A Phase 1/2, Open-Label, Multicenter, Dose-Escalation, and Dose-Optimization Study to Evaluate the Safety, Tolerability, and Activity of EIK1004 (IMP1707) as Monotherapy in Participants with Advanced Solid Tumors.
Primary:
- To evaluate the safety and tolerability of EIK1004 as monotherapy to determine the MTD (or MAD) and RDE as monotherapy (Part 1).
- To evaluate the safety and tolerability ofEIK1004 as monotherapy (Part 2).
Secondary:
- To characterize the plasma pharmacokinetic (PK) profile of single and multiple doses of EIK1004 (Part 1 and Part 2).
- To assess preliminary antitumor activity* of EIK1004 as monotherapy (Part 1).
- To assess preliminary antitumor activity of EIK1004 as monotherapy (Part 2).
- Rutgers University
• 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; Pancreatic cancer, must have prior 1L therapy - 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 EIK1004 (IMP1707) - Deleterious or suspected deleterious germline or somatic mutations of select HRR genes - Up to 1 prior line of PARP inhibitor containing treatment CNS Inclusion Criteria: - Untreated CNS metastases (measurable and/or non-measurable) not needing immediate local therapy. - Previously treated CNS metastases Key Exclusion Criteria: - Any investigational or approved anti-cancer therapies administered within 28 days/ before the first dose of EIK1004 (IMP1707) - Have received prior PARP1 selective inhibitors - Mean resting QTcF > 470 ms or QTcF < 340 ms - 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 CNS Exclusion Criteria - Any untreated brain lesions > 2.0 cm in size. - Ongoing use of systemic corticosteroids for control of symptoms of CNS metastases < 7 days prior to the first dose of study treatment or requirement for > 10 mg prednisone/day. - Any brain lesion requiring immediate local therapy, including (but not limited to) a lesion in an anatomic site where an increase in size or possible treatment-related edema may pose risk to the participant (eg, brain stem lesions). - Known, symptomatic leptomeningeal disease. - Have poorly controlled seizures.
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
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