Testing BNT329 for people with advanced solid tumors that express CA19-9.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1/2, multi-part study starts with dose-escalation cohorts (Parts A–C) to find a safe and tolerable dose of the antibody–drug conjugate BNT329, including exploration of a more frequent dosing schedule and pre-dosing with a CA19-9–targeting antibody. Part D will randomize participants with second-line-or-later pancreatic ductal adenocarcinoma to compare two dose levels chosen from earlier parts to gather preliminary evidence of anti-tumor activity. Key outcomes include rates and severity of side effects, objective tumor responses, progression-free duration, and pharmacokinetics/pharmacodynamics of BNT329. Enrollment focuses on patients with advanced, CA19-9–expressing solid tumors who have limited standard therapy options.

Why it matters

Who can join: the full rules

Key Inclusion Criteria

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:

* 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.

Key Exclusion Criteria

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).
  * 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.

Where it's running

• SCRI at HCA Health One
  Denver, Colorado, United States Recruiting
• Florida Cancer Specialists
  Orlando, Florida, United States Recruiting
• Karmanos Cancer Institute
  Detroit, Michigan, United States Recruiting
• Memorial Sloan Kettering Cancer Center
  New York, New York, United States Recruiting
• Monash Health
  Clayton, Australia Recruiting
• Austin Health
  Heidelberg, Australia Recruiting

Study contacts

• Study coordinator: BioNTech clinical trials patient information
• Email: patients@biontech.de
• Phone: +49 6131 9084

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.