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

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.

Trial Details

NCT ID
NCT07255404
Phase
PHASE2
Sponsor
BioNTech SE
Status
RECRUITING
Cancer Type
Pancreatic Cancer
Interventions
  • Pumitamig
  • Nab-paclitaxel
  • Gemcitabine
  • mFOLFIRINOX
Locations (sample)
  • Beijing, China|39.9075,116.39723
  • Chengdu, China|30.66667,104.06667
  • Guangzhou, China|23.11667,113.25
  • Hangzhou, China|30.29365,120.16142
  • Nanchang, China|28.68396,115.85306

Key Eligibility Criteria

  • Have a histologically or cytologically confirmed metastatic PDAC. A tissue sample, archival or fresh, must be provided during the screening period.…
  • Have not received prior systemic therapy for unresectable metastatic PDAC. For participants who have received prior induction chemotherapy, concurr…
  • Have at least one measurable lesion as the targeted lesion based on RECIST v1.1. Lesions treated after prior local treatment (radiotherapy, ablatio…
  • Agree to discontinue strong inhibitors or inducers of cytochrome P450 enzyme (CYP3A), CYP2C8, glucuronosyltransferase 1 family, polypeptide A clust…

For full eligibility, visit ClinicalTrials.gov.

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