Objective Response Rate (ORR)
Through study completion, an average of 1 year
Best Response (BOR)
Through study completion, an average of 1 year
Duration of Response (DOR)
Through study completion, an average of 1 year
Disease Control Rate (DCR)
Through study completion, an average of 1 year
Progression-free Survival (PFS)
Through study completion, an average of 1 year
+2 more secondary outcomes

Study Arms (8)

Combo 1

EXPERIMENTAL

TTX-030 plus budigalimab plus mFOLFOX6

Combination Product: TTX-030, budigalimab and mFOLFOX6

Combo 2

EXPERIMENTAL

TTX-030 plus budigalimab plus docetaxel

Combination Product: TTX-030, budigalimab and docetaxel

Combo 3

EXPERIMENTAL

TTX-030 plus mFOLFOX6

Combination Product: TTX-030 and mFOLFOX6

Combo 4

EXPERIMENTAL

TTX-030 plus pembrolizumab

Combination Product: TTX-030 and pembrolizumab

Combo 5

EXPERIMENTAL

TTX-030 plus budigalimab (selected tumors evaluated in expansion)

Combination Product: TTX-030 and budigalimab

Combo 6

EXPERIMENTAL

TTX-030 plus budigalimab plus nab-paclitaxel + gemcitabine

Combination Product: TTX-030, budigalimab, nab-paclitaxel and gemcitabine

Combo 7

EXPERIMENTAL

TTX-030 plus nab-paclitaxel + gemcitabine

Combination Product: TTX-030, nab-paclitaxel and gemcitabine

Combo 8

EXPERIMENTAL

Budigalimab plus mFOLFOX6

Combination Product: Budigalimab and mFOLFOX6