Recruiting
Phase 1

BNT317

Sponsor:

BioNTech SE

Code:

NCT06750185

Conditions

Advanced Solid Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BNT317 DL1

BNT317 DL2

BNT317 DL3

BNT317 DL4

BNT317 DL5 (intermediate)

Study Details

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.

Conditions

Advanced Solid Tumor

Study ID

NCT06750185

Start date

Jan 13, 2025

Status verified date

Feb, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

  • 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.

Key Exclusion Criteria:

  • 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.
  • 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).

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Enrollment

39 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: BNT317 DL1

BNT317 monotherapy

experimental: BNT317 DL2

BNT317 monotherapy

experimental: BNT317 DL3

BNT317 monotherapy

experimental: BNT317 DL4

BNT317 monotherapy

experimental: BNT317 DL5 (optional, intermediate)

BNT317 monotherapy

experimental: BNT317 DL6 (optional, intermediate)

BNT317 monotherapy

experimental: BNT317 DL7 (optional, additional)

BNT317 monotherapy

Interventions

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

Primary outcome measure

  • Occurrence of DLTs [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: from first IMP administration up to 14 days after the last dose of IMP ]
  • MTD or the recommended phase two dose (RP2D) of BNT317 [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

BioNTech clinical trials patient information

+49 6131 9084patients@biontech.de

Locations

Norton Cancer Institute PARENT

Recruiting

Louisville, Kentucky, United States, 40202

START Midwest

Recruiting

Grand Rapids, Michigan, United States, 49546

Carolina BioOncology Institute, LLC

Recruiting

Huntersville, North Carolina, United States, 28078

Rhode Island Hospital

Recruiting

East Providence, Rhode Island, United States, 02903

MUSC Hollings Cancer Center

Recruiting

Charleston, South Carolina, United States, 29425

Mary Crowley Cancer Research

Recruiting

Dallas, Texas, United States, 75230

South Texas Accelerated Research Therapeutics (START), LLC

Recruiting

San Antonio, Texas, United States, 78229

More Information

Sponsor

BioNTech SE

Last update posted

Feb 11, 2026

Last verified

Feb, 2026

Keywords

  • Malignant solid tumors
  • Immunotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by BioNTech SE on 2026-02-11.