A Phase I/II, Open-label, Multicenter, Dose-escalation, and Dose-Optimization Study to Evaluate the Safety, Tolerability, and Activity of EIK1004 (IMP1707) as Monotherapy in Participants With Advanced Solid Tumors

Study Identifier:
EIK1004-001
CT.gov Identifier:
NCT06907043
EudraCT Identifier:
202452000000
EU Trial (CTIS) Number:
2024-520395-99-00
Study Contact Information:
(210) 593-5651 or [email protected]
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Study Summary

This study will evaluate the safety, tolerability, and preliminary efficacy of EIK1004 (IMP1707) in participants with recurrent advanced/metastatic breast cancer, ovarian cancer, metastatic castrate resistant prostate cancer (mCRPC) and pancreatic cancer with deleterious/suspected deleterious mutations of select homologous recombination repair (HRR) genes.

Condition or disease Intervention/treatment Phase Advanced Solid Tumors Drug: EIK1004 (IMP1707) Phase 1/Phase 2

To evaluate the safety and tolerability of EIK1004 monotherapy

To characterize the pharmacokinetic characteristics of EIK1004 in plasma after single and multiple doses

To assess the preliminary anti-tumor activity of EIK1004 monotherapy;

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+ years
    Study Drug
  • Drug: Experimental: Part 1
    • Read More
  • Drug: Intervention/Treatment
  • Drug: Chinese common name: IMP1707
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    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; Pancreatic cancer, must have prior 1L therapy
    • * 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 EIK1004 (IMP1707)
    • * Deleterious or suspected deleterious germline or somatic mutations of select HRR genes
    • * Up to 1 prior line of PARP inhibitor containing treatment
    • CNS
    • * Untreated CNS metastases (measurable and/or non-measurable) not needing immediate local therapy.
    • * Previously treated CNS metastases
    • Key
    Exclusion criteria
    • * Any investigational or approved anti-cancer therapies administered within 28 days/ before the first dose of EIK1004 (IMP1707)
    • * Have received prior PARP1 selective inhibitors
    • * Mean resting QTcF > 470 ms or QTcF < 340 ms
    • * 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
    • CNS Exclusion Criteria
    • * Any untreated brain lesions > 2.0 cm in size.
    • * Ongoing use of systemic corticosteroids for control of symptoms of CNS metastases < 7 days prior to the first dose of study treatment or requirement for > 10 mg prednisone/day.
    • * Any brain lesion requiring immediate local therapy, including (but not limited to) a lesion in an anatomic site where an increase in size or possible treatment-related edema may pose risk to the participant (eg, brain stem lesions).
    • * Known, symptomatic leptomeningeal disease.
    • * Have poorly controlled seizures.

    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 Madrid, Spain (CIOCC)
    Madrid, Spain, 28050
    Investigator
    Ramon Yarza
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor