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

Sponsor: Eikon Therapeutics

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06253130

Provider View

This study assesses the safety, tolerability, and efficacy of IMP1734 in advanced solid tumors through dose escalation, optimization, and expansion phases. Participants must not have recent anti-cancer therapy, prior PARP1 inhibitor use, or certain health conditions. IMP1734 is a PARP1 selective inhibitor administered orally.

Patient Parameters

Program Overview

This study will evaluate the 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.

Description

This study will evaluate the safety, tolerability and preliminary efficacy of IMP1734 as monotherapy in patients with recurrent, advanced/metastatic solid tumors. The study consists of 3 parts: Dose escalation, Dose Optimization and Dose expansion.

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 IMP1734.

In dose expansion (Part 3) the recommended dose escalation (RDE) of IMP1734 monotherapy will be evaluated in patients with recurrent, advanced/metastatic breast cancer, ovarian cancer and mCRPC with deleterious/suspected deleterious mutations of select homologous recombination repair (HRR) gene mutations.

Eligibility Criteria

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

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