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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
EU CTIS ID: 2025-522613-26-00
What this study is testing
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.
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
- 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
- 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.
- 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.
You likely can't join if
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
See the full eligibility criteria
Who can join
- 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.
- 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
- 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.
- 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.
What rules you out
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- All participants and parts: Have unresolved toxicities from previous anticancer therapy as defined in the protocol.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Australia
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Australia; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.