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New treatment option for Advanced Solid Cancers
Official title 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
ClinicalTrials.gov ID: NCT07186842
What this study is testing
What is BNT329?
BNT329 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced solid cancers.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Key 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...
- 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:
You likely can't join if
- 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...
- Have received systemic steroids (\>10 mg/day of prednisone or its equivalent) or other immunosuppressive therapy within 2 weeks prior to the first...
- 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...
See the full eligibility criteria
- Key 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...
- 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...
- 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
- 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...
- Have unresolved toxicities from previous anticancer therapy as defined in the protocol. NOTE: Other protocol defined inclusion/exclusion criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- Denver, Colorado, United States
- Orlando, Florida, United States
- New York, New York, United States
- Clayton, Australia
- Heidelberg, Australia
- Bochum, Germany
- Ulm, Germany
- Barcelona, Spain
- Logroño, Spain
- Madrid, Spain
- Pozuelo de Alarcón, Spain
- Leeds, United Kingdom
- London, United Kingdom
- Manchester, United Kingdom
- Newcastle upon Tyne, United Kingdom
- Sutton, 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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Denver, Colorado, United States; Orlando, Florida, United States; New York, New York, United States; Clayton, Australia; Heidelberg, Australia; Bochum, Germany and 10 more location(s). 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 ClinicalTrials.gov; the study team decides eligibility.