NCT03884556

TTX-030 Single Agent and in Combination With Immunotherapy or Chemotherapy for Patients With Advanced Cancers

Phase 1/1b Study of the Safety of TTX-030 as a Single Agent and in Combination With Pembrolizumab or Chemotherapy in Patients With Lymphoma or Solid Tumor Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Trishula Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1/1b study of TTX-030, 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, and anti-tumor activity of TTX-030 as a single agent and in combination with an approved anti-PD-1 immunotherapy and standard chemotherapies.

Conditions

• Solid Tumor
• Lymphoma

Interventions

Type	Name	Description
DRUG	TTX-030	Variable dose and schedule
DRUG	Pembrolizumab	Dose and schedule per standard of care
DRUG	Gemcitabine	Dose and schedule per standard of care
DRUG	nab paclitaxel	Dose and schedule per standard of care

Timeline

• Start date: 2019-04-10
• Primary completion: 2022-11-30
• Completion: 2023-09-29
• First posted: 2019-03-21
• Last updated: 2025-07-02
• Results posted: 2025-07-02

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated drug study