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A Study of PARP1 Selective Inhibitor, EIK1004 (IMP1707) in Participants With Advanced Solid Tumors.
Trial Status: active
This study will evaluate the safety, tolerability, and preliminary efficacy of EIK1004
(IMP1707) in participants with recurrent advanced/metastatic breast cancer, ovarian
cancer, metastatic castrate resistant prostate cancer (mCRPC) and pancreatic cancer with
deleterious/suspected deleterious mutations of select homologous recombination repair
(HRR) genes.
Condition or disease Intervention/treatment Phase Advanced Solid Tumors Drug: EIK1004
(IMP1707) Phase 1/Phase 2
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.
Additional locations may be listed on ClinicalTrials.gov for NCT06907043.
Locations matching your search criteria
United States
Connecticut
New Haven
Yale University
Status: Active
Name Not Available
Trumbull
Smilow Cancer Hospital Care Center-Trumbull
Status: Active
Name Not Available
Massachusetts
Boston
Beth Israel Deaconess Medical Center
Status: Active
Name Not Available
Michigan
Detroit
Wayne State University/Karmanos Cancer Institute
Status: Approved
Name Not Available
Texas
Houston
M D Anderson Cancer Center
Status: Active
Name Not Available
This study will evaluate the safety, tolerability and preliminary efficacy of EIK1004
(IMP1707) as monotherapy in patients with recurrent, advanced/metastatic solid tumors.
The study consists of 2 parts: Dose escalation and dose optimization.
In dose escalation (Part1), the study will identify the maximum tolerated dose (MTD) or
maximum achievable dose (MAD) in solid tumor.
In dose optimization (Part 2), the study will further evaluate the safety, tolerability,
pharmacokinetics, pharmacodynamics, and anti-tumor activity of select doses of EIK1004
