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About
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.
Enrollment
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Volunteers
Inclusion and exclusion criteria
Key Inclusion Criteria
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
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
Primary purpose
Allocation
Interventional model
Masking
70 participants in 1 patient group
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Central trial contact
Caroline Taromino
Data sourced from clinicaltrials.gov
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