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
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 (IMP1707)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
130
PARP1 selective inhibitor
Sarah Cannon Research Institute at HealthOne
Denver, Colorado, United States
RECRUITINGFlorida Cancer Center
Lake Mary, Florida, United States
RECRUITINGNumber of Participants who experience a Dose-Limiting Toxicity (DLT)
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.
Time frame: (Timeframe: up to 28 days)
Number of participants with adverse events, treatment emergent adverse events or serious adverse events
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
Time frame: (Time Frame: 1 month post last dose of EIK1004 (IMP1707)
Pharmacokinetic parameters of EIK1004 (IMP1707)
Peak plasma concentration (Cmax)
Time frame: Through study completion, up to 3 years
Pharmacokinetic parameters of EIK1004 (IMP1707)
Area under the curve (AUC) will be defined
Time frame: Time Frame: Through study completion, up to 3 years
Objective Response (OR)
Defined as participants who have a complete response \[CR\] or Participants who have a partial response \[PR\] by RECIST 1.1 (Solid tumor) and RANO-BM (brain metastasis), or CA-125 response per GCIG criteria (ovarian cancer), or PSA response per PCWG3 criteria.
Time frame: Through study completion, up to 3 years
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
RECRUITINGMD Anderson
Houston, Texas, United States
RECRUITINGNEXT Oncology
San Antonio, Texas, United States
RECRUITINGNEXT Virginia
Fairfax, Virginia, United States
RECRUITINGPASO Medical
Frankston, Victoria, Australia
RECRUITINGChongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
RECRUITINGCancer Hospital of Shandong First Medical University(Shandong Cancer Institute, Shandong Cancer Hospital)
Jinan, Shandong, China
RECRUITINGFudan University Shanghai Cancer Center
Shanghai, China
RECRUITING