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

RecruitingPhase 1/2

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

Who can join

Ages 18 to 89 · All sexes

Full eligibility criteria
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

About the study

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

What is being tested

Sponsor: Eikon Therapeutics · Participants: 156 · Started: Dec 11, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT06253130

Locations in the U.S.

ArizonaThe University of Arizona Cancer Center, Tucson
ArkansasUniversity of Arkansas Winthrop P. Rockefeller Cancer Institute, Little Rock
ColoradoSarah Cannon Research Institute Health One, Denver
ConnecticutSmilow Cancer Hospital at Yale New Haven, New Haven
FloridaAdvent Health Research Institute, Celebration
Sylvester Comprehensive Cancer Center, Miami
MichiganUniversity of Michigan Rogel Cancer Center, Ann Arbor
Henry Ford Health, Detroit
Karmanos Cancer Institute, Detroit
MinnesotaUniversity of Minnesota-Clinical Research Unit, Minneapolis
Rhode IslandLifespan Cancer Institute, Providence
South CarolinaMedical University of South Carolina (MUSC) - Hollings CC, Charleston
TennesseeWest Cancer Center & Research Institute, Germantown
Sarah Cannon Research Institue Oncology, Nashville

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.