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Recruiting Phase 1/2

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

NCT06253130 · tracked via the Priya Life Science France tracker
Phase
Phase 1/2
Started
2023-12-11
Last updated
2026-06-15

Condition(s) studied

Advanced Solid Tumor

Investigational drug(s) / intervention(s)

IMP1734

IMP1734: PARP1 selective inhibitor

Study summary

This study investigates the safety and tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of EIK1003 in participants with advanced solid tumors.

Eligibility

Sex
ALL
Min age
18 Years
Max age
89 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Number of subjects with adverse events, treatment emergent adverse events or serious adverse events — Consent to 30 + 7 days post last dose of IMP1734
    Number of subjects reporting adverse events or serious adverse events which include any abnormal clinical events, laboratory assessments outside of normal clinical range, abnormal vital signs observed, and any abnormal ECG parameters
  • Maxim Tolerated Dose or Recommended Dose for Expansion — DLT period is from the first dose of the study drug until the last day of the first cycle
    Number of patients that experience a DLT or any toxicity which occurs from the time of the first dose of study drug until the end of cycle 1, which is deemed unrelated to the disease.

Trial sites (57)

FacilityCityRegionStatus
The University of Arizona Cancer Center Tucson Arizona Recruiting
University of Arkansas Winthrop P. Rockefeller Cancer Institute Little Rock Arkansas Recruiting
Hoag Health Center Irvine Irvine California Withdrawn
University California Irvine Irvine California Withdrawn
Sharp Memorial Hospital San Diego California Withdrawn
University of California San Francisco (UCSF) San Francisco California Withdrawn
Sarah Cannon Research Institute Health One Denver Colorado Recruiting
Smilow Cancer Hospital at Yale New Haven New Haven Connecticut Recruiting
Advent Health Research Institute Celebration Florida Recruiting
Sylvester Comprehensive Cancer Center Miami Florida Recruiting
University of Michigan Rogel Cancer Center Ann Arbor Michigan Recruiting
Karmanos Cancer Institute Detroit Michigan Recruiting
Henry Ford Health Detroit Michigan Recruiting
University of Minnesota-Clinical Research Unit Minneapolis Minnesota Recruiting
Washington University - Siteman Cancer Center St Louis Missouri Withdrawn
John Theurer Cancer Center Hackensack New Jersey Withdrawn
Cayuga Medical Center Ithaca New York Withdrawn
Lifespan Cancer Institute Providence Rhode Island Recruiting
Medical University of South Carolina (MUSC) - Hollings CC Charleston South Carolina Recruiting
West Cancer Center & Research Institute Germantown Tennessee Recruiting
Sarah Cannon Research Institue Oncology Nashville Tennessee Recruiting
START - South Texas Accelerated Research Therapeutics San Antonio Texas Withdrawn
START Mountain Region West Valley City Utah Withdrawn
Scientia Clinical Research Ltd Randwick New South Wales Active Not Recruiting
Mater Cancer Care Centre, Mater Misericordiae Limited South Brisbane Queensland Recruiting
Gold Coast Private Hospital Southport Queensland Not Yet Recruiting
Macquarie University Sydney Queensland Recruiting
Princess Alexandra Hospital Woolloongabba Queensland Recruiting
Peninsula and south eastern haematology and oncology group Frankston Victoria Recruiting
Cross Cancer Institute Edmonton Alberta Recruiting
Sunnybrook Research Institute Toronto Ontario Recruiting
Princess Margaret Cancer Centre-University Health Network Toronto Ontario Recruiting
Sun Yat-sen University Cancer Center Guangzhou Guangdong Recruiting
The Fourth Hospital of Hebei Medical University Shijiazhuang Hebei Recruiting
Shandong Cancer Hospital Jinan Shandong Recruiting
Sir Run Run Shaw Hospital Zhejiang University School of Medicine Hangzhou Zhejiang Recruiting
Chongqing University Cancer Hospital Chongqing China Recruiting
Fujian Cancer Hospital Fuzhou China Recruiting
Zhejiang Cancer Hospital Hangzhou China Recruiting
Fudan University Shanghai Cancer Center Shanghai China Recruiting

+ 17 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06253130 on ClinicalTrials.gov ↗ ← All trials in France