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

This study is testing a new therapy for people with advanced solid tumors to see if it's safe and how well it works at different doses.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 39 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: BioNTech SE (industry)
• Drugs / interventions: chemotherapy, immunotherapy, Radiation, prednisone
• Locations: 11 sites (Louisville, Kentucky and 10 other locations)
• Trial ID: NCT06750185 on ClinicalTrials.gov

What this trial studies

This is a first-in-human, open-label, multi-site, dose escalation study evaluating the safety, tolerability, pharmacokinetics, and immunogenicity of BNT317 in patients with advanced solid tumors. Participants will be assigned to one of four dose levels and may receive treatment for up to two years or until disease progression or unacceptable side effects occur. The study employs an accelerated titration design for the initial dose level and a Bayesian Optimal Interval design for subsequent levels to determine the maximum tolerated dose.

Who should consider this trial

Good fit: Ideal candidates are patients with histologically or cytologically confirmed advanced tumors who have failed standard therapy or have no appropriate treatment options available.

Not a fit: Patients who have received prior treatments that inhibit CD39 or have certain measurable lesions may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a new treatment option for patients with advanced solid tumors who have exhausted standard therapies.

How similar studies have performed: Other studies using similar immunotherapy approaches have shown promise, but this specific therapy is novel.

Eligibility criteria

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.

Where this trial is running

Louisville, Kentucky and 10 other locations

• Norton Cancer Institute PARENT — Louisville, Kentucky, United States (RECRUITING)
• START Midwest — Grand Rapids, Michigan, United States (RECRUITING)
• Carolina BioOncology Institute, LLC — Huntersville, North Carolina, United States (RECRUITING)
• Rhode Island Hospital — East Providence, Rhode Island, United States (RECRUITING)
• MUSC Hollings Cancer Center — Charleston, South Carolina, United States (RECRUITING)
• Mary Crowley Cancer Research — Dallas, Texas, United States (RECRUITING)
• South Texas Accelerated Research Therapeutics (START), LLC — San Antonio, Texas, United States (RECRUITING)
• Tasman Oncology Research Ltd — Southport, Queensland, Australia (RECRUITING)
• Cancer Research SA — Adelaide, Australia (RECRUITING)
• Monash Medical Centre Clayton — Clayton, Australia (RECRUITING)
• Scientia Clinical Research — Randwick, Australia (RECRUITING)

Study contacts

• Study coordinator: BioNTech clinical trials patient information

Conditions: Advanced Solid Tumor, Malignant solid tumors, Immunotherapy