Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06253130 | RECRUITING | Advanced Solid Tumor

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

Eikon Therapeutics

Brief 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.

Condition or disease

Advanced Solid Tumor

Intervention/treatment

IMP1734

Phase

PHASE1

PHASE2

Detailed 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 70 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2023-12-11
Estimated Primary Completion Date : 2026-02-01
Estimated Study Completion Date : 2026-12-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 89 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
    • A First-in-human Study of PARP1 Selective Inhibitor, IMP1734, in Participants With Advanced Solid Tumors

    Location Details

    NCT06253130

    Please Choose a site

    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations

    RECRUITING

    United States, California

    University California Irvine

    Irvine, California, United States, 92868

    RECRUITING

    United States, California

    University of California San Francisco (UCSF)

    San Francisco, California, United States, 94158

    RECRUITING

    United States, Colorado

    Sarah Cannon Research Institute Health One

    Denver, Colorado, United States, 80218

    RECRUITING

    United States, Connecticut

    Smilow Cancer Hospital at Yale New Haven

    New Haven, Connecticut, United States, 06511

    RECRUITING

    United States, Florida

    Advent Health Research Institute

    Celebration, Florida, United States, 34747

    RECRUITING

    United States, Road cancer

    Karmanos Cancer Institute

    Detroit, Road cancer, United States, 48201

    RECRUITING

    United States, Missouri

    Washington University - Siteman Cancer Center

    Saint Louis, Missouri, United States, 63110

    RECRUITING

    United States, New York

    Cayuga Medical Center

    ITHACA, New York, United States, 14850

    RECRUITING

    United States, South Carolina

    Medical University of South Carolina (MUSC) - Hollings CC

    Charleston, South Carolina, United States, 29425

    RECRUITING

    United States, Tennessee

    Sarah Cannon Research Institue Oncology

    Nashville, Tennessee, United States, 37203

    RECRUITING

    United States, Texas

    START - South Texas Accelerated Research Therapeutics

    San Antonio, Texas, United States, 78229

    RECRUITING

    United States, Utah

    START Mountain Region

    West Valley City, Utah, United States, 84119

    RECRUITING

    Australia, New South Wales

    Scientia Clinical Research Ltd

    Randwick, New South Wales, Australia, 2031

    NOT YET RECRUITING

    Australia, Queensland

    Mother Cance Care Center, Mother of Mercy Limited

    South Brisbane, Queensland, Australia, 4101

    RECRUITING

    Australia, Queensland

    Gold Coast Private Hospital

    Southport, Queensland, Australia, 4125

    RECRUITING

    Australia, Queensland

    Macquarie University

    Sydney, Queensland, Australia, 2109

    RECRUITING

    Australia, Queensland

    Princess Alexandra Hospital

    Woolloongabba, Queensland, Australia, 4102

    RECRUITING

    Australia, Victoria

    Peninsula and south eastern haematology and oncology group

    Frankston, Victoria, Australia, 3199

    RECRUITING

    China,

    Chongqing University Cancer Hospital

    Chongqing, China, 400044

    RECRUITING

    China,

    Zhejiang Cancer Hospital

    Hangzhou, China, 310022

    RECRUITING

    China,

    Fudan University Shanghai Cancer Center

    Shanghai, China, 200120

    RECRUITING

    Korea, Republic of, Gone

    CHA Bundang Medical Center, CHA University

    Seongnam-shi, Gyeongggi-do, Korea, Republic of, 13496

    RECRUITING

    Korea, Republic of, Nam move-so

    Gachon University - Gil Medical Center

    Incheon, Nam move-so, Korea, Republic of, 21565

    RECRUITING

    Korea, Republic of,

    Severance Hospital, Yonsei University Health System

    Seoul, Korea, Republic of, 03722