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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

NCT07186842 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 245

Last updated 2026-05-13

No results posted yet for this study

Summary

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.

Conditions

  • Advanced Solid Cancers

Interventions

DRUG

BNT329

Intravenous (IV) infusion

DRUG

CA19-9-targeting monoclonal antibody

Monoclonal antibody

Sponsors & Collaborators

Principal Investigators

  • BioNTech Response Person · BioNTech SE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-18
Primary Completion
2030-05-31
Completion
2030-05-31
FDA Drug
Yes

Countries

  • United States
  • Germany
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07186842 on ClinicalTrials.gov