Safety and Preliminary Effectiveness of BNT317, an Investigational Therapy for Advanced Solid Tumors
NCT ID: NCT06750185
Last Updated: 2026-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
39 participants
INTERVENTIONAL
2025-01-13
2028-06-30
Brief Summary
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Detailed Description
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Participants may receive investigational medicinal product (IMP) for up to 2 years or until they experience disease progression, unacceptable toxicities, withdrawal of consent, study discontinuation or investigator decision. The total duration of the study for a singe participant may be up to 2 years, plus follow-up until the last participant has completed 1 year of survival follow-up (excluding screening).
In the dose escalation phase, an accelerated titration design for Dose Level 1 (DL1) and a Bayesian Optimal Interval (BOIN) design for DL2 to DL4 will be used to evaluate dose limiting toxicities (DLTs) and determine the maximum tolerated dose (MTD).
Additional dosing schedules and/or intermediate or higher dose levels may be evaluated based on the available safety, antitumor activity, PK, and pharmacodynamic (PD) data.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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BNT317 DL1
BNT317 monotherapy
BNT317 DL1
Intravenous infusion
BNT317 DL2
BNT317 monotherapy
BNT317 DL2
Intravenous infusion
BNT317 DL3
BNT317 monotherapy
BNT317 DL3
Intravenous infusion
BNT317 DL4
BNT317 monotherapy
BNT317 DL4
Intravenous infusion
BNT317 DL5 (optional, intermediate)
BNT317 monotherapy
BNT317 DL5 (intermediate)
Intravenous infusion
BNT317 DL6 (optional, intermediate)
BNT317 monotherapy
BNT317 DL6 (intermediate)
Intravenous infusion
BNT317 DL7 (optional, additional)
BNT317 monotherapy
BNT317 DL7 (additional)
Intravenous infusion
Interventions
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BNT317 DL1
Intravenous infusion
BNT317 DL2
Intravenous infusion
BNT317 DL3
Intravenous infusion
BNT317 DL4
Intravenous infusion
BNT317 DL5 (intermediate)
Intravenous infusion
BNT317 DL6 (intermediate)
Intravenous infusion
BNT317 DL7 (additional)
Intravenous infusion
Eligibility Criteria
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Inclusion Criteria
* Have at least one measurable lesion based on RECIST 1.1. Lesions treated after prior local treatment (radiotherapy, ablation, interventional procedures, etc.) are generally not considered as target lesions. If the lesion with prior local treatment is the only targeted lesion, evidence-based radiology must be provided to demonstrate disease progression (the single bone metastasis or the single central nervous system \[CNS\] metastasis should not be considered as a measurable lesion).
* Adequate hematologic and organ function.
Exclusion Criteria
* Any prior treatment which inhibits cluster of differentiation 39 (CD39).
* Vaccination with live attenuated vaccine(s) within 4 weeks prior to the first dose of IMP.
* Any investigational product within 4 weeks or 5 half lives (if the half life of the other investigational product is known), whichever is longer, before the first dose of IMP in this study or ongoing participation in the active treatment phase of another interventional clinical study.
* Systemic cytotoxic chemotherapy, immunotherapy within 3 weeks or five half-lives of the chemotherapy (whichever is shorter) prior to the first dose of IMP.
* Radiation therapy (chest, brain or internal organs) within 4 weeks prior to the first dose of IMP.
* Palliative radiotherapy to metastasis within 2 weeks prior to the first dose of IMP.
* Systemic corticosteroids (at a dosage greater than 10 mg/day of prednisone or an equivalent dose of other corticosteroids) within 2 weeks prior to the first dose of IMP. Note: local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short term use (≤7 days) of corticosteroids for prophylaxis (e.g., prevention of contrast agent allergy) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity reactions caused by exposure to allergens) is allowed.
* Have any of the following CNS metastases:
* Untreated brain metastases that are symptomatic or large (e.g., greater than 2 cm).
* Treated CNS metastases who are not neurologically stable or on steroids or anticonvulsants within 2 weeks before initiating IMP of this study.
* Brain metastases treated with radiotherapy that are not confirmed stable by magnetic resonance imaging or contrast-enhanced computer tomography 4 weeks after radiotherapy.
* Participants with known leptomeningeal metastases.
* Have uncontrolled hypertension or poorly controlled diabetes as specified in the protocol.
* Have a history of allogeneic hematopoietic stem cell transplantation or organ transplantation.
* Have a history of serious Grade ≥3 immune-related adverse events (irAEs) or irAEs that led to discontinuation of a prior immunotherapy. Participants with a history of Grade ≥3 irAEs that did not lead to discontinuation of a prior immunotherapy may be included at the discretion of the investigator. If required by the investigator, after consultation with the sponsor.
* Have uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently).
18 Years
ALL
No
Sponsors
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BioNTech SE
INDUSTRY
Responsible Party
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Principal Investigators
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BioNTech Responsible Person
Role: STUDY_DIRECTOR
BioNTech SE
Locations
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Norton Cancer Institute PARENT
Louisville, Kentucky, United States
START Midwest
Grand Rapids, Michigan, United States
Carolina BioOncology Institute, LLC
Huntersville, North Carolina, United States
Rhode Island Hospital
East Providence, Rhode Island, United States
MUSC Hollings Cancer Center
Charleston, South Carolina, United States
Mary Crowley Cancer Research
Dallas, Texas, United States
South Texas Accelerated Research Therapeutics (START), LLC
San Antonio, Texas, United States
Tasman Oncology Research Ltd
Southport, Queensland, Australia
Cancer Research SA
Adelaide, , Australia
Monash Medical Centre Clayton
Clayton, , Australia
Scientia Clinical Research
Randwick, , Australia
Countries
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Central Contacts
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Other Identifiers
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BNT317-01
Identifier Type: -
Identifier Source: org_study_id
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