A First-in-human Study of PARP1 Selective Inhibitor, IMP1734, in Participants With Advanced Solid Tumors
Purpose
This study will evaluate the preliminary efficacy of IMP1734 in patients with recurrent advanced/metastatic breast cancer, ovarian cancer and metastatic castrate resistant prostate cancer (mCRPC) with deleterious/suspected deleterious mutations of select homologous recombination repair (HRR) genes.
Condition
- Advanced Solid Tumor
Eligibility
- Eligible Ages
- Between 18 Years and 89 Years
- Eligible Genders
- 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
Irvine, California 92868
San Francisco, California 94158
Denver, Colorado 80218
New Haven, Connecticut 06511
Celebration, Florida 34747
Detroit, Michigan 48201
Saint Louis, Missouri 63110
Ithaca, New York 14850
Charleston, South Carolina 29425
Nashville, Tennessee 37203
San Antonio, Texas 78229
West Valley City, Utah 84119
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. The study consists of 3 parts: Dose escalation, Dose Optimization and Dose expansion. In dose escalation (Part1), the study will identify the maximum tolerated dose (MTD) or maximum achievable dose (MAD) in solid tumor. In dose optimization (Part 2), the study will further evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of select doses of IMP1734. In dose expansion (Part 3) the recommended dose escalation (RDE) of IMP1734 monotherapy will be evaluated in patients with recurrent, advanced/metastatic breast cancer, ovarian cancer and mCRPC with deleterious/suspected deleterious mutations of select homologous recombination repair (HRR) gene mutations.