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

Conditions

• Advanced Solid Cancers

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• BNT329 — DRUG
  Intravenous (IV) infusion
• CA19-9-targeting monoclonal antibody — DRUG
  Monoclonal antibody

Study Details

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.

Key Dates

Start date

Nov 18, 2025

Status verified

May 2026

Primary completion

May 31, 2030

Completion

May 31, 2030

Study Design

Enrollment

245 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Dose Escalation - Part A
  BNT329 administered once every 3 weeks at protocol-defined dose levels
• Experimental: Dose Escalation - Part B
  BNT329 administered once every 2 weeks at protocol-defined dose levels
• Experimental: Dose Escalation: Part C
  BNT329 administered after pre-dosing with a CA19-9 targeting monoclonal antibody
• Experimental: Dose Expansion - Part D
  Participants will be randomized to one of two arms evaluating two different doses as selected from Parts A, B, and C

Primary Outcome Measure

Parts A, B, and C - Occurrence of dose-limiting toxicities within a participant [ Time Frame: First 21 days (Part A) or 28 days (Part B) after the first dose of BNT329. ]

Central Contacts

• BioNTech clinical trials patient information
  +49 6131 9084
  [email protected]

Locations (2)

Find similar trials in Orlando, FL