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 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: BNT329-012025-522613-26-00
• Study Type: interventional
• Target: 245
• Locations: 4 countries
• Sites: 8

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Parts A, B, and C - Occurrence of dose-limiting toxicities within a participant

  Per dose level/cohort.

  First 21 days (Part A) or 28 days (Part B) after the first dose of BNT329.

• All parts - 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

  Per dose level/cohort/arm.

  From first dose of BNT329 until 60 days after the last dose of BNT329 (up to 26 months).

• All parts - Occurrence of dose interruptions, reductions, and discontinuation of BNT329 due to TEAEs

  Per dose level/cohort/arm.

  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)

  Per dose level/arm. Defined as the proportion of participants in whom a confirmed complete response (CR) or partial response (PR) (based on the investigator's assessment) is observed as best overall response.

  From first dose of BNT329 until end of study (up to approximately 36 months).

Secondary Outcomes (9)

• All parts - Assessment of area under the curve derived from serum concentrations of CA19-9-unbound ADC, CA19-9-unbound total anti-CA19-9 antibody, and unconjugated YL0010014 payload

  First 21 days (Part A) or 28 days (Part B) after the first dose of BNT329.

• All parts - Assessment of maximum concentration derived from serum concentrations of CA19-9-unbound ADC, CA19-9-unbound total anti-CA19 antibody, and unconjugated YL0010014 payload

  First 21 days (Part A) or 28 days (Part B) after the first dose of BNT329.

• All parts - Assessment of time to reach maximum concentration derived from serum concentrations of CA19-9-unbound ADC, CA19-9-unbound total anti-CA19-9 antibody, and unconjugated YL0010014 payload

  First 21 days (Part A) or 28 days (Part B) after the first dose of BNT329.

• All parts - Assessment of terminal half-life derived from serum concentrations of CA19-9-unbound ADC, CA19-9-unbound total anti-CA19-9 antibody, and unconjugated YL0010014 payload

  First 21 days (Part A) or 28 days (Part B) after the first dose of BNT329.

• Parts A, B, and C - ORR

  From first dose of BNT329 until end of study (up to approximately 36 months).

Study Arms (4)

Dose Escalation - Part A

EXPERIMENTAL

BNT329 administered once every 3 weeks at protocol-defined dose levels

Drug: BNT329

Dose Escalation - Part B

EXPERIMENTAL

BNT329 administered once every 2 weeks at protocol-defined dose levels

Drug: BNT329

Dose Escalation: Part C

EXPERIMENTAL

BNT329 administered after pre-dosing with a CA19-9 targeting monoclonal antibody

Drug: BNT329; Drug: CA19-9-targeting monoclonal antibody

Dose Expansion - Part D

EXPERIMENTAL

Participants will be randomized to one of two arms evaluating two different doses as selected from Parts A, B, and C

Drug: BNT329

Interventions

BNT329 DRUG

Intravenous (IV) infusion

Dose Escalation - Part A; Dose Escalation - Part B; Dose Escalation: Part C; Dose Expansion - Part D

CA19-9-targeting monoclonal antibody DRUG

Monoclonal antibody

Dose Escalation: Part C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All participants and parts:
• Have an ECOG PS of 0 to 1
• Have measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), 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, 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.
• Have received at least one prior systemic treatment regimen for advanced/metastatic disease. Participants who have progressed on \<6 months of (neo)adjuvant chemotherapy can be included in the study.
• Have radiographic disease progression and no available standard of care therapy likely to confer clinical benefit in the opinion of the investigator.

You may not qualify if:

• All participants and parts:
• 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 requires 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.

Sponsors & Collaborators

• BioNTech SE: lead

Study Sites (8)

Florida Cancer Specialists

Orlando, Florida, 32827, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

St. Josef-Hospital im Katholischen Klinikum Bochum

Bochum, 44791, Germany

RECRUITING

Hospital San Pedro

Logroño, 26006, Spain

RECRUITING

Hospital Universitario HM Sanchinarro - START Madrid CIOCC

Madrid, 28050, Spain

RECRUITING

Hospital Universitario Quironsalud Madrid - NEXT Oncology

Pozuelo de Alarcón, 28223, Spain

RECRUITING

Northern Centre for Cancer Research

Newcastle upon Tyne, NE7 7DN, United Kingdom

RECRUITING

The Royal Marsden Hospital

Sutton, SM2 5PT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Bile Duct Neoplasms; Colorectal Neoplasms; Endometrial Neoplasms; Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• BioNTech Response Person

  BioNTech SE

  STUDY DIRECTOR

Central Study Contacts

BioNTech clinical trials patient information

CONTACT

+49 6131 9084; patients@biontech.de

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 22, 2025
• Study Start: November 18, 2025
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): May 1, 2030
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2); US (2); DE (1); ES (3)