Ovarian Cancer Clinical Trial
A First-in-human Study of PARP1 Selective Inhibitor, IMP1734, in Participants With Advanced Solid Tumors
Summary
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.
Full 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.
Eligibility Criteria
Key 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 HHR 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
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There are 11 Locations for this study
Denver Colorado, 80218, United States More Info
Principal Investigator
Celebration Florida, 34747, United States More Info
Principal Investigator
Nashville Tennessee, 37203, United States More Info
Principal Investigator
San Antonio Texas, 78229, United States More Info
Principal Investigator
West Valley City Utah, 84119, United States More Info
Principal Investigator
Randwick New South Wales, 2031, Australia More Info
Principal Investigator
South Brisbane Queensland, 4101, Australia More Info
Principal Investigator
Southport Queensland, 4125, Australia More Info
Sydney Queensland, 2109, Australia More Info
Principal Investigator
Woolloongabba Queensland, 4102, Australia More Info
Frankston Victoria, 3199, Australia More Info
Principal Investigator
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