BNT329 for Advanced Solid Tumors with CA19-9
This clinical trial is testing a drug called BNT329 for people with advanced solid tumors that have a specific marker called CA19-9. The main goals are to see if BNT329 is safe, find the best dose, and understand its side effects. Researchers will also look at how well BNT329 works by measuring if tumors shrink or stop growing. The study is open to adults aged 18 and older who have certain advanced solid tumors, such as pancreatic, bile duct, bladder, colorectal, or ovarian cancer, that haven't responded well to previous treatments. You must also have a good general health status and a life expectancy of at least 3 months. BNT329 is a monoclonal antibody, which is a type of protein designed to target specific cells.
- Study design
- This is an interventional study with a planned enrollment of 245 participants. It will involve different parts to investigate the safety and tolerability of BNT329.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for treatment-emergent adverse events (side effects) from the first dose of BNT329 until 60 days after the last dose, which could be up to 26 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07186842
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
Recruiting
PHASE1Ages 18+InterventionalTreatmentBioNTech SE
~245 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:BNT329CA19-9-targeting monoclonal antibody
At a glance
Recruiting sites
17 of 17 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Parts A and B - Occurrence of dose-limiting toxicities within a participant
Measured over First 21 days (Part A) or 28 days (Part B) after the first dose of BNT329.
+3 more outcomes measured
Conditions
Where it's being run
17 sites across 7 statesUnited Kingdom5
Spain4
Germany3
Australia2
Colorado1
Florida1
New York1
Study leadership
- BioNTech Response Person · STUDY_DIRECTOR · BioNTech SE
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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.
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.
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.
Exclusion
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.
What this trial measures
- Parts A and B - Occurrence of dose-limiting toxicities within a participantFirst 21 days (Part A) or 28 days (Part B) after the first dose of BNT329.
Per dose level.
- 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 SAEsFrom first dose of BNT329 until 60 days after the last dose of BNT329 (up to 26 months).
Per dose level.
- Parts A, B, and D - Occurrence of dose interruptions, reductions, and discontinuation of BNT329 due to TEAEsFrom the time of initiation of the first dose of BNT329 until 60 days after the last dose of BNT329 (up to 26 months).
Per dose level.
- Part D - Objective response rate (ORR)From first dose of BNT329 until end of study (up to approximately 36 months).
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.