Study BT5528-100 in Patients With Advanced Solid Tumors Associated With EphA2 Expression

General Inclusion:

• Written informed consent, according to local guidelines, signed and dated by the patient or by a legal guardian prior to the performance of any study-specific procedures, sampling or analyses
• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
• Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
• Acceptable renal, hepatic, hematologic and coagulation functions
• Negative pregnancy test for women of childbearing potential
• Male participants with female partners of childbearing potential and female participants of childbearing potential are required to follow highly effective contraception
• Availability of archived tumor samples or willingness to provide fresh tumor biopsy during screening

Additional inclusion criteria for Phase I (dose escalation phase, with BT5528 alone or in combination with nivolumab):

• Have advanced, histologically confirmed malignant solid tumors historically known for high expression of EphA2 that recurred after previous therapy and are candidates for a Phase I study due to lack of approved or standard options for treatment

Additional inclusion criteria for Phase II (dose expansion phase, with BT5528 alone or in combination with nivolumab):

• Participants with metastatic recurrent disease histologically confirmed to be adenocarcinoma subtype of NSCLC (adeno-NSCLC) are eligible and must have exhausted all standard treatment options including progression on or after platinum-based chemotherapy

Exclusion criteria (all participants):

• Chemotherapy treatments within 14 days prior to first dose of study treatment, other anticancer treatments, treatment within 28 days or 5 half-lives, whichever is the shorter
• Experimental treatments within 4 weeks of first dose of BT5528
• Current treatment with strong inhibitors or inducers of CYP3A4 or strong inhibitors of P-gp
• Uncontrolled, symptomatic brain metastases
• Any condition, therapy or laboratory abnormality that might confound the results of the study, interfere with the patient's participation, or is not in the best interest of the patient to participate in the opinion of the investigator including but not limited to specific cardiovascular criteria
• Thromboembolic events and/or bleeding disorders 3 months (e.g., deep vein thrombosis [DVT] or pulmonary embolism [PE]) prior to first dose

Additional Exclusion Criteria (BT5528 in combination with nivolumab):

• Prior organ transplant (including allogeneic)
• Diagnosis of clinically relevant immunodeficiency
• Active systemic infection requiring therapy
• More than 10 mg daily prednisone equivalent or other strong immunosuppressant
• History of autoimmune disease except alopecia or vitiligo
• History of interstitial lung disease