TTX-030 + Chemotherapy for Pancreatic Cancer

Recruiting in Palo Alto (17 mi)

+58 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Trishula Therapeutics, Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

This trial is for adults over 18 with metastatic pancreatic cancer (mPDAC) who haven't had treatment for their advanced disease yet. They should be able to receive standard chemotherapy and have a performance status indicating they are fully active or restricted in physically strenuous activity but ambulatory.

Inclusion Criteria

I am 18 or older and can agree to participate in the study.

Evidence of measurable disease per RECIST 1.1

My cancer is a type of pancreatic cancer that has spread.

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Exclusion Criteria

I do not have any unmanaged ongoing illnesses.

I have not received a live vaccine in the last 28 days.

History of clinically significant allergy or hypersensitivity to planned study treatment components or to any monoclonal antibody

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Treatment Details

Interventions

Budigalimab (Monoclonal Antibodies)
TTX-030 (Monoclonal Antibodies)

Trial OverviewThe study tests TTX-030 combined with standard chemo (nab-paclitaxel and gemcitabine), both with and without another drug called budigalimab, against just the chemo alone. It's to see which combination works best for treating mPDAC.

Participant Groups

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm 2Experimental Treatment1 Intervention

TTX-030 plus budigalimab plus nab-paclitaxel and gemcitabine

Group II: Arm 1Experimental Treatment1 Intervention

TTX-030 plus nab-paclitaxel and gemcitabine

Group III: Arm 3Active Control1 Intervention

Nab-Paclitaxel and gemcitabine