A Clinical Trial to Test if the Investigational Drug BNT329 is Safe and Potentially Beneficial for People With Advanced Solid Tumors Known to Express the Tumor Marker CA19-9

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBioNTech SE

About this trial

The main goal of this study is to evaluate the safety of BNT329 and to identify the best dose of BNT329. This will be done by measuring the number of side effects that participants experience and how severe they are.

The second goal of this study is to evaluate how well BNT329 works. This will be done by measuring the number of participants who respond to the treatment. The length of time where the tumor does not grow or spread will also be measured.

The study will also evaluate how BNT329 moves into, through, and out of the body and how the treatment affects the body.

Eligibility criteria

Qualifiers

Have an ECOG PS of 0 to 1

Have measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), except for ovarian cancer where participants will be evaluated according to Gynecologic Cancer InterGroup criteria.

Have a life expectancy of ≥3 months in the opinion of the investigator.

Have adequate organ, coagulation, and hematologic function as defined in the protocol.

Disqualifiers

Are enrolled in another investigational study or are subject to exclusion periods from another investigational study.

Have had an inadequate washout period for prior anticancer treatment prior to the first dose of investigational medicinal product (IMP) as defined in the protocol.

Inhaled sprays, topical steroids, or local steroid injections (e.g., intra-articular injection).

Systemic steroids at physiological doses as replacement therapy (e.g., physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency).

Trial design

Treatments tested in this trial

  • BNT329
  • CA19-9-targeting monoclonal antibody

Treatment groups

245 Participants
are divided into 4 treatment groups

Sponsors and collaborators