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Not yet recruitingLast updated: 16 April 2024

EIK1003-001: This study is recruiting people with recurrent, advanced or metastatic breast cancer, ovarian cancer or metastatic castration resistant prostate cancer, and aims to determine the safety, efficacy and recommended dose level of a new targeted therapy drug (called IMP1734)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

Clinical summary

Summary

This study consists of three parts: Dose Escalation, Dose Optimisation and Dose Expansion. 

In Dose Escalation (Part 1), the study will identify the maximum tolerated dose (MTD) or maximum achievable dose (MAD). 

In Dose Optimisation (Part 2), the study will further evaluate how safe, tolerable and effective select doses of IMP1734 are.

In Dose Expansion (Part 3), the recommended dose escalation (RDE) of IMP1734 monotherapy will be evaluated.

IMP1734, which is a PARP1 selective inhibitor, will be administered as oral daily tablets. The maximum trial duration is three years after the last participant's first treatment in the trial. 

Conditions

This trial is treating patients with breast cancer, ovarian cancer or metastatic castration resistant prostate cancer (mCRPC) with deleterious/suspected deleterious mutations of select homologous recombination repair (HRR) gene mutations

Cancer

Multi-Cancer Multi-Cancer

Age

People18 - 89

Phase

I/II

Trial Acronym

EIK1003-001

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

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

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 HHR 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 are able to swallow medication by mouth.
  • You have had treatment, but your cancer has come back.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
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Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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