Evaluating EIK1004 for Advanced Solid Tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study assesses the safety, tolerability, and preliminary efficacy of EIK1004 (IMP1707) in patients with advanced solid tumors, including breast, ovarian, prostate, and pancreatic cancers. It consists of two parts: a dose escalation phase to determine the maximum tolerated dose and a dose optimization phase to evaluate the drug's pharmacokinetics, pharmacodynamics, and anti-tumor activity. Participants must have specific genetic mutations related to homologous recombination repair to qualify for the study.

Why it matters

Who can join: the full rules

• 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

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.

Where it's running

• Sarah Cannon Research Institute at HealthOne
  Denver, Colorado, United States Recruiting
• Florida Cancer Center
  Lake Mary, Florida, United States Recruiting
• Beth Israel Deaconess Medical Center
  Boston, Massachusetts, United States Recruiting
• MD Anderson
  Houston, Texas, United States Recruiting
• NEXT Oncology
  San Antonio, Texas, United States Recruiting
• NEXT Virginia
  Fairfax, Virginia, United States Recruiting

Study contacts

• Study coordinator: Sunny Chaudry, MS
• Email: chaudrys@eikontx.com
• Phone: 6319026200

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.