BNT329 for Advanced solid tumours | Pancreatic adenocarcinoma (PDAC) | Cholangiocarcinoma | Urothelial carcinoma | Colorectal adenocarcinoma | Ovarian epithelial cancer | Endometrial cancer | Adenocarcinoma of the gastroesophageal junction

Inclusion criteria

• {"criterion_text":"- All participants and parts: Are ≥18 years of age. 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."}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Parts A, B, and C: 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, and failed at least first-line standard of care therapy prior to enrollment."}
• {"criterion_text":"- Part D all participants: 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 withheld. Have radiographic disease progression and no available standard of care therapy likely to confer clinical benefit in the opinion of the investigator."}

Exclusion criteria

• {"criterion_text":"- All participants and parts: Are enrolled in another investigational trial or are subject to exclusion periods from another investigational trial. 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."}
• {"criterion_text":"- All participants and parts: 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 • Systemic steroids at physiological doses as replacement therapy • Steroids as pre-medication for hypersensitivity reactions"}
• {"criterion_text":"- All participants and parts: Have received any live vaccine within 4 weeks prior to the first dose of IMP or intend to receive a live vaccine during the trial."}
• {"criterion_text":"- All participants and parts: 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."}
• {"criterion_text":"- All participants and parts: 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."}
• {"criterion_text":"- All participants and parts: 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."}
• {"criterion_text":"- All participants and parts: 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."}
• {"criterion_text":"- All participants and parts: Have unresolved toxicities from previous anticancer therapy as defined in the protocol."}

Primary endpoints

• {"endpoint_text":"- Parts A, B, and C: Occurrence of dose-limiting toxicities (DLTs) within a participant per dose level/cohort.","definition_or_measurement_approach":"Assessed per dose level/cohort as occurrence of dose-limiting toxicities (DLTs) within a participant; DLTs used to inform dose-escalation decisions."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Assessed per dose level/cohort as occurrence and grading of TEAEs (including Grade ≥3) and SAEs; treatment-relatedness assessed per protocol."}
• {"endpoint_text":"- All parts: Occurrence of dose interruptions, reductions, and discontinuation of BNT329 due to TEAEs per dose level/cohort.","definition_or_measurement_approach":"Captured per dose level/cohort as events of dose interruption, dose reduction, or discontinuation of BNT329 attributable to TEAEs."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"ORR defined as proportion with confirmed CR or PR (investigator assessment) as best overall response; assessed per dose level/arm according to RECIST 1.1."}

Secondary endpoints

• {"endpoint_text":"- All parts: Assessment of PK parameters derived from serum concentrations of CA19-9-unbound ADC, CA19-9-unbound total anti-CA19-9 antibody, and unconjugated YL0010014 payload per dose level/cohort. Assessment of area under the curve, maximum concentration, time to reach maximum concentration, and terminal half-life","definition_or_measurement_approach":"PK parameters derived from serum concentrations of specified analytes; includes AUC, Cmax, Tmax, and terminal half-life per dose level/cohort."}
• {"endpoint_text":"- Parts A, B, and C: 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.","definition_or_measurement_approach":"ORR per dose level/arm defined as proportion with confirmed CR or PR by investigator assessment (RECIST 1.1)."}
• {"endpoint_text":"- All parts: Disease control rate (DCR) Per dose level/arm. Defined as as the proportion of participants in whom a CR or PR or SD (assessed at least 6 weeks is observed as best ORR per investigator’s assessment.","definition_or_measurement_approach":"DCR defined as proportion with CR, PR, or stable disease (assessed at least 6 weeks) as best overall response per investigator assessment."}
• {"endpoint_text":"- All parts: Duration of response (DOR) Per dose level/arm. Defined as the time from first objective response (CR or PR) to first occurrence of objective tumor progression (PD) or death from any cause, whichever occurs first.","definition_or_measurement_approach":"DOR measured as time from first documented CR/PR to objective progression or death, whichever occurs first."}
• {"endpoint_text":"- All parts: Anti-drug antibody (ADA) prevalence per dose level/cohort. Defined as the proportion of participants who are ADA positive at any timepoint (either baseline or post-baseline) (if data permit).","definition_or_measurement_approach":"ADA prevalence defined as proportion ADA-positive at any timepoint (baseline or post-baseline), if data permit."}
• {"endpoint_text":"- All parts - ADA incidence per dose level/cohort. Defined as the proportion of participants having treatment-emergent ADA (if data permit).","definition_or_measurement_approach":"ADA incidence defined as proportion with treatment-emergent ADA per dose level/cohort, if data permit."}

Germany

Earliest CTIS Part Ii Submission Date

09-01-2026

Latest Decision Or Authorization Date

30-01-2026

Processing Time Days

21

Number Of Sites

3

Number Of Participants

45

Spain

Earliest CTIS Part Ii Submission Date

12-12-2025

Latest Decision Or Authorization Date

29-01-2026

Processing Time Days

48

Number Of Sites

4

Number Of Participants

45

Primary sponsor

Full Name

BioNTech SE

Organisation Type

Pharmaceutical company

Country Of Registered Address

Germany

Contract research organisations

Name

IQVIA Limited

Responsibilities

Vendor Management, Project Management, Data Management

Name

4G Clinical B.V.

Third parties

• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Vendor Management, Project Management, Data Management","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"LabCorp is used as the central lab for the study, as well as for exploratory endpoints, processing of blood samples for exploratory research e.g. ctDNA etc.","organisation_type":"Pharmaceutical company"}
• {"country":"Netherlands","full_name":"4G Clinical B.V.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"LabCorp is used as the central lab for the study, as well as for exploratory endpoints, processing of blood samples for exploratory research e.g. ctDNA etc.","organisation_type":"Pharmaceutical company"}
• {"country":"Singapore","full_name":"Labcorp Development (Asia) Pte Ltd","duties_or_roles":"LabCorp is used as the central lab for the study, as well as for exploratory endpoints, processing of blood samples for exploratory research e.g. ctDNA etc.","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"PK assays, ADA and CA19-9 for BNT329","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"Long-Term storage for clinical samples at the end of trial","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Almac Clinical Services LLC","duties_or_roles":"IMP supply management, secondary packaging and labelling","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"IMP supply management, secondary packaging and labelling, QP release and distribution","organisation_type":"Pharmaceutical company"}