A study investigating a new drug (BNT317) and the safety of increasing doses in participants with advanced solid cancers.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

Exclusion

• Have received any of the following therapies or drugs within the noted time intervals prior to trial 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.
  • Broad-spectrum intravenous antibiotics therapy within 2 weeks prior to the first dose of IMP.
  • Any investigational product within 4 weeks before the first dose of IMP in this trial or ongoing participation in the active treatment phase of another interventional clinical trial.
  • Systemic cytotoxic chemotherapy, immunotherapy within 4 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 a single area of 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 trial.
  • Participants with known leptomeningeal metastases.
• Have uncontrolled hypertension or poorly controlled diabetes.
• 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. Patients 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.