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RecruitingLast updated: 18 December 2025

EIK1003-001: The safety and effectiveness of a targeted drug (called IMP1734) in people with recurrent advanced, metastatic breast cancer, ovarian cancer or castrate resistant prostate cancerA First-in-human, Phase 1/2, 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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Multi-Cancer Multi-Cancer

Age

People18 - 89

Trial acronym

EIK1003-001

Clinical summary

Summary

This study will evalaute how safe, tolerable and effective a targeted drug called IMP1734 is when given by itself in people with recurrent, advanced or metastatic solid cancers. The study consists of 3 parts: dose escalation, dose optimsiation and dose expansion.

In dose escalation (part 1), researchers will evaluate different dose levels of IMP1734 to determine the maximum tolerated dose (MTD) or maximum achieveable dose (MAD) in people with solid cancers.

In dose optimisation (part 2), researchers will further evaluate how safe, tolerable and effective certain doses of IMP1734 are, as well as how they interact in the body.

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

 

Conditions

This trial is treating people with breast cancer, high grade endometrioid epithelial ovarian cancer, high grade serous ovarian cancer, fallopian tube cancer, primary peritoneal cancer, or metastatic castration resistant prostate cancer

Eligibility

Inclusion

  • 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

  • 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

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You are able to swallow medication by mouth.

Exclusion

  • You are currently being treated on a clinical trial.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:

Trial sponsor

Eikon Therapeutics

Scientific Title

A First-in-human, Phase 1/2, 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

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