First-in Human Phase I Study of ISM3091 in Patients With Advanced Solid Tumors

Inclusion Criteria: Patient should understand, sign, and date the written informed consent form (ICF) prior to screening Male or female aged 18 years or older Patients with for histologically confirmed locally advanced/metastatic breast cancer, ovarian cancer, prostate cancer who relapsed, progressed, or were intolerant to standard therapy, have no therapy with a known overall survival benefit exists or are not a candidate for these therapies Eastern Cooperative Oncology Group performance status 0, 1, or 2 Life expectancy ≥ 3 months Adequate bone marrow and organ function at study entry Exclusion Criteria: Prior treatment with a ubiquitin specific peptidase 1 (USP1) inhibitor Active infection with human immunodeficiency virus (HIV) or hepatitis B virus or hepatitis C virus Any unresolved toxicities from prior therapy greater than NCI-CTCAE version 5.0 Grade 1 or that have not resolved to baseline at the time of starting study. Exceptions include alopecia, peripheral neuropathy, and, upon discussion with and approval by the medical monitor, other toxicities that are not thought to present a risk to patient safety 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 Patient inability or unwillingness to comply with requirement for oral drug administration or presence of a gastrointestinal condition