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
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
245 (estimated)
Sponsor
BioNTech SE · Industry
Who this trial is looking for
This trial is looking for people with advanced solid tumors that have a specific tumor marker called CA19-9. Participants will take the drug BNT329 and be monitored for side effects and how well the drug works over time.
Are You a Good Fit for This Trial?
You may be able to join if
I have a performance score of 0 to 1
I have measurable disease
I have a life expectancy of at least 3 months
I have a specific type of advanced cancer that expresses CA19-9
I have received all available standard therapies and they did not work
I have been offered all available standard therapies including targeted ones
I have radiographic disease progression with no effective treatment options
You may not be able to join if
I am enrolled in another investigational study
I have had recent anticancer treatment that did not have enough time before starting the trial
I have taken systemic steroids or immunosuppressive therapy recently
I have received a live vaccine in the last 4 weeks
I have active brain metastases or spinal cord compression
I have a history of certain lung conditions requiring steroids
I have active gastrointestinal conditions that may cause bleeding
I have an active infection requiring treatment
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 t…
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.
Trial Locations
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Status
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 e…
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.
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