A First-in-human Study of PARP1 Selective Inhibitor, IMP1734, in Participants With Advanced Solid Tumors
Purpose
This study investigates the safety and tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of EIK1003 in participants with advanced solid tumors.
Condition
- Advanced Solid Tumor
Eligibility
- Eligible Ages
- Between 18 Years and 89 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
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
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Cohort 1 |
IMP1734 monotherapy; oral tablet(s) daily (except for the single-dose period). The maximum trial duration is 3 years after the last participant's first treatment in the trial. |
|
Recruiting Locations
The University of Arizona Cancer Center
Tucson, Arizona 85719
Tucson, Arizona 85719
University of Arkansas Winthrop P. Rockefeller Cancer Institute
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
Hoag Health Center Irvine
Irvine, California 92618
Irvine, California 92618
Sarah Cannon Research Institute Health One
Denver, Colorado 80218
Denver, Colorado 80218
Smilow Cancer Hospital at Yale New Haven
New Haven, Connecticut 06511
New Haven, Connecticut 06511
Advent Health Research Institute
Celebration, Florida 34747
Celebration, Florida 34747
Sylvester Comprehensive Cancer Center
Miami, Florida 33136
Miami, Florida 33136
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
Karmanos Cancer Institute
Detroit, Michigan 48201
Detroit, Michigan 48201
Henry Ford Health
Detroit, Michigan 48202
Detroit, Michigan 48202
University of Minnesota-Clinical Research Unit
Minneapolis, Minnesota 55455
Minneapolis, Minnesota 55455
Lifespan Cancer Institute
Providence, Rhode Island 02903
Providence, Rhode Island 02903
Medical University of South Carolina (MUSC) - Hollings CC
Charleston, South Carolina 29425
Charleston, South Carolina 29425
West Cancer Center & Research Institute
Germantown, Tennessee 38138
Germantown, Tennessee 38138
Sarah Cannon Research Institue Oncology
Nashville, Tennessee 37203
Nashville, Tennessee 37203
More Details
- NCT ID
- NCT06253130
- Status
- Recruiting
- Sponsor
- Eikon Therapeutics
Detailed Description
This study will evaluate the safety, tolerability and preliminary efficacy of IMP1734 as monotherapy in patients with recurrent, advanced/metastatic solid tumors. This study includes 2 parts: Part 1 and Part 2. Part 1 includes a monotherapy dose escalation of EIK1003 followed by combination dose escalations in metastatic prostate cancer (mPC), ovarian and breast cancer. Part 1, dose escalation, the study will identify the maximum tolerated dose (MTD) or maximum achievable dose (MAD) in solid tumor. Part 2 will explore dose optimization with selection of an optimal dose for future clinical development of EIK1003.