A Clinical Trial Testing the Safety of BNT327 (an Investigational Drug) and How Well it Works When Combined With Chemotherapy for People Who Have Not Been Treated Yet for Pancreatic Cancer

Sponsor
BioNTech SE
Study ID
NCT07255404
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Pancreatic Ductal Adenocarcinoma (PDAC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pumitamig — DRUG
    Intravenous (IV) infusion
  • Nab-paclitaxel — DRUG
    IV infusion
  • Gemcitabine — DRUG
    IV infusion
  • mFOLFIRINOX — DRUG
    IV infusion

Study Details

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 (BNT327) in combination with chemotherapy.

Key Dates

Start date
Dec 4, 2025
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Aug 31, 2028

Study Design

Enrollment
105 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Pumitamig (dose level 1) + chemotherapy
    Participants will be administered pumitamig plus chemotherapy regimen.
  • Experimental: Arm 2: Pumitamig (dose level 2) + chemotherapy
    Participants will be administered pumitamig plus chemotherapy regimen.
  • Experimental: Arm 3: Pumitamig (dose level 2) + chemotherapy
    Participants will be administered pumitamig plus chemotherapy regimen.
  • Experimental: Arm 4A (exploratory): Pumitamig (dose level 2) + treatment of physician's choice chemotherapy
    Participants will be administered pumitamig plus chemotherapy regimen.
  • Experimental: Arm 4B (exploratory): Pumitamig (dose level 2) + treatment of physician's choice chemotherapy
    Participants will be administered pumitamig plus chemotherapy regimen

Primary Outcome Measure

Confirmed overall response rate [ Time Frame: Up to 24 months ]

Central Contacts

Related Studies