Clinical trial · Interventional
Phase 2 Study of TTX-030 and Chemotherapy With or Without Budigalimab for 1L mPDAC Patients
An Open-Label Multicenter 3-Arm Randomized Phase 2 Study to Assess the Efficacy and Safety of TTX-030 and Chemotherapy With or Without Budigalimab, Compared to Chemotherapy Alone, for the Treatment of Patients Not Previously Treated for Metastatic Pancreatic Adenocarcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nab-Paclitaxel and gemcitabine | Combination Product | — | UNRESOLVED |
| TTX-030, budigalimab, nab-paclitaxel and gemcitabine | Combination Product | — | UNRESOLVED |
| TTX-030, nab-paclitaxel and gemcitabine | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- TTX-030 plus nab-paclitaxel and gemcitabine
- interventionNames
- Combination Product: TTX-030, nab-paclitaxel and gemcitabine
- type
- EXPERIMENTAL
- label
- Arm 2
- description
- TTX-030 plus budigalimab plus nab-paclitaxel and gemcitabine
- interventionNames
- Combination Product: TTX-030, budigalimab, nab-paclitaxel and gemcitabine
- type
- ACTIVE_COMPARATOR
- label
- Arm 3
- description
- Nab-Paclitaxel and gemcitabine
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Abbreviated 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
References
Publications (0)
Data not yet available