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

Phase 1

Completed

• Conditions: Solid Tumor, Adult

• Registration Number: NCT04306900
• Lead Sponsor: Trishula Therapeutics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-04
• Study First Submitted QC: 2020-03-10
• Study First Posted: 2020-03-13
• Study Start: 2020-03-30
• Primary Completion: 2022-11-30
• Study Completion: 2024-03-27
• Results First Submitted: 2025-06-20
• Status Verified: 2025-07
• Results First Submitted QC: 2025-07-09
• Last Update Submitted: 2025-07-09
• Results First Posted: 2025-07-29
• Last Update Posted: 2025-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 185

Inclusion Criteria

1. Age 18 years or older, is willing and able to provide informed consent
2. Histologically confirmed diagnosis of unresectable or metastatic solid tumor malignancy in selected tumor types
3. Life expectancy > 12 weeks
4. ECOG performance status of 0-1

Abbreviated

Exclusion Criteria

1. History of allergy or hypersensitivity to study treatment components. Patients with a history of severe hypersensitivity reaction to any monoclonal antibody.
2. Use of investigational agent within 28 days prior to the first dose of study treatment and throughout the study
3. Receiving high-dose systemic steroid therapy or any other form of immunosuppressive therapy
4. History of severe autoimmune disease
5. Uncontrolled intercurrent illness or other active malignancy requiring ongoing treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)	7 day load + 1 cycle (1 cycle is 28 days)	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.
The Incident of Adverse Events	Through study completion, an average of 1 year	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.

Secondary Outcome Measures

Name	Time	Method
Confirmed Objective Response Rate (ORR)	Through study completion, an average of 1 year	ORR is defined as the proportion of subjects with CR or PR.
Best Response (BOR)	Through study completion, an average of 1 year	The BOR was defined as the best response (in the order of CR, PR, stable disease, and PD) by RECIST 1.1 documented from first dose until the end of study, first disease progression, death, or start of new anticancer therapy, whichever was earliest.
Duration of Response (DOR)	Through study completion, an average of 1 year	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.
Disease Control Rate (DCR)	Through study completion, an average of 1 year	DCR is defined as the proportion of subjects with CR, PR, or SD per RECIST 1.1
Progression-free Survival (PFS)	Through study completion, an average of 1 year	PFS is measured from documentation of progression or death from any cause, whichever occurs first
Pharmacokinetics (PK)	Cycles 1-4 (each cycle is 21-28 days)	Serum concentrations of TTX-030 will be tabulated
Overall Survival (OS)	Through study completion, an average of 1 year	OS was defined as the time interval from the first dose of study treatment to death from any cause. Participants who were lost to follow-up or survived until the end of the study were censored at the last date that they were known to be alive. Medians, Q1, and Q3 of OS and the proportion of participants who were alive at 3, 6, 9, and 12 months from Study Day 1 were derived using KM methods.

Trial Locations

Locations (31)

HonorHealth Research Institute; 🇺🇸 Scottsdale, Arizona, United States

City of Hope Medical Center Clinical Trials Office; 🇺🇸 Duarte, California, United States

University of Southern California; 🇺🇸 Los Angeles, California, United States

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

UCLA Hematology/Oncology; 🇺🇸 Los Angeles, California, United States

Chao Family Comprehensive CC, UCI; 🇺🇸 Orange, California, United States

UC Davis Comprehensive Cancer Center; 🇺🇸 Sacramento, California, United States

Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine; 🇺🇸 Miami, Florida, United States

Ocala Oncology Center PL; 🇺🇸 Ocala, Florida, United States

Orlando Health UF Health Cancer Center; 🇺🇸 Orlando, Florida, United States

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