A First-in-human Study of PARP1 Selective Inhibitor, IMP1734, in Participants With Advanced Solid Tumors
NCT ID: NCT06253130
Last Updated: 2025-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
70 participants
INTERVENTIONAL
2023-12-11
2026-12-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Cohort 1
IMP1734 monotherapy; oral tablet(s) daily (except for the single-dose period). The maximum trial duration is 3 years after the last participant's first treatment in the trial.
IMP1734
PARP1 selective inhibitor
Interventions
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IMP1734
PARP1 selective inhibitor
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
89 Years
ALL
No
Sponsors
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Impact Therapeutics, Inc.
INDUSTRY
Eikon Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Viola Chen, MD
Role: STUDY_DIRECTOR
Eikon Therapeutics
Locations
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The University of Arizona Cancer Center
Tucson, Arizona, United States
University of Arkansas Winthrop P. Rockefeller Cancer Institute
Little Rock, Arkansas, United States
Hoag Health Center Irvine
Irvine, California, United States
University California Irvine
Irvine, California, United States
Sharp Memorial Hospital
San Diego, California, United States
University of California San Francisco (UCSF)
San Francisco, California, United States
Sarah Cannon Research Institute Health One
Denver, Colorado, United States
Smilow Cancer Hospital at Yale New Haven
New Haven, Connecticut, United States
Advent Health Research Institute
Celebration, Florida, United States
Sylvester Comprehensive Cancer Center
Miami, Florida, United States
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Henry Ford Health
Detroit, Michigan, United States
University of Minnesota-Clinical Research Unit
Minneapolis, Minnesota, United States
Washington University - Siteman Cancer Center
St Louis, Missouri, United States
John Theurer Cancer Center
Hackensack, New Jersey, United States
Cayuga Medical Center
Ithaca, New York, United States
Lifespan Cancer Institute
Providence, Rhode Island, United States
Medical University of South Carolina (MUSC) - Hollings CC
Charleston, South Carolina, United States
West Cancer Center & Research Institute
Germantown, Tennessee, United States
Sarah Cannon Research Institue Oncology
Nashville, Tennessee, United States
START - South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States
START Mountain Region
West Valley City, Utah, United States
Scientia Clinical Research Ltd
Randwick, New South Wales, Australia
Mater Cancer Care Centre, Mater Misericordiae Limited
South Brisbane, Queensland, Australia
Gold Coast Private Hospital
Southport, Queensland, Australia
Macquarie University
Sydney, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Peninsula and south eastern haematology and oncology group
Frankston, Victoria, Australia
Cross Cancer Institute
Edmonton, Alberta, Canada
BC Cancer Vancouver
Vancouver, British Columbia, Canada
Sunnybrook Research Institute
Toronto, Ontario, Canada
Princess Margaret Cancer Centre-University Health Network
Toronto, Ontario, Canada
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Chongqing University Cancer Hospital
Chongqing, , China
Zhejiang Cancer Hospital
Hangzhou, , China
Fudan University Shanghai Cancer Center
Shanghai, , China
Righospitalet
Copenhagen, , Denmark
Hospices Civils de Lyon - CHU Lyon Sud
Pierre-Bénite, Rhone, France
CLCC François Baclesse
Caen, , France
Institut Gustave Roussy
Villejuif, , France
CHA Bundang Medical Center, CHA University
Seongnam-si, Gyeonggi-do, South Korea
Gachon University - Gil Medical Center
Incheon, Namdong-gu, South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Hospital Universitari Parc Taulí
Sabadell, Barcelona, Spain
Hospital Clinico San Carlos
Madrid, Madrid, Spain
Clínica Universidad de Navarra - Hospital
Pamplona, Navarre, Spain
Hospital del Mar
Barcelona, , Spain
Vall d'Hebron Institute of Oncology
Barcelona, , Spain
Fundacion MD Anderson Cancer Center
Madrid, , Spain
START Madrid Fundación Jiménez Díaz
Madrid, , Spain
START-CIOCC HM Sanchinarro Hospital
Madrid, , Spain
Universidad De Sevilla - Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Clinico Universitario de Valencia - INCLIVA
Valencia, , Spain
Countries
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Central Contacts
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Other Identifiers
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2023-509230-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EIK1003-001 (IMP1734-101)
Identifier Type: -
Identifier Source: org_study_id
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