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New drug BNT329 targets Hard-to-Treat cancers in early trial

NCT ID NCT07186842

Disease control Sponsor: BioNTech SE Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 3 times

Summary

This study tests a new drug called BNT329 in people with advanced solid tumors that have a specific marker (CA19-9). The main goals are to check safety and find the best dose. About 245 participants will take part. The drug works by targeting cancer cells and may help control tumor growth, but it is not expected to be a cure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 245 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

May 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria All participants and parts: * Have an Eastern Cooperative Oncology Group performance score of 0 to 1 * Have measurable disease per RECIST v1.1, 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. Parts A, B, and C: * Have a histologically confirmed advanced/metastatic tumor type that is known to express CA19-9: PDAC, carcinoma of the bile ducts, invasive urothelial carcinoma of the bladder and urinary tract, colorectal adenocarcinoma, adenocarcinoma of the esophagogastric junction, gastric adenocarcinoma, endometrial carcinoma, and epithelial ovarian cancer (including adenocarcinoma of the fallopian tube and peritoneal epithelial cancer \[except mesothelioma\]). * Have no available standard of care therapy likely to confer clinical benefit in the opinion of the investigator. Participants must have received all available standard therapies, including targeted therapies based on mutation status (per guidelines from the Food and Drug Administration, American Society of Clinical Oncology, European Society for Medical Oncology, or local guidelines used at the site), and failed at least first-line standard of care therapy prior to enrollment. Part D: * Have a histologically confirmed diagnosis of PDAC. * Must have been offered all available standard therapies including targeted therapies based on mutation status. Established second-line therapies available must not be withheld. * Have radiographic disease progression and no available standard of care therapy likely to confer clinical benefit in the opinion of the investigator. Key Exclusion Criteria All participants and parts: * 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. * Have received systemic steroids (\>10 mg/day of prednisone or its equivalent) or other immunosuppressive therapy within 2 weeks prior to the first dose of IMP. The following are exceptions to this criterion: * 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). * Steroids as pre-medication for hypersensitivity reactions (e.g., computed tomography (CT) scan pre-medication). * Have received any live vaccine within 4 weeks prior to the first dose of IMP or intend to receive a live vaccine during the study. * Have brain metastases or spinal cord compression unless asymptomatic or treated and stable off steroids and anticonvulsants for at least 2 weeks prior to the first dose of IMP. * Have a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening. * Have active gastric and duodenal ulcers, ulcerative colitis, or other gastrointestinal conditions that may cause bleeding or perforation in the opinion of the treating investigator. * Have an active infection that requires systemic therapy within 1 week prior to the first dose of IMP. Participants receiving prophylactic anti-infective therapy (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) may be eligible after discussion with the sponsor. * Have unresolved toxicities from previous anticancer therapy as defined in the protocol. NOTE: Other protocol defined inclusion/exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

bile duct carcinoma bile duct neoplasm colorectal adenocarcinoma colorectal neoplasm endometrial carcinoma endometrium neoplasm gastric adenocarcinoma gastroesophageal junction adenocarcinoma infiltrating bladder urothelial carcinoma ovarian cancer ovarian carcinoma pancreatic ductal adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid cancers

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    17 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Austin Health

    RECRUITING

    Heidelberg, 3084, Australia

  • Florida Cancer Specialists

    RECRUITING

    Orlando, Florida, 32827, United States

  • Hospital San Pedro

    RECRUITING

    Logroño, 26006, Spain

  • Hospital Universitari Vall d'Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario HM Sanchinarro - START Madrid CIOCC

    RECRUITING

    Madrid, 28050, Spain

  • Hospital Universitario Quironsalud Madrid - NEXT Oncology

    RECRUITING

    Pozuelo de Alarcón, 28223, Spain

  • Klinikum der Universität München

    RECRUITING

    München, 81377, Germany

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • Monash Health

    RECRUITING

    Clayton, 3168, Australia

  • Northern Centre for Cancer Research

    RECRUITING

    Newcastle upon Tyne, NE7 7DN, United Kingdom

  • Royal Free Hospital

    RECRUITING

    London, NW3 2QG, United Kingdom

  • SCRI at HCA Health One

    RECRUITING

    Denver, Colorado, 80218, United States

  • St James´s University Hospital

    RECRUITING

    Leeds, LS9 7TF, United Kingdom

  • St. Josef-Hospital im Katholischen Klinikum Bochum

    RECRUITING

    Bochum, 44791, Germany

  • The Christie NHS Foundation Trust

    RECRUITING

    Manchester, M20 4BX, United Kingdom

  • The Royal Marsden Hospital

    RECRUITING

    Sutton, SM2 5PT, United Kingdom

  • Universitaetsklinikum Ulm

    RECRUITING

    Ulm, D-89081, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.