A first-in-human, Phase 1/2, open-label, multi-center, dose-escalation, dose-optimization, and dose-expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of PARP1 selective inhibitor, IMP1734, as monotherapy and in combination in participants with advanced solid tumors
Eligibility: Inclusion Criteria
• Key Inclusion Criteria
• * Breast cancer; must have received at least one prior chemotherapy in neoadjuvant/adjuvant/metastatic setting, must have received hormonal therapy if HR+,
• * HGSOC or high grade endometrioid EOC, fallopian tube or primary peritoneal cancer; must have received at least one prior platinum-based chemotherapy for advanced disease
• * mCRPC with ongoing ADT, must have received NHA and up to 1 prior line of taxane chemotherapy
• * Age >= 18 years at the time of informed consent
• * Eastern Cooperative Oncology Group (ECOG) performance status =1
• * Adequate organ function
• * Life expectancy >= 12 weeks
• * Should have evaluable disease as defined by RECIST1.1 and/or CA125 or PSA
• * Female subjects of childbearing potential and male subjects must agree to use an effective method of contraception from study entry up to 6 months after the last dose of IMP1734
• * deleterious or suspected deleterious germline or somatic mutations of select HRR genes
• * up to 1 prior line of PARP inhibitor containing treatment
• Key
Exclusion Criteria
• * Any investigational or approved anti-cancer therapies administered within 28 days/ before the first dose of IMP1734
• * Have received prior PARP1 selective inhibitors
• * Mean resting QTcF > 470 ms or QTcF 340 ms
• * Active or untreated central nervous system (CNS) metastases and/or carcinomatous meningitis.
• * Infections
• - An active hepatitis B/C infection
• * Any known predisposition to bleeding
• * Unable to swallow oral medications OR have malabsorption syndrome or any other uncontrolled gastrointestinal condition that might impair the bioavailability