Recruiting
Phase 1
Phase 2

BNT329

Sponsor:

BioNTech SE

Code:

NCT07186842

Conditions

Advanced Solid Cancers

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BNT329

CA19-9-targeting monoclonal antibody

Study Details

Brief 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

Study ID

NCT07186842

Start date

Nov 18, 2025

Status verified date

Aug, 2026

Completion date

May, 2030

Anticipated

Primary completion date

May, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

245 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

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/or C

Interventions

BNT329

Intravenous (IV) infusion

CA19-9-targeting monoclonal antibody

Monoclonal antibody

Primary outcome measure

  • Parts A and B - 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. ]
  • Parts A, B, and D - Occurrence of treatment-emergent adverse events (TEAEs), Grade ≥3 TEAEs, serious adverse events (SAEs), treatment-related TEAEs, treatment-related Grade ≥3 TEAEs, and treatment-related SAEs [ Time Frame: From first dose of BNT329 until 60 days after the last dose of BNT329 (up to 26 months). ]
  • Parts A, B, and D - Occurrence of dose interruptions, reductions, and discontinuation of BNT329 due to TEAEs [ Time Frame: From the time of initiation of the first dose of BNT329 until 60 days after the last dose of BNT329 (up to 26 months). ]
  • Part D - Objective response rate (ORR) [ Time Frame: From first dose of BNT329 until end of study (up to approximately 36 months). ]

Central Contacts and Locations

Central contacts

BioNTech clinical trials patient information

+49 6131 9084patients@biontech.de

Locations

SCRI at HCA Health One

Recruiting

Denver, Colorado, United States, 80218

Florida Cancer Specialists

Recruiting

Orlando, Florida, United States, 32827

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

More Information

Sponsor

BioNTech SE

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Keywords

  • Anti-drug conjugate (ADC)
  • Bile duct cancer
  • CA19-9
  • Colorectal cancer
  • Endometrial cancer
  • Gastric adenocarcinoma
  • Gastroesophageal junction cancer
  • Invasive urothelial carcinoma of the bladder and urinary tract
  • Ovarian cancer
  • Pancreatic ductal adenocarcinoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-23. This information was provided to ClinicalTrials.gov by BioNTech SE on 2026-08-27.