A First-in-human, Phase I/II, 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

Study Identifier:
EIK1003-001
CT.gov Identifier:
NCT06253130
EudraCT Identifier:
2023-509230-19
EU Trial (CTIS) Number:
2023-509230-19-00
Study Contact Information:
(210) 593-5651 or [email protected]
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Study Summary

To evaluate the safety and 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.

To evaluate the safety and potential antitumor activity of EIK1003 as monotherapy and in combination with abiraterone or paclitaxel in patients with advanced solid tumors.

The study comprises 3 parts: Part 1 (FIH; Dose Escalation), Part 2 (Dose Optimization), and Part 3 (Dose Expansion at the recommended dose for expansion [RDE]).

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Solid Tumor
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I/II
    Sex
    Female & Male
    Age
    18 - 89 Years
    Study Drug
  • Drug: Experimental: Cohort 1
    • Read More
  • Drug: Drug: IMP1734
  • Drug: Experimental drug
  • Drug: ASCO 2024:
  • Drug: Participants were dosed with ElK1003 from 10 mg, 20 mg, 40 mg. 80 mg and 160 mg QD in monotherapy Cohort IA. Dose-escalation cohorts
  • Drug: Cohort 1B: (ElK1003 Combination with Abiraterone 1000 mg QD and rednisone +/- ADT; N 40)
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion 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
    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
    • - pre-specified serum tumor-specific marker

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (FJD)
    Madrid, Spain, 28040
    Investigator
    Bernard Doger de Speville
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor
    Location
    START Mountain Region
    West Valley City, UT, United States, 84119
    Investigator
    Justin Call
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor
    Location
    START Madrid, Spain (CIOCC)
    Madrid, Spain, 28050
    Investigator
    Ramon Yarza
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor
    Location
    START San Antonio
    San Antonio, TX, United States, 78229
    Investigator
    Drew Rasco
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor