Phase 2
N=194
Phase 2 Study of TTX-030 and Chemotherapy With or Without Budigalimab for 1L mPDAC Patients
Pancreatic Cancer
Bottom Line
View on ClinicalTrials.gov: NCT06119217 ↗Enrolled (actual)
194
Serious AEs
55.2%
Results posted
May 2026
Primary outcome: Primary: Progression-free Survival (PFS) - Biomarker Enriched Population — 5.5; 7.3; 5.9 months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- TTX-030, nab-paclitaxel and gemcitabine (Combination_product); TTX-030, budigalimab, nab-paclitaxel and gemcitabine (Combination_product); Nab-Paclitaxel and gemcitabine (Combination_product)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Trishula Therapeutics, Inc.
- Primary completion
- Nov 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival (PFS) - Biomarker Enriched Population |
5.5; 7.3; 5.9 | — |
| SECONDARY Progression-free Survival (PFS) - Overall Population |
5.5; 7.3; 5.7 | — |
| SECONDARY Objective Response Rate (ORR) - Biomarker Enriched Population |
0.36; 0.38; 0.42 | — |
| SECONDARY Overall Survival (OS) - Biomarker Enriched Population |
0.48; 0.40; 0.46 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events |
64; 59; 63 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT06119217). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.