A Phase 1, Multicenter, Open-Label, Dose-Escalation Study to Assess Safety, Tolerability, and Efficacy of EXS74539 as Monotherapy in Participants With Select Solid Tumors
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.
• 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.