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.
• 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.
Primary outcome measure(s)
Number of Participants who experience a Dose-Limiting Toxicity (DLT) — (Timeframe: up to 28 days) A DLT is defined as an event with toxicity including the type, severity, time of onset, time of resolution, and the probable association with study treatment that are not due to pre-existing conditions as defined by the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE 5.0). The number of participants who experience a DLT will be reported.
Number of participants with adverse events, treatment emergent adverse events or serious adverse events — (Time Frame: 1 month post last dose of EIK1004 (IMP1707) Number of participants reporting adverse events or serious adverse events which include any abnormal clinical events, laboratory assessments outside of normal clinical range, abnormal vital signs observed, and any abnormal ECG parameters
Trial sites (10)
Facility
City
Region
Status
Sarah Cannon Research Institute at HealthOne
Denver
Colorado
Recruiting
Florida Cancer Center
Lake Mary
Florida
Recruiting
Beth Israel Deaconess Medical Center
Boston
Massachusetts
Recruiting
MD Anderson
Houston
Texas
Recruiting
NEXT Oncology
San Antonio
Texas
Recruiting
NEXT Virginia
Fairfax
Virginia
Recruiting
PASO Medical
Frankston
Victoria
Recruiting
Chongqing University Cancer Hospital
Chongqing
Chongqing Municipality
Recruiting
Cancer Hospital of Shandong First Medical University(Shandong Cancer Institute, Shandong Cancer Hospital)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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