Advanced Solid CancersPhase 1/2NCT07186842
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
A Phase 1/2 study testing BNT329 and CA19-9-targeting monoclonal antibody in people with Advanced Solid Cancers, run by BioNTech SE at 18 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Cancers
- What is being tested?
- BNT329 and CA19-9-targeting monoclonal antibody
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 245 participants
- Where
- 18 sitesin 5 countries
- Study dates
- 18 Nov 2025to May 2030
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 12Show fewer
- 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.
Who cannot join
- 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).
Show all 14Show fewer
- 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.
Trial locations and contacts
18 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
18 sites in 5 countries
United Kingdom5 sites, 5 recruiting
- Recruiting
St James´s University Hospital
Leeds, LS9 7TF
- Recruiting
Royal Free Hospital
London, NW3 2QG
- Recruiting
The Christie NHS Foundation Trust
Manchester, M20 4BX
- Recruiting
Northern Centre for Cancer Research
Newcastle upon Tyne, NE7 7DN
- Recruiting
The Royal Marsden Hospital
Sutton, SM2 5PT
United States4 sites, 4 recruiting
- Recruiting
SCRI at HCA Health One
Denver, Colorado, 80218
- Recruiting
Karmanos Cancer Institute
Detroit, Michigan, 48201
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
- Recruiting
Florida Cancer Specialists
Orlando, Florida, 32827
Spain4 sites, 4 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
- Recruiting
Hospital San Pedro
Logroño, 26006
- Recruiting
Hospital Universitario HM Sanchinarro - START Madrid CIOCC
Madrid, 28050
- Recruiting
Hospital Universitario Quironsalud Madrid - NEXT Oncology
Pozuelo de Alarcón, 28223
Germany3 sites, 3 recruiting
- Recruiting
St. Josef-Hospital im Katholischen Klinikum Bochum
Bochum, 44791
- Recruiting
Klinikum der Universität München
München, 81377
- Recruiting
Universitaetsklinikum Ulm
Ulm, D-89081
Australia2 sites, 2 recruiting
- Recruiting
Monash Health
Clayton, 3168
- Recruiting
Austin Health
Heidelberg, 3084
About this study
Official title: First-in-human, Open-label, Multi-site, Phase I/IIa, Dose Escalation Trial With Expansion Cohorts to Evaluate Safety and Preliminary Efficacy of BNT329 in Participants With Advanced Solid Tumors Known to Express CA19-9
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.
Read the detailed description
The study will consist of up to four parts (Parts A, B, C, and D).
Parts A and B will be a dose escalation to investigate the safety and tolerability of BNT329. Parts A and B will enroll participants with the following advanced solid tumors known to express carbohydrate antigen 19-9 (CA19-9): pancreatic ductal adenocarcinoma (PDAC) (the most common type of pancreatic cancer), bile duct cancer, a certain type of bladder cancer that started in the lining of the bladder or urinary tract (invasive urothelial carcinoma of the bladder and urinary tract), colorectal cancer, gastroesophageal junction cancer, gastric adenocarcinoma, endometrial cancer, or ovarian cancer. The cancer must not have responded well to previous treatments.
The study will start with recruitment into Part A. Part B (testing a more frequent dosing schedule) will only be opened if indicated by cumulative data from Part A of the study.
Part C (testing pre-dosing with a CA19-9 targeting monoclonal antibody prior to BNT329 administration) will only be opened in case of unforeseen safety and/or weak efficacy signals are detected in Part A and (if opened) Part B. Details on Part C will be added in a future update, if it is necessary, to open this part.
Part D will be a dose optimization and proof-of-concept study to further investigate the safety and tolerability of BNT329 and to investigate preliminary anti-tumor activity. Part D will enroll participants with second-line plus PDAC.
Parts A, B, and C will be non-randomized. In Part D, participants will be randomized (1:1) into one of two arms which will evaluate two dose levels (as selected from Parts A and B).
The study consists of a screening period, a treatment period, an end of treatment visit, two safety follow-up visits, and a survival follow-up period. The treatment period will last for a maximum of 2 years. Participants will remain in the survival follow-up until death, withdrawal of participant's consent, or termination of the study, whichever occurs first.
- Conditions
- Advanced Solid Cancers
- Being tested
- BNT329, CA19-9-targeting monoclonal antibody
- 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
- Medical subject headings
- Bile Duct Neoplasms, Colorectal Neoplasms, Endometrial Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BNT329Drug
Intravenous (IV) infusion
CA19-9-targeting monoclonal antibodyDrug
Monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation - Part A | Experimental | BNT329 administered once every 3 weeks at protocol-defined dose levels Receives: Drug: BNT329 |
| Dose Escalation - Part B | Experimental | BNT329 administered once every 2 weeks at protocol-defined dose levels Receives: Drug: BNT329 |
| Dose Escalation: Part C | Experimental | BNT329 administered after pre-dosing with a CA19-9 targeting monoclonal antibody Receives: 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/or C Receives: Drug: BNT329 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parts A and B - Occurrence of dose-limiting toxicities within a participant
Per dose level.
Measured: 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
Per dose level.
Measured: 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
Per dose level.
Measured: 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. 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.
Measured: From first dose of BNT329 until end of study (up to approximately 36 months).
Secondary outcomes (11)
Parts A, B, and D - Assessment of area under the curve derived from serum/plasma concentrations of CA19-9-unbound ADC, CA19-9-unbound total anti-CA19-9 antibody, and unconjugated YL0010014 payload
Per dose level (if data permit)
Measured: First 21 days (Part A) or 28 days (Part B) after the first dose of BNT329.
Parts A, B, and D - Assessment of maximum concentration derived from serum/plasma concentrations of CA19-9-unbound ADC, CA19-9-unbound total anti-CA19-9 antibody, and unconjugated YL0010014 payload
Per dose level (if data permit).
Measured: First 21 days (Part A) or 28 days (Part B) after the first dose of BNT329.
Parts A, B, and D - Assessment of time to reach maximum concentration derived from serum/plasma concentrations of CA19-9-unbound ADC, CA19-9-unbound total anti-CA19-9 antibody, and unconjugated YL0010014 payload
Per dose level (if data permit).
Measured: First 21 days (Part A) or 28 days (Part B) after the first dose of BNT329.
Parts A, B, and D - Assessment of terminal half-life derived from serum/plasma concentrations of CA19-9-unbound ADC, CA19-9-unbound total anti-CA19-9 antibody, and unconjugated YL0010014 payload
Per dose level (if data permit).
Measured: First 21 days (Part A) or 28 days (Part B) after the first dose of BNT329.
Parts A and B - ORR
Per dose level. Defined as the proportion of participants in whom a confirmed CR or PR (based on the investigator's assessment) is observed as best overall response.
Measured: From first dose of BNT329 until end of study (up to approximately 36 months).
Parts A, B, and D - Disease control rate
Per dose level. Defined as the proportion of participants in whom a CR or PR or stable disease (assessed at least 6 weeks [±2 days] after the first BNT329 dose) is observed as best overall response per investigator's assessment.
Measured: From first dose of BNT329 until end of study (up to approximately 36 months).
Parts A, B, and D - Duration of response
Per dose level. 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.
Measured: From first dose of BNT329 until end of study (up to approximately 36 months).
Parts A, B, and D - Progression free survival
Per dose level. Defined as the time from first dose of BNT329 to first objective tumor progression (PD per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v1.1] based on the investigator's assessment), or death from any cause, whichever occurs first.
Measured: From first dose of BNT329 until end of study (up to approximately 36 months).
Part D - Overall survival
Per dose level. Defined as the time from first dose of BNT329 to death from any cause.
Measured: From first dose of BNT329 until end of study (up to approximately 36 months).
Parts A, B, and D: 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).
Measured: From first dose of BNT329 until up to 60 days after the last dose of BNT329 (up to 26 months).
Parts A, B, and D - ADA incidence
Per dose level/cohort. Defined as the proportion of participants having treatment-emergent ADA (if data permit).
Measured: From first dose of BNT329 until up to 60 days after the last dose of BNT329 (up to 26 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start18 Nov 2025
- Primary completionMay 2030 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid CancersStudies of the same condition, open and under way.
- More trials run by BioNTech SEThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 245 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioNTech SE
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- BioNTech Response Person, Study director, BioNTech SE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07186842
- Sponsor's protocol ID
- BNT329-01
- Other IDs
- 2025-522613-26-00, 1012877, 2025
- Status last verified
- Oct 2026
- First submitted
- 16 Sep 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No