RECRUITING

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

Talk to us

Conditions

Advanced Solid Tumor

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A First-in-human, Phase 1/2, Open-label, Multi-center, Dose-escalation, Dose-optimization, and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of PARP1 Selective Inhibitor, IMP1734, as Monotherapy in Patients With Advanced Solid Tumors

Quick Facts

Study Start:2023-12-11
Study Completion:2026-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06253130

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 89 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Any investigational or approved anti-cancer therapies administered within 28 days/ before the first dose of IMP1734
  2. * Have received prior PARP1 selective inhibitors
  3. * Mean resting QTcF \> 470 ms or QTcF \< 340 ms
  4. * Active or untreated central nervous system (CNS) metastases and/or carcinomatous meningitis.
  5. * Infections
  6. * Any known predisposition to bleeding
  7. * Unable to swallow oral medications OR have malabsorption syndrome or any other uncontrolled gastrointestinal condition that might impair the bioavailability

Contacts and Locations

Study Contact

Caroline Taromino
CONTACT
(341) 777-0566
parpitrial@eikontx.com

Principal Investigator

Viola Chen, MD
STUDY_DIRECTOR
Eikon Therapeutics

Study Locations (Sites)

University California Irvine
Irvine, California, 92868
United States
University of California San Francisco (UCSF)
San Francisco, California, 94158
United States
Sarah Cannon Research Institute Health One
Denver, Colorado, 80218
United States
Smilow Cancer Hospital at Yale New Haven
New Haven, Connecticut, 06511
United States
Advent Health Research Institute
Celebration, Florida, 34747
United States
Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
Washington University - Siteman Cancer Center
Saint Louis, Missouri, 63110
United States
Cayuga Medical Center
Ithaca, New York, 14850
United States
Medical University of South Carolina (MUSC) - Hollings CC
Charleston, South Carolina, 29425
United States
Sarah Cannon Research Institue Oncology
Nashville, Tennessee, 37203
United States
START - South Texas Accelerated Research Therapeutics
San Antonio, Texas, 78229
United States
START Mountain Region
West Valley City, Utah, 84119
United States

Collaborators and Investigators

Sponsor: Eikon Therapeutics

  • Viola Chen, MD, STUDY_DIRECTOR, Eikon Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-11
Study Completion Date2026-12-01

Study Record Updates

Study Start Date2023-12-11
Study Completion Date2026-12-01

Terms related to this study

Additional Relevant MeSH Terms

  • Advanced Solid Tumor