Active — Not RecruitingPhase 2

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

United States194 participantsStarted 2024-03-25

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

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

Exclusion criteria

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

What they're measuring

Progression-free survival (PFS) - Biomarker Enriched Population

Timeframe: Through study completion, an average of 1 year

Trial details

NCT IDNCT06119217

SponsorTrishula Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-02

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