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

Last updated: November 24, 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

    Site Not Available

  • Scientia Clinical Research Ltd

    Randwick 2208285, New South Wales 2155400 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

    Site Not Available

  • Princess Alexandra Hospital

    Woolloongabba, Queensland 4102
    Australia

    Site Not Available

  • Mater Cancer Care Centre, Mater Misericordiae Limited

    South Brisbane 2207259, Queensland 2152274 4101
    Australia

    Active - Recruiting

  • Gold Coast Private Hospital

    Southport 2148928, Queensland 2152274 4125
    Australia

    Active - Recruiting

  • Macquarie University

    Sydney, Queensland 2152274 2109
    Australia

    Active - Recruiting

  • Princess Alexandra Hospital

    Woolloongabba 6943568, Queensland 2152274 4102
    Australia

    Active - Recruiting

  • Peninsula and south eastern haematology and oncology group

    Frankston, Victoria 3199
    Australia

    Site Not Available

  • Peninsula and south eastern haematology and oncology group

    Frankston 2166144, Victoria 2145234 3199
    Australia

    Active - Recruiting

  • Cross Cancer Institute

    Edmonton 5946768, Alberta 5883102 T6G 1Z2
    Canada

    Active - Recruiting

  • BC Cancer Vancouver

    Vancouver 6173331, British Columbia 5909050 V5Z 4E6
    Canada

    Site Not Available

  • Princess Margaret Cancer Centre-University Health Network

    Toronto 6167865, Ontario 6093943 M5G 2M9
    Canada

    Active - Recruiting

  • Sunnybrook Research Institute

    Toronto 6167865, Ontario 6093943 M4N 3M5
    Canada

    Active - Recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou 1809858, Guangdong 1809935 510060
    China

    Active - Recruiting

  • Chongqing University Cancer Hospital

    Chongqing, 400044
    China

    Site Not Available

  • Chongqing University Cancer Hospital

    Chongqing 1814906, 400044
    China

    Active - Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, 310022
    China

    Site Not Available

  • Zhejiang Cancer Hospital

    Hangzhou 1808926, 310022
    China

    Active - Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, 200120
    China

    Site Not Available

  • Fudan University Shanghai Cancer Center

    Shanghai 1796236, 200120
    China

    Active - Recruiting

  • Righospitalet

    Copenhagen 2618425, 2100
    Denmark

    Active - Recruiting

  • Hospices Civils de Lyon - CHU Lyon Sud

    Pierre-Bénite 2987314, Rhone 69310
    France

    Active - Recruiting

  • CLCC François Baclesse

    Caen 3029241, 14075
    France

    Active - Recruiting

  • Institut Gustave Roussy

    Villejuif 2968705, 94805
    France

    Active - Recruiting

  • CHA Bundang Medical Center, CHA University

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

    Site Not Available

  • Gachon University - Gil Medical Center

    Incheon, Namdong-gu 21565
    Korea, Republic of

    Site Not Available

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722
    Korea, Republic of

    Site Not Available

  • CHA Bundang Medical Center, CHA University

    Seongnam-si 1897000, Gyeonggi-do 1841610 13496
    South Korea

    Active - Recruiting

  • Gachon University - Gil Medical Center

    Incheon 1843564, Namdong-gu 21565
    South Korea

    Active - Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul 1835848, 03722
    South Korea

    Active - Recruiting

  • Hospital Universitari Parc Taulí

    Sabadell 3111199, Barcelona 08208
    Spain

    Active - Recruiting

  • Hospital Clinico San Carlos

    Madrid 3117735, Madrid 3117732 28040
    Spain

    Active - Recruiting

  • Clínica Universidad de Navarra - Hospital

    Pamplona 3114472, Navarre 3115609 31008
    Spain

    Active - Recruiting

  • Hospital del Mar

    Barcelona 3128760, 08003
    Spain

    Active - Recruiting

  • Vall d'Hebron Institute of Oncology

    Barcelona 3128760, 08035
    Spain

    Active - Recruiting

  • Fundacion MD Anderson Cancer Center

    Madrid 3117735, 28033
    Spain

    Active - Recruiting

  • START Madrid Fundación Jiménez Díaz

    Madrid 3117735, 28040
    Spain

    Active - Recruiting

  • START-CIOCC HM Sanchinarro Hospital

    Madrid 3117735, 28050
    Spain

    Active - Recruiting

  • Universidad De Sevilla - Hospital Universitario Virgen Macarena

    Seville 2510911, 41009
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario de Valencia - INCLIVA

    Valencia 2509954, 46010
    Spain

    Active - Recruiting

  • The University of Arizona Cancer Center

    Tucson 5318313, Arizona 5551752 85719
    United States

    Active - Recruiting

  • University of Arkansas Winthrop P. Rockefeller Cancer Institute

    Little Rock 4119403, Arkansas 4099753 72205
    United States

    Site Not Available

  • University California Irvine

    Irvine, California 92868
    United States

    Site Not Available

  • University of California San Francisco (UCSF)

    San Francisco, California 94158
    United States

    Site Not Available

  • Hoag Health Center Irvine

    Irvine 5359777, California 5332921 92618
    United States

    Active - Recruiting

  • University California Irvine

    Irvine 5359777, California 5332921 92868
    United States

    Active - Recruiting

  • Sharp Memorial Hospital

    San Diego 5391811, California 5332921 92123
    United States

    Site Not Available

  • University of California San Francisco (UCSF)

    San Francisco 5391959, California 5332921 94158
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute Health One

    Denver, Colorado 80218
    United States

    Site Not Available

  • Sarah Cannon Research Institute Health One

    Denver 5419384, Colorado 5417618 80218
    United States

    Active - Recruiting

  • Smilow Cancer Hospital at Yale New Haven

    New Haven, Connecticut 06511
    United States

    Site Not Available

  • Smilow Cancer Hospital at Yale New Haven

    New Haven 4839366, Connecticut 4831725 06511
    United States

    Active - Recruiting

  • Advent Health Research Institute

    Celebration, Florida 34747
    United States

    Site Not Available

  • Advent Health Research Institute

    Celebration 4150394, Florida 4155751 34747
    United States

    Active - Recruiting

  • Sylvester Comprehensive Cancer Center

    Miami 4164138, Florida 4155751 33136
    United States

    Site Not Available

  • Karmanos Cancer Institute

    Detroit, Michigan 48201
    United States

    Site Not Available

  • University of Michigan Rogel Cancer Center

    Ann Arbor 4984247, Michigan 5001836 48109
    United States

    Site Not Available

  • Henry Ford Health

    Detroit 4990729, Michigan 5001836 48202
    United States

    Site Not Available

  • Karmanos Cancer Institute

    Detroit 4990729, Michigan 5001836 48201
    United States

    Active - Recruiting

  • University of Minnesota-Clinical Research Unit

    Minneapolis 5037649, Minnesota 5037779 55455
    United States

    Site Not Available

  • Washington University - Siteman Cancer Center

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University - Siteman Cancer Center

    St Louis 4407066, Missouri 4398678 63110
    United States

    Active - Recruiting

  • John Theurer Cancer Center

    Hackensack 5098706, New Jersey 5101760 07601
    United States

    Site Not Available

  • Cayuga Medical Center

    Ithaca, New York 14850
    United States

    Site Not Available

  • Cayuga Medical Center

    Ithaca 5122432, New York 5128638 14850
    United States

    Active - Recruiting

  • Lifespan Cancer Institute

    Providence 5224151, Rhode Island 5224323 02903
    United States

    Active - Recruiting

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

    Charleston, South Carolina 29425
    United States

    Site Not Available

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

    Charleston 4574324, South Carolina 4597040 29425
    United States

    Active - Recruiting

  • Sarah Cannon Research Institue Oncology

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • West Cancer Center & Research Institute

    Germantown 4624601, Tennessee 4662168 38138
    United States

    Active - Recruiting

  • Sarah Cannon Research Institue Oncology

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Active - Recruiting

  • START - South Texas Accelerated Research Therapeutics

    San Antonio, Texas 78229
    United States

    Site Not Available

  • START - South Texas Accelerated Research Therapeutics

    San Antonio 4726206, Texas 4736286 78229
    United States

    Active - Recruiting

  • START Mountain Region

    West Valley City, Utah 84119
    United States

    Site Not Available

  • START Mountain Region

    West Valley City 5784607, Utah 5549030 84119
    United States

    Active - Recruiting

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