Safety and Preliminary Effectiveness of BNT317, an Investigational Therapy for Advanced Solid Tumors

Key Inclusion Criteria:

• Have histologically or cytologically confirmed advanced tumors, who have failedstandard therapy, or for whom no standard treatment option is available, or for whomstandard therapy is not appropriate.

• Have at least one measurable lesion based on RECIST 1.1. Lesions treated after priorlocal treatment (radiotherapy, ablation, interventional procedures, etc.) aregenerally not considered as target lesions. If the lesion with prior local treatmentis the only targeted lesion, evidence-based radiology must be provided todemonstrate disease progression (the single bone metastasis or the single centralnervous 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 timeintervals 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 firstdose of IMP.

• Any investigational product within 4 weeks or 5 half lives (if the half life ofthe other investigational product is known), whichever is longer, before thefirst dose of IMP in this study or ongoing participation in the activetreatment phase of another interventional clinical study.

• Systemic cytotoxic chemotherapy, immunotherapy within 3 weeks or fivehalf-lives of the chemotherapy (whichever is shorter) prior to the first doseof IMP.

• Radiation therapy (chest, brain or internal organs) within 4 weeks prior to thefirst dose of IMP.

• Palliative radiotherapy to metastasis within 2 weeks prior to the first dose ofIMP.

• Systemic corticosteroids (at a dosage greater than 10 mg/day of prednisone oran equivalent dose of other corticosteroids) within 2 weeks prior to the firstdose of IMP. Note: local, intranasal, intraocular, intra-articular or inhaledcorticosteroids, short term use (≤7 days) of corticosteroids for prophylaxis (e.g., prevention of contrast agent allergy) or treatment of non-autoimmuneconditions (e.g., delayed hypersensitivity reactions caused by exposure toallergens) is allowed.

• Have any of the following CNS metastases:

• Untreated brain metastases that are symptomatic or large (e.g., greater than 2cm).

• Treated CNS metastases who are not neurologically stable or on steroids oranticonvulsants within 2 weeks before initiating IMP of this study.

• Brain metastases treated with radiotherapy that are not confirmed stable bymagnetic resonance imaging or contrast-enhanced computer tomography 4 weeksafter radiotherapy.

• Participants with known leptomeningeal metastases.

• Have uncontrolled hypertension or poorly controlled diabetes as specified in theprotocol.

• Have a history of allogeneic hematopoietic stem cell transplantation or organtransplantation.

• Have a history of serious Grade ≥3 immune-related adverse events (irAEs) or irAEsthat led to discontinuation of a prior immunotherapy. Participants with a history ofGrade ≥3 irAEs that did not lead to discontinuation of a prior immunotherapy may beincluded at the discretion of the investigator. If required by the investigator,after consultation with the sponsor.

• Have uncontrolled pleural effusion, pericardial effusion, or ascites requiringrecurrent drainage procedures (once monthly or more frequently).

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