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Testing a new drug, IMP1734, for advanced solid tumors

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

PHASE1; PHASE2 · Eikon Therapeutics · NCT06253130

This study is testing a new drug called IMP1734 to see if it can safely help people with advanced solid tumors like breast, ovarian, and prostate cancer.

Quick facts

PhasePHASE1; PHASE2
Study typeInterventional
Enrollment156 (estimated)
Ages18 Years to 89 Years
SexAll
SponsorEikon Therapeutics (industry)
Drugs / interventionschemotherapy
Locations53 sites (Tucson, Arizona and 52 other locations)
Trial IDNCT06253130 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, tolerability, and preliminary efficacy of IMP1734, a PARP1 selective inhibitor, in patients with recurrent advanced solid tumors, including breast cancer, ovarian cancer, and metastatic castrate-resistant prostate cancer (mCRPC). The study is divided into three parts: dose escalation to determine the maximum tolerated dose, dose optimization to assess pharmacokinetics and anti-tumor activity, and dose expansion to evaluate the recommended dose in specific patient populations with deleterious mutations in homologous recombination repair genes. Participants will receive IMP1734 as a monotherapy.

Who should consider this trial

Good fit: Ideal candidates include adults with recurrent advanced solid tumors who have specific genetic mutations and have previously undergone certain lines of chemotherapy.

Not a fit: Patients without deleterious mutations in homologous recombination repair genes or those who have not met the prior treatment criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors harboring specific genetic mutations.

How similar studies have performed: Other studies involving PARP inhibitors have shown promising results, indicating potential success for this novel approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria

* 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

Key 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

Where this trial is running

Tucson, Arizona and 52 other locations

+3 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Advanced Solid Tumor, EIK1003, EIK1003-001, IMP1734

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.