RecruitingPhase 1 / Phase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety and best dose of BNT329, an experimental drug, for people with certain advanced solid cancers known to make a marker called CA19-9. It also checks whether the drug helps control cancer and how it moves through and affects the body.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be fully active or able to walk and do light work, even if heavy activity is limited.
  • Have cancer that can be measured using the study’s rules. Ovarian cancer has different rules.
  • Be expected by the study doctor to live at least 3 months.
  • Have organs, blood cells, and blood clotting that work well enough under the study’s rules.
  • For Parts A–C: Have a tissue test confirming an advanced or spreading cancer type known to make CA19-9. Listed types include certain cancers of the pancreas, bile ducts, bladder or urinary tract, colon or rectum, stomach or where it joins the food pipe, uterus lining, ovaries, fallopian tubes, or belly lining. Mesothelioma is not included.
  • For Parts A–C: Have received all available standard treatments, including treatments aimed at gene changes. At least the first standard treatment must have failed, and no standard treatment is expected to help.
  • For Part D: Have a tissue test confirming pancreatic ductal adenocarcinoma, a type of pancreatic cancer. Scans must show that it is getting worse, and no standard treatment is expected to help.
  • For Part D: Have been offered all available standard treatments, including treatments aimed at gene changes. Available standard second treatments must not be withheld.

Who can't join

  • Be in another experimental study or still in its required waiting period; have too little time since prior cancer treatment; or have side effects from prior treatment that have not cleared enough.
  • Have used steroids affecting the whole body above 10 mg of prednisone daily, or an equal dose, or other medicines that weaken immune defenses within 2 weeks before treatment. Some inhaled, skin, injected, hormone-replacement, or allergy-prevention steroids are allowed.
  • Have received a live vaccine within 4 weeks before treatment, or plan to receive one during the study.
  • Have cancer that has spread to the brain or pressure on the spinal cord, unless there are no symptoms or it has been treated and is stable without steroids or seizure medicines for at least 2 weeks before treatment.
  • Have current or suspected lung inflammation called ILD or pneumonitis, or a history of noninfectious lung inflammation that needed steroids.
  • Have active stomach or upper-intestine ulcers, ulcerative colitis, or other gut problems that the doctor thinks could cause bleeding or a hole in the gut.
  • Have an active infection needing medicine that works throughout the body within 1 week before treatment. Medicines used to prevent infections may be allowed after discussion with the study sponsor.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (4)

CO

FL

MI

NY