A Clinical Study to Test if an Investigational Treatment Called BNT326 is Safe and Potentially Beneficial When Used Alone or in Combination With Other Investigational Treatments Such as BNT327, for People With Advanced Malignant Tumors

Trial status:Will Be Recruiting
Trial ID:
BNT326-01
NCT ID:
NCT07070232
EudraCT ID:
N/A
EU Trial (CTIS) Number:
2024-517261-16-00
Sponsor:
The sponsor of a clinical trial is the company, institution or individual that takes responsibility for initiating, managing, and/or financing a clinical investigation. BioNTech collaborates with other pharmaceutical companies or institutions (collaborators) to develop certain new medicines. In particular cases BioNTech's collaborators are leading specific clinical trials and are acting as sponsors accordingly.
BioNTech SE
Will Be Recruiting

Trial Details

This study will evaluate the safety, efficacy, optimal dose, and pharmacokinetics (PK) of BNT326 as monotherapy (Part 1) and as combination treatment with immunotherapeutic agents (Part 2) in participants with histologically or cytologically confirmed solid tumors that are advanced (i.e., either metastatic or recurrent tumors with no further definitive treatment possible) and/or have relapsed/progressed after prior therapy.

Medical Condition
  • Solid Tumors
    • Trial Drug
  • BNT326
    • See more
  • BNT327
  • Itraconazole
  • Paroxetine
    • Phase
    Phase 1/Phase 2
    Type
    Interventional
    Estimated Enrolment
    550
    Estimated Trial Date
    Jul 2025 - May 2028

    Trial Participant Requirements

    Age
    18+ years
    Sex
    Female & Male
    Healthy Volunteers
    No

    Trial Locations

    No locations found.