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Phase 2 Study of TTX-030 and Chemotherapy With or Without Budigalimab for 1L mPDAC Patients | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

Phase 2 Study of TTX-030 and Chemotherapy With or Without Budigalimab for 1L mPDAC Patients

An Open-Label Multicenter 3-Arm Randomized Phase 2 Study to Assess the Efficacy and Safety of TTX-030 and Chemotherapy With or Without Budigalimab, Compared to Chemotherapy Alone, for the Treatment of Patients Not Previously Treated for Metastatic Pancreatic Adenocarcinoma

NCT06119217•Trishula Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

This is a Phase 2, multicenter, open-label, 3-arm, randomized, parallel group study to evaluate the efficacy and safety of TTX-030 with or without budigalimab in combination with chemotherapy (gemcitabine + nab-paclitaxel) in subjects with metastatic PDAC who did not have prior treatment for metastatic disease and are eligible to receive gemcitabine and nab-paclitaxel chemotherapy as SOC.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age 18 years or older, is willing and able to provide informed consent
•2. Histologically or cytologically confirmed diagnosis of metastatic PDAC.
•3. No prior systemic treatment for metastatic disease.
•4. Evidence of measurable disease per RECIST 1.1.
•5. Appropriate for treatment with nab-paclitaxel and gemcitabine chemotherapy.
•6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.

Exclusion Criteria

•1. History of clinically significant allergy or hypersensitivity to planned study treatment components or to any monoclonal antibody
•2. Use of investigational agent within 14 days prior to the first dose of study drug
•3. History of autoimmune disease
•4. Subject has received live vaccine within 28 days prior to the first dose of study drug
•5. Has uncontrolled intercurrent illness

Locations (64)

Investigative Site

Tucson, Arizona, United States

Investigative SIte

Hot Springs, Arkansas, United States

Investigative Site

Bakersfield, California, United States

Investigative Site

Fullerton, California, United States

Investigative Site

Los Angeles, California, United States

Investigative Site

Denver, Colorado, United States

Investigative Site

St. Petersburg, Florida, United States

Investigative Site

West Palm Beach, Florida, United States

Investigative Site

Atlanta, Georgia, United States

Investigative Site

Wichita, Kansas, United States

Key Dates

Start Date

March 25, 2024

Primary Completion Date

February 1, 2027

Completion Date

June 1, 2027

Last Updated

December 4, 2024

Enrollment

194

ACTUAL participants

Conditions

Pancreatic Cancer

Interventions

TTX-030, nab-paclitaxel and gemcitabine

COMBINATION_PRODUCT

TTX-030, budigalimab, nab-paclitaxel and gemcitabine

COMBINATION_PRODUCT

Nab-Paclitaxel and gemcitabine

COMBINATION_PRODUCT

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 4, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Phase 2 Study of TTX-030 and Chemotherapy With or Without Budigalimab for 1L mPDAC Patients

Inclusion Criteria

Exclusion Criteria

Testing A New Anti-cancer Drug Combination, Entinostat and ZEN003694, for Advanced and Refractory Solid Tumors

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

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