Status:
ACTIVE_NOT_RECRUITING
Phase 2 Study of TTX-030 and Chemotherapy With or Without Budigalimab for 1L mPDAC Patients
Lead Sponsor:
Trishula Therapeutics, Inc.
Collaborating Sponsors:
AbbVie
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 (gemcita...
Eligibility Criteria
Inclusion
- Abbreviated
- 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
- 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
Key Trial Info
Start Date :
March 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2027
Estimated Enrollment :
194 Patients enrolled
Trial Details
Trial ID
NCT06119217
Start Date
March 25 2024
End Date
June 1 2027
Last Update
December 4 2024
Active Locations (64)
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1
Investigative Site
Tucson, Arizona, United States, 85704
2
Investigative SIte
Hot Springs, Arkansas, United States, 71913
3
Investigative Site
Bakersfield, California, United States, 93309
4
Investigative Site
Fullerton, California, United States, 92835