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RecruitingInterventionalPhase 1/Phase 2

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

NCT ID: NCT06253130Sponsor: Eikon TherapeuticsLast updated: 2026-06-15

Summary

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

Detailed description

This study will evaluate the safety, tolerability and preliminary efficacy of IMP1734 as monotherapy in patients with recurrent, advanced/metastatic solid tumors. This study includes 2 parts: Part 1 and Part 2. Part 1 includes a monotherapy dose escalation of EIK1003 followed by combination dose escalations in metastatic prostate cancer (mPC), ovarian and breast cancer. Part 1, dose escalation, the study will identify the maximum tolerated dose (MTD) or maximum achievable dose (MAD) in solid tumor. Part 2 will explore dose optimization with selection of an optimal dose for future clinical development of EIK1003.

Arms & interventions

  • DrugIMP1734

    PARP1 selective inhibitor

Outcome measures

Primary

  • Number of subjects with adverse events, treatment emergent adverse events or serious adverse events

    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

    Time frame: Consent to 30 + 7 days post last dose of IMP1734

  • Maxim Tolerated Dose or Recommended Dose for Expansion

    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.

    Time frame: DLT period is from the first dose of the study drug until the last day of the first cycle

Secondary

  • Pharmacokinetic parameters of IMP1734

    Time frame: Through study completion, up to 3 years

  • Pharmacokinetic parameters of IMP1734

    Time frame: Through study completion, up to 3 years

  • Pharmacokinetic parameters of IMP1734

    Time frame: Through study completion, up to 3 years

  • Overall Response Rate

    Time frame: Through study completion, up to 3 years

Eligibility criteria

Sex: AllAge: 18 Years to 89 YearsHealthy 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

Study locations (23)

The University of Arizona Cancer Center

Tucson, Arizona, 85719

Recruiting
Spencer Study Coordinator · Contact
Alejandro Recio-Boiles, MD · Principal Investigator

University of Arkansas Winthrop P. Rockefeller Cancer Institute

Little Rock, Arkansas, 72205

Recruiting
Maroof Study Coordinator · Contact
Michael Birrer, MD · Principal Investigator

Hoag Health Center Irvine

Irvine, California, 92618

Withdrawn

University California Irvine

Irvine, California, 92868

Withdrawn

Sharp Memorial Hospital

San Diego, California, 92123

Withdrawn

University of California San Francisco (UCSF)

San Francisco, California, 94158

Withdrawn

Sarah Cannon Research Institute Health One

Denver, Colorado, 80218

Recruiting
Hannah Study Nurse · Contact
Gerald Falchook, MD · Principal Investigator

Smilow Cancer Hospital at Yale New Haven

New Haven, Connecticut, 06511

Recruiting
Sarah Reinwald · Contact
Patricia LoRusso, MD · Principal Investigator

Advent Health Research Institute

Celebration, Florida, 34747

Recruiting
Jamayra Study Coordinator · Contact
Guru Sonpavde, MD · Principal Investigator

Sylvester Comprehensive Cancer Center

Miami, Florida, 33136

Recruiting
Lauren Study Coordinator · Contact
Frances Valdes-Albini, MD · Principal Investigator

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109

Recruiting
Myron Study Coordinator · Contact
Aki Morikawa, MD · Principal Investigator

Karmanos Cancer Institute

Detroit, Michigan, 48201

Recruiting
Brenda Research Nurse · Contact
Yusra Shao, MD · Principal Investigator

Henry Ford Health

Detroit, Michigan, 48202

Recruiting
Andrew Study Coordinator · Contact
Amy Weise, MD · Principal Investigator

University of Minnesota-Clinical Research Unit

Minneapolis, Minnesota, 55455

Recruiting
Elizabeth Study Coordinator · Contact
Heather Beckwith, MD · Principal Investigator

Washington University - Siteman Cancer Center

St Louis, Missouri, 63110

Withdrawn

John Theurer Cancer Center

Hackensack, New Jersey, 07601

Withdrawn

Cayuga Medical Center

Ithaca, New York, 14850

Withdrawn

Lifespan Cancer Institute

Providence, Rhode Island, 02903

Recruiting
Sopha Research Nurse · Contact
Benedito Carneiro, MD · Principal Investigator

Medical University of South Carolina (MUSC) - Hollings CC

Charleston, South Carolina, 29425

Recruiting
Abigail Study Coordinator · Contact
Brian Orr, MD · Principal Investigator

West Cancer Center & Research Institute

Germantown, Tennessee, 38138

Recruiting
Rebecca Study Coordinator · Contact
Daniel Vaena, MD · Principal Investigator

Sarah Cannon Research Institue Oncology

Nashville, Tennessee, 37203

Recruiting
Emma Study Coordinator · Contact
Benjamin Garmezy, MD · Principal Investigator

START - South Texas Accelerated Research Therapeutics

San Antonio, Texas, 78229

Withdrawn

START Mountain Region

West Valley City, Utah, 84119

Withdrawn