Testing a new drug, IMP1734, for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety, tolerability, and preliminary efficacy of IMP1734, a PARP1 selective inhibitor, in patients with recurrent advanced solid tumors, including breast cancer, ovarian cancer, and metastatic castrate-resistant prostate cancer (mCRPC). The study is divided into three parts: dose escalation to determine the maximum tolerated dose, dose optimization to assess pharmacokinetics and anti-tumor activity, and dose expansion to evaluate the recommended dose in specific patient populations with deleterious mutations in homologous recombination repair genes. Participants will receive IMP1734 as a monotherapy.

Why it matters

Who can join: the full rules

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

Where it's running

• The University of Arizona Cancer Center
  Tucson, Arizona, United States Recruiting
• University of Arkansas Winthrop P. Rockefeller Cancer Institute
  Little Rock, Arkansas, United States Recruiting
• Sarah Cannon Research Institute Health One
  Denver, Colorado, United States Recruiting
• Smilow Cancer Hospital at Yale New Haven
  New Haven, Connecticut, United States Recruiting
• Advent Health Research Institute
  Celebration, Florida, United States Recruiting
• Sylvester Comprehensive Cancer Center
  Miami, Florida, United States Recruiting

+7 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Nicola Lynch
• Email: parpitrial@eikontx.com
• Phone: 212-540-4923

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.