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-IMP1734-101
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]
Recruiting

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Study Summary

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

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.

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
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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 Madrid, Spain (CIOCC)
Madrid, Spain, 28050
Investigator
Ramon Yarza
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 San Antonio
San Antonio, TX, United States, 78229
Investigator
Drew Rasco
Status
Recruiting
Condition(s) Treated at Site
Solid Tumor