A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Patients With Advanced Solid Tumors

Eligibility Criteria

• 1. Capable of understanding and complying with protocol requirements
• 2. Male or female aged 18 years or older
• 3. Eastern Cooperative Oncology Group performance status 0 or 1.
• 4. Adequate bone marrow and organ function
• 5. Subjects in the Cohort-Expansion Stage must have at least 1 measurable target lesion
• 6. Recovery to baseline or ≤ Grade 1 CTCAE v5 from AE(s) related to any prior treatments
• 1. Prior anticancer treatment including:
• 1. Chemotherapy or small molecule-targeted therapy \< 3 weeks prior to first dose of study treatment.
• 2. Any antibody therapy \< 5 half-lives from first dose of study treatment (or 4 weeks since last therapy, whichever is the shortest).
• 3. Chemotherapy with nitrosoureas or mitomycin C \< 6 weeks from first dose of study treatment.
• 4. Radiation therapy (including radiofrequency ablation) \< 1 week prior to initiation of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.
• 2. Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment
• 3. History of hypersensitivity to any excipient of XL309, or history of allergic reactions attributed to drugs with a similar chemical or biologic structure or class to XL309
• 4. Lactating or pregnant females.
• 5. Clinically relevant cardiovascular disease
• 6. Known history of myelodysplastic syndrome.
• 7. Other severe, acute, or chronic medical condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or that may interfere with the interpretation of the study results, and in the judgement of the investigator, would make the patient inappropriate for the study.
• 8. Inability or unwillingness to comply with requirement for oral drug administration or presence of a gastrointestinal condition that would preclude adequate absorption of XL309.