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

Sponsor: Trishula Therapeutics, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06119217

Patient View

This Phase 2 study evaluates the efficacy and safety of TTX-030 with or without budigalimab, combined with chemotherapy (gemcitabine + nab-paclitaxel), in untreated metastatic PDAC patients. Eligible participants are 18+, with confirmed metastatic PDAC, measurable disease, and ECOG 0-1. Interventions include three combination regimens, administered per protocol.

Patient Parameters

Program Overview

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 Criteria

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.

Abbreviated

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

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