RecruitingPhase 1Phase 2NCT06253130
A First-in-human Study of PARP1 Selective Inhibitor, IMP1734, in Participants With Advanced Solid Tumors
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 in Patients With Advanced Solid Tumors
Sponsor
Eikon Therapeutics
Enrollment
156 participants
Start Date
Dec 11, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
This study investigates the safety and tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of EIK1003 in participants with advanced solid tumors.
Eligibility
Min Age: 18 YearsMax Age: 89 Years
Inclusion Criteria11
- 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
Exclusion Criteria8
- 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
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Interventions
DRUGIMP1734
PARP1 selective inhibitor
Locations(53)
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NCT06253130
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