A Study of PARP1 Selective Inhibitor, EIK1004 (IMP1707) in Participants With Advanced Solid Tumors.

Launched by EIKON THERAPEUTICS · Mar 31, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new drug called EIK1004 (also known as IMP1707) to see how safe it is and how well it works in treating advanced solid tumors, specifically in patients with recurrent breast cancer, ovarian cancer, metastatic prostate cancer, and pancreatic cancer. The study is focused on patients who have certain genetic mutations that affect how their cancer cells repair damage. The trial is currently not recruiting participants, but when it starts, it will include adults aged 18 and older who meet specific health criteria.

To be eligible for the trial, participants should have already tried other cancer treatments, such as chemotherapy, and should have specific types of cancer that have certain genetic mutations. They will need to agree to use effective birth control during the study. If you join, you can expect regular check-ins with the medical team to monitor your health and how well the drug is working. It’s also important to know that there are specific health conditions that may prevent someone from participating, such as having certain active infections or untreated brain lesions. This trial aims to provide new treatment options for patients with advanced cancers who have limited choices left.

Gender

ALL

Eligibility 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; 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.