Open
Actively Recruiting
Phase 2 Study of TTX-030 and Chemotherapy With or Without Budigalimab for 1L mPDAC Patients
About
Brief 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.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
Abbreviated 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.
Abbreviated 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
Join this Trial
Contact our clinical trial navigators for opportunities that may be suitable for you
Study Stats
Protocol No.
24-000128
Category
Pancreatic Cancer
Principal Investigator
Location
- UCLA Porter Ranch
- UCLA San Luis Obispo
- UCLA Santa Barbara
- UCLA Santa Monica
- UCLA Torrance
- UCLA Westlake Village
- UCLA Westwood