NCT04306900

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 185 (actual)
• Sponsor: Trishula Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 110 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumor, Adult

Interventions

Type	Name	Description
COMBINATION_PRODUCT	TTX-030, budigalimab and mFOLFOX6	Dose and schedule per protocol
COMBINATION_PRODUCT	TTX-030, budigalimab and docetaxel	Dose and schedule per protocol
COMBINATION_PRODUCT	TTX-030 and mFOLFOX6	Dose and schedule per protocol
COMBINATION_PRODUCT	TTX-030 and budigalimab	Dose and schedule per protocol
COMBINATION_PRODUCT	TTX-030, budigalimab, nab-paclitaxel and gemcitabine	Dose and schedule per protocol
COMBINATION_PRODUCT	TTX-030 and pembrolizumab	Dose and schedule per protocol
COMBINATION_PRODUCT	TTX-030, nab-paclitaxel and gemcitabine	Dose and schedule per protocol
COMBINATION_PRODUCT	Budigalimab and mFOLFOX6	Dose and schedule per protocol

Timeline

• Start date: 2020-03-30
• Primary completion: 2022-11-30
• Completion: 2024-03-27
• First posted: 2020-03-13
• Last updated: 2025-07-29
• Results posted: 2025-07-29

Locations

32 sites across 2 countries: United States, South Korea

Regulatory

• FDA-regulated drug study