Clinical trialPhase 2Recruiting
A Clinical Trial Testing the Safety of Pumitamig (an Investigational Drug) and How Well it Works When Combined With Chemotherapy for People Who Have Not Been Treated Yet for Pancreatic Cancer
A Phase II, Multi-site, Randomized, Open-label, Trial of Pumitamig in Combination With Chemotherapy in Patients With Metastatic Pancreatic Cancer
- Outcome
- Ongoing
- Phase
- Phase 2
- Status
- Recruiting
- Study type
- Interventional
- Start
- 4 December 2025
- Expected end
- August 2028
- Enrollment
- 105 participants
- Sites
- 24
- Primary outcomes
- Confirmed overall response rate; Occurrence of treatment emergent adverse events (TEAEs) by severity; Occurrence of dose interruptions, reductions, and discontinuations due to TEAEs
- Sponsor
- Industry
- Results posted
- No
- Last update
- 28 July 2026
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Brief summary public domain (ClinicalTrials.gov)
This study will enroll adults with confirmed metastatic pancreatic ductal adenocarcinoma (PDAC, systemic PDAC treatment naïve), Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1, and adequate organ function. Participants will receive pumitamig (also known as BNT327, BMS-986545, or PM8002) in combination with chemotherapy.
Detailed description public domain (ClinicalTrials.gov)
Participants will be assigned to treatment arms with modified (m) FOLFIRINOX administration (Treatment Arms 1 and 2) or the treatment arm with nab-paclitaxel + gemcitabine administration (Treatment Arm 3) based on the physician's choice of chemotherapy. Study participants assigned to arms with mFOLFIRINOX administration, will be randomized 1:1 to one of the two arms (Treatment Arms 1 or 2). Once enrollment of Treatment Arms 1 to 3 has been completed, enrollment into the exploratory cohorts (Treatment Arms 4A and 4B) will be opened. There will be a screening period of up to 28 days, followed by a treatment period lasting up to 2 years. After administration of the last dose of study treatment, participants will be followed-up for safety for up to 90 days or until the participant initiates new anticancer treatment (e.g., systemic, radiotherapy/surgery). Thereafter, survival follow-up will be conducted until the participant dies or withdraws consent for survival status follow-up, loss of contact, or study termination (whichever occurs first).