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RecruitingLast updated: 14 October 2025

EIK1004-001: A study evaluating a new targeted therapy drug called EIK1004 (IMP1707) in people with advanced solid cancersA Phase 1/2, Open-label, Multicenter, Dose-escalation, and Dose-Optimization Study to Evaluate the Safety, Tolerability, and Activity of EIK1004 (IMP1707) as Monotherapy in Participants With Advanced Solid Tumors

Trial purpose

Medical clipboardCancer treatment

Tumor type

Multi-Cancer Multi-Cancer

Age

People18 - 89

Trial acronym

EIK1004-001

Clinical summary

Summary

This study is testing the safety, tolerability, and efficacy of EIK1004 (IMP1707) in participants with recurrent, locally advanced or metastatic solid cancers

The study has 2 parts: dose escalation and dose optimisation.

In Part 1 (Dose Escalation), researchers aim to identify the maximum tolerated dose or maximum achievable dose of EIK1004 in people with solid tumours. In this part, different dose levels of EIK1004 will be evaluated and will be given as a daily oral tablet.

In Part 2 (Dose Optimisation), researchers will further evaluate how safe, tolerable and effective certain doses identified in Part 1 are in people with select solid tumours, including breast, ovarian, prostate and pancreatic cancer.

Conditions

This trial is treating people with advanced solid cancers

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; Pancreatic cancer, must have prior 1L therapy

  • 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 EIK1004 (IMP1707)
  • Deleterious or suspected deleterious germline or somatic mutations of select HRR genes
  • Up to 1 prior line of PARP inhibitor containing treatment

CNS Inclusion Criteria:

  • Untreated CNS metastases (measurable and/or non-measurable) not needing immediate local therapy.
  • Previously treated CNS metastases

Exclusion

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.

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).
  • Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).
  • You are able to swallow medication by mouth.

Exclusion

  • 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 *. View further details about this trial on the registry via the links below:

Trial sponsor

Eikon Therapeutics

Scientific Title

A Phase 1/2, Open-label, Multicenter, Dose-escalation, and Dose-Optimization Study to Evaluate the Safety, Tolerability, and Activity of EIK1004 (IMP1707) as Monotherapy in Participants With Advanced Solid Tumors

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