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A First-in-human Study of PARP1 Selective Inhibitor, IMP1734, in Participants With Advanced Solid Tumors
Trial Status: active
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.
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
Additional locations may be listed on ClinicalTrials.gov for NCT06253130.
Locations matching your search criteria
United States
Arizona
Tucson
Banner University Medical Center - Tucson
Status: Active
Name Not Available
California
Orange
UC Irvine Health/Chao Family Comprehensive Cancer Center
Status: Active
Name Not Available
Connecticut
New Haven
Yale University
Status: Active
Name Not Available
Trumbull
Smilow Cancer Hospital Care Center-Trumbull
Status: Active
Name Not Available
Florida
Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: Active
Name Not Available
Michigan
Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: Active
Name Not Available
Detroit
Wayne State University/Karmanos Cancer Institute
Status: Active
Name Not Available
Minnesota
Minneapolis
University of Minnesota/Masonic Cancer Center
Status: Active
Name Not Available
Missouri
Saint Louis
Siteman Cancer Center at Washington University
Status: Active
Name Not Available
New Jersey
Hackensack
Hackensack University Medical Center
Status: Active
Name Not Available
South Carolina
Charleston
Medical University of South Carolina
Status: Active
Name Not Available
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