Safety and Preliminary Effectiveness of BNT317, an Investigational Therapy for Advanced Solid Tumors
A Phase I, First-in-human, Open-label, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BNT317 in Patients With Advanced Solid Tumors
1 other identifier
interventional
39
2 countries
11
Brief Summary
This is a first-in-human (FIH), open-label, multiple-site, dose escalation study which will evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of increasing doses of BNT317 in participants with advanced solid tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jan 2025
Typical duration for phase_1
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 12, 2024
CompletedFirst Posted
Study publicly available on registry
December 27, 2024
CompletedStudy Start
First participant enrolled
January 13, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
February 11, 2026
February 1, 2026
3.4 years
December 12, 2024
February 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Occurrence of DLTs
Per dose group. During the DLT observation period.
up to 28 days post IMP administration on Day 1 of Cycle 1 or the day before Cycle 3 Day 1, whichever comes earlier (each cycle is 14 days)
Occurrence of treatment emergent adverse events (TEAEs) and treatment related adverse events (TRAEs)
Per dose group. Assessed according to (US National Cancer Institute) Common Terminology Criteria for Adverse Events version 5.0, including Grade ≥3, serious, fatal TEAE by relationship.
from first IMP administration up to 100 days after last dose of IMP or until a new anticancer therapy is initiated
Occurrence of dose interruption or discontinuation of study treatment due to TEAEs
Per dose group.
from first IMP administration up to 14 days after the last dose of IMP
MTD or the recommended phase two dose (RP2D) of BNT317
For MTD, up to 28 days post IMP administration on Cycle 1 Day 1 or the day before Cycle 3 Day 1, whichever comes earlier (each cycle is 14 days) or, for RP2D, up to 100 days
Secondary Outcomes (9)
Objective Response Rate (ORR)
from first IMP administration up to 100 days after last dose of IMP or until a new anticancer therapy is initiated
Duration of Response (DOR)
from first IMP administration up to 100 days after last dose of IMP or until a new anticancer therapy is initiated
Disease Control Rate (DCR)
from at least 6 weeks after the first IMP dose up to 100 days after last dose of IMP or until a new anticancer therapy is initiated
PK assessment: The maximum (peak) serum concentration (Cmax) of BNT317
from pre-dose Cycle 1 to pre-dose Cycle 4 (each cycle is 14 days)
PK assessment: Time to reach maximum (peak) serum concentration (Tmax) of BNT317
from pre-dose Cycle 1 to pre-dose Cycle 4 (each cycle is 14 days)
- +4 more secondary outcomes
Study Arms (7)
BNT317 DL1
EXPERIMENTALBNT317 monotherapy
BNT317 DL2
EXPERIMENTALBNT317 monotherapy
BNT317 DL3
EXPERIMENTALBNT317 monotherapy
BNT317 DL4
EXPERIMENTALBNT317 monotherapy
BNT317 DL5 (optional, intermediate)
EXPERIMENTALBNT317 monotherapy
BNT317 DL6 (optional, intermediate)
EXPERIMENTALBNT317 monotherapy
BNT317 DL7 (optional, additional)
EXPERIMENTALBNT317 monotherapy
Interventions
Eligibility Criteria
You may qualify if:
- Have histologically or cytologically confirmed advanced tumors, who have failed standard therapy, or for whom no standard treatment option is available, or for whom standard therapy is not appropriate.
- 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.
You may not qualify if:
- Have received any of the following therapies or drugs within the noted time intervals prior to study treatment:
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BioNTech SElead
Study Sites (11)
Norton Cancer Institute PARENT
Louisville, Kentucky, 40202, United States
START Midwest
Grand Rapids, Michigan, 49546, United States
Carolina BioOncology Institute, LLC
Huntersville, North Carolina, 28078, United States
Rhode Island Hospital
East Providence, Rhode Island, 02903, United States
MUSC Hollings Cancer Center
Charleston, South Carolina, 29425, United States
Mary Crowley Cancer Research
Dallas, Texas, 75230, United States
South Texas Accelerated Research Therapeutics (START), LLC
San Antonio, Texas, 78229, United States
Tasman Oncology Research Ltd
Southport, Queensland, 4215, Australia
Cancer Research SA
Adelaide, 5000, Australia
Monash Medical Centre Clayton
Clayton, 3168, Australia
Scientia Clinical Research
Randwick, 2031, Australia
Study Officials
- STUDY DIRECTOR
BioNTech Responsible Person
BioNTech SE
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2024
First Posted
December 27, 2024
Study Start
January 13, 2025
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
June 1, 2028
Last Updated
February 11, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share