ClinicaliQ Trial Snapshot
- 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 • Phase I • Oncology • NCT07186842.
- What is being tested: BNT329, an investigational drug designed to target CA19-9-expressing advanced solid tumors, with primary focus on establishing safety profile and optimal dosing through adverse event monitoring.
- Patient eligibility overview: Adults with advanced solid tumors confirmed to express the CA19-9 tumor marker, meeting performance status and organ function criteria for investigational drug tolerance.
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- Quick orientation before opening the registry record.
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What This Trial Is Studying
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…
Eligibility Snapshot
- Key Inclusion Criteria All participants and parts: * Have an ECOG PS of 0 to 1 * 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 (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…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.