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RECRUITING Phase 1

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 · View on ClinicalTrials.gov ↗

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 Studied

Interventions

  • DRUG BNT329
  • DRUG CA19-9-targeting monoclonal antibody

Study Locations (4)

Other

  • Hospital Universitario HM Sanchinarro - START Madrid CIOCC — Madrid
  • Hospital Universitario Quironsalud Madrid - NEXT Oncology — Pozuelo de Alarcón
  • The Royal Marsden Hospital — Sutton

Florida

  • Florida Cancer Specialists — Orlando

Trial Details

FieldValue
Enrollment Target 245 participants
Start Date 2025-11-18
Est. Completion 2030-05
Phase Phase 1

Sponsor

BioNTech SE

123 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07186842

The ClinicalTrials.gov registry entry for NCT07186842 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 245 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioNTech SE, which has 123 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Advanced Solid Cancers appearing as the primary indexed condition, and to 2 interventions — of which BNT329 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07186842 reports 4 study locations spanning 2 distinct geographic areas — top geographies include Other, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT07186842 about?

NCT07186842 is a clinical study titled "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". 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 d...

What is the current status of trial NCT07186842?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 245 participants. The study started on 2025-11-18. Estimated completion is 2030-05.

What conditions does trial NCT07186842 study?

This clinical trial studies the following conditions: Advanced Solid Cancers. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07186842?

The interventions under investigation include: BNT329 (DRUG), CA19-9-targeting monoclonal antibody (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07186842?

This trial is sponsored by BioNTech SE, which has 123 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT07186842 being conducted?

This trial has 4 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial