RECRUITING

A Study of PARP1 Selective Inhibitor, EIK1004 (IMP1707) in Participants With Advanced Solid Tumors.

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 safety, tolerability, and preliminary efficacy of EIK1004 (IMP1707) in participants with recurrent advanced/metastatic breast cancer, ovarian cancer, metastatic castrate resistant prostate cancer (mCRPC) and pancreatic cancer with deleterious/suspected deleterious mutations of select homologous recombination repair (HRR) genes. Condition or disease Intervention/treatment Phase Advanced Solid Tumors Drug: EIK1004 (IMP1707) Phase 1/Phase 2

Official Title

A Phase 1/2, Open-label, Multicenter, Dose-escalation, and Dose-Optimization Study to Evaluate the Safety, Tolerability, and Activity of EIK1004 (IMP1707) as Monotherapy in Participants With Advanced Solid Tumors

Quick Facts

Study Start:2025-05-12
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06907043

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. * Untreated CNS metastases (measurable and/or non-measurable) not needing immediate local therapy.
  2. * Previously treated CNS metastases
  1. * Any investigational or approved anti-cancer therapies administered within 28 days/ before the first dose of EIK1004 (IMP1707)
  2. * Have received prior PARP1 selective inhibitors
  3. * Mean resting QTcF \> 470 ms or QTcF \< 340 ms
  4. * Infections
  5. * Any known predisposition to bleeding
  6. * Unable to swallow oral medications OR have malabsorption syndrome or any other uncontrolled gastrointestinal condition that might impair the bioavailability
  7. * Any untreated brain lesions \> 2.0 cm in size.
  8. * Ongoing use of systemic corticosteroids for control of symptoms of CNS metastases \< 7 days prior to the first dose of study treatment or requirement for \> 10 mg prednisone/day.
  9. * Any brain lesion requiring immediate local therapy, including (but not limited to) a lesion in an anatomic site where an increase in size or possible treatment-related edema may pose risk to the participant (eg, brain stem lesions).
  10. * Known, symptomatic leptomeningeal disease.
  11. * Have poorly controlled seizures.

Contacts and Locations

Study Contact

Sunny Chaudry, MS
CONTACT
6319026200
chaudrys@eikontx.com

Principal Investigator

Yawei Zhang, MD
STUDY_DIRECTOR
Eikon Therapeutics

Study Locations (Sites)

MD Anderson
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Eikon Therapeutics

  • Yawei Zhang, 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 Date2025-05-12
Study Completion Date2028-12

Study Record Updates

Study Start Date2025-05-12
Study Completion Date2028-12

Terms related to this study

Keywords Provided by Researchers

  • EIK1004
  • IMP1707
  • Advanced/recurrent/metastatic pancreatic adenocarcinoma
  • Brain metastases
  • Advanced HER2-negative breast adenocarcinoma
  • Recurrent HER2-negative breast adenocarcinoma
  • metastatic HER2-negative breast adenocarcinoma

Additional Relevant MeSH Terms

  • Advanced Solid Tumors