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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

BioNTech SE

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

13 Mar 2026 → ongoing

Decision date (initial)

2026-01-30

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2025-522613-26-00

ClinicalTrials.gov

NCT07186842

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic, Efficacy

Part A, B, C and D: To assess the safety and tolerability of BNT329.
Part D: To evaluate the anti-tumor activity of BNT329 according to RECIST 1.1.

Secondary objectives 3

1. Part A, B, C and D: To characterize the pharmacokinetic (PK) profile of BNT329.
2. Part A, B, C and D: To evaluate the anti-tumor activity of BNT329 according to RECIST 1.1.
3. Part A, B, C and D: To evaluate the immunogenicity of BNT329.

Conditions and MedDRA coding

Advanced Solid Cancers

Study design 4 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. 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.
2. 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
3. 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.
4. 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 8

1. 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.
2. 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
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. All participants and parts: Have unresolved toxicities from previous anticancer therapy as defined in the protocol.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 4

1. Parts A, B, and C: Occurrence of dose-limiting toxicities (DLTs) within a participant per dose level/cohort.
2. 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.
3. All parts: Occurrence of dose interruptions, reductions, and discontinuation of BNT329 due to TEAEs per dose level/cohort.
4. 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.

Secondary endpoints 6

1. 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
2. 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.
3. 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.
4. 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.
5. 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).
6. All parts - ADA incidence per dose level/cohort. Defined as the proportion of participants having treatment-emergent ADA (if data permit).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

BioNTech SE

Sponsor organisation

BioNTech SE

Address

An Der Goldgrube 12, Oberstadt Oberstadt

City

Mainz

Postcode

55131

Country

Germany

Scientific contact point

Organisation

BioNTech SE

Contact name

Clinical Trial Information Desk

Public contact point

Organisation

BioNTech SE

Contact name

Clinical Trial Information Desk

Third parties 9

Locations

2 EU/EEA countries · 7 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 14 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications