A Study of PARP1 Selective Inhibitor, EIK1004 (IMP1707) in Participants With Advanced Solid Tumors.

Sponsor: Eikon Therapeutics

Sponsor score: 0

ClinicalTrials ID:NCT06907043

This Phase 1/2 study assesses the safety, tolerability, and preliminary efficacy of EIK1004 (IMP1707) in patients with advanced solid tumors, including breast, ovarian, prostate, and pancreatic cancers with HRR gene mutations. It involves dose escalation to determine MTD/MAD and dose optimization for safety and efficacy. Eligible participants include those with untreated or treated CNS metastases.

Patient Parameters

Program Overview

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

Description

This study will evaluate the safety, tolerability and preliminary efficacy of EIK1004 (IMP1707) as monotherapy in patients with recurrent, advanced/metastatic solid tumors. The study consists of 2 parts: Dose escalation and dose optimization.

In dose escalation (Part1), the study will identify the maximum tolerated dose (MTD) or maximum achievable dose (MAD) in solid tumor.

In dose optimization (Part 2), the study will further evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of select doses of EIK1004 (IMP1707)

Eligibility Criteria

Inclusion Criteria

  • 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.

Locations

FACILITYZIPCITYSTATE
MD Anderson77030HoustonTexas

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