Overview
The primary purpose of this study is to determine the safety, tolerability, and maximum tolerated dose (MTD) of EXS74539 (REC-4539) in participants with select solid tumors.
Eligibility
Key Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Histologically confirmed diagnosis of the following solid tumors:
- SCLC
- High grade neuroendocrine or small cell carcinomas of non-lung origin
- Non-small cell lung cancer \[NSCLC\]
- Prostate cancer
- Ovarian cancer
- Renal carcinoma \[clear and non-clear cell\]
- Head and neck squamous cell carcinoma
- Hepatic cancer
- Gastric cancer
- Triple-negative breast cancer \[TNBC\]
- Participant disease should have progressed, relapsed or the participants should have been intolerant to at least one prior standard systemic therapy for their respective underlying malignancy.
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Key Exclusion Criteria:
- Any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the participant's safety or ability to participate in the study.
- Symptomatic brain metastases, leptomeningeal metastases, or spinal cord compression due to disease. Participants with brain metastases must be clinically stable and off corticosteroids and anticonvulsants for ≥1 month prior to study treatment and not require any specific intervention for brain metastases.
- Active and clinically significant infection requiring systemic antibacterial, antiviral, or antifungal therapy \<7 days of the first scheduled dose of the study treatment.
- Significant cardiac abnormalities.
- Major surgery within 28 days prior to the start of study treatment.
Note: Other protocol-defined inclusion and exclusion criteria may apply.