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A First-in-human Study of PARP1 Selective Inhibitor, IMP1734, in Participants With Advanced Solid Tumors

RECRUITINGPhase 1/2Sponsored by Eikon Therapeutics
Actively Recruiting
PhasePhase 1/2
SponsorEikon Therapeutics
Started2023-12-11
Est. completion2026-02-01
Eligibility
Age18 Years – 89 Years
Healthy vol.Accepted
Locations23 sites
View on ClinicalTrials.gov →

NCT06253130

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.

Eligibility

Age: 18 Years – 89 YearsHealthy volunteers accepted
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 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

Conditions2

Advanced Solid TumorCancer

Locations23 sites

The University of Arizona Cancer Center
Tucson, Arizona, 85719
University of Arkansas Winthrop P. Rockefeller Cancer Institute
Little Rock, Arkansas, 72205
Hoag Health Center Irvine
Irvine, California, 92618
University California Irvine
Irvine, California, 92868
Sharp Memorial Hospital
San Diego, California, 92123

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