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

Last updated: April 14, 2025
Sponsor: Eikon Therapeutics
Overall Status: Active - Recruiting

Phase

1/2

Condition

Neoplasms

Treatment

IMP1734

Clinical Study ID

NCT06253130
EIK1003-001 (IMP1734-101)
2023-509230-19
  • Ages 18-89
  • All Genders

Study 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 Criteria

Inclusion

Key Inclusion Criteria

  • Breast cancer; must have received at least one prior chemotherapy inneoadjuvant/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 advanceddisease

  • mCRPC with ongoing ADT, must have received NHA and up to 1 prior line of taxanechemotherapy

  • 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 aneffective method of contraception from study entry up to 6 months after the lastdose of IMP1734

  • deleterious or suspected deleterious germline or somatic mutations of select HRRgenes

  • up to 1 prior line of PARP inhibitor containing treatment

Exclusion

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 carcinomatousmeningitis.

  • Infections

  • An active hepatitis B/C infection

  • Any known predisposition to bleeding

  • Unable to swallow oral medications OR have malabsorption syndrome or any otheruncontrolled gastrointestinal condition that might impair the bioavailability

Study Design

Total Participants: 70
Treatment Group(s): 1
Primary Treatment: IMP1734
Phase: 1/2
Study Start date:
December 11, 2023
Estimated Completion Date:
December 01, 2026

Study 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.

Connect with a study center

  • Scientia Clinical Research Ltd

    Randwick, New South Wales 2031
    Australia

    Active - Recruiting

  • Mater Cancer Care Centre, Mater Misericordiae Limited

    South Brisbane, Queensland 4101
    Australia

    Site Not Available

  • Gold Coast Private Hospital

    Southport, Queensland 4125
    Australia

    Active - Recruiting

  • Macquarie University

    Sydney, Queensland 2109
    Australia

    Active - Recruiting

  • Princess Alexandra Hospital

    Woolloongabba, Queensland 4102
    Australia

    Active - Recruiting

  • Peninsula and south eastern haematology and oncology group

    Frankston, Victoria 3199
    Australia

    Active - Recruiting

  • Chongqing University Cancer Hospital

    Chongqing, 400044
    China

    Active - Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, 310022
    China

    Active - Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, 200120
    China

    Active - Recruiting

  • CHA Bundang Medical Center, CHA University

    Seongnam-si, Gyeonggi-Do 13496
    Korea, Republic of

    Active - Recruiting

  • Gachon University - Gil Medical Center

    Incheon, Namdong-gu 21565
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722
    Korea, Republic of

    Active - Recruiting

  • University California Irvine

    Irvine, California 92868
    United States

    Active - Recruiting

  • University of California San Francisco (UCSF)

    San Francisco, California 94158
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute Health One

    Denver, Colorado 80218
    United States

    Active - Recruiting

  • Smilow Cancer Hospital at Yale New Haven

    New Haven, Connecticut 06511
    United States

    Active - Recruiting

  • Advent Health Research Institute

    Celebration, Florida 34747
    United States

    Active - Recruiting

  • Karmanos Cancer Institute

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • Washington University - Siteman Cancer Center

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Cayuga Medical Center

    Ithaca, New York 14850
    United States

    Active - Recruiting

  • Medical University of South Carolina (MUSC) - Hollings CC

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • Sarah Cannon Research Institue Oncology

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • START - South Texas Accelerated Research Therapeutics

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • START Mountain Region

    West Valley City, Utah 84119
    United States

    Active - Recruiting

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