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
Age ≥ 18 years at the time of informed consent
Eastern Cooperative Oncology Group (ECOG) performance status ≤1
Adequate organ function
Life expectancy ≥ 12 weeks
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
Sequential
EIK1004-001 (IMP1707-001)
DrugPARP1 selective inhibitor
Number 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.
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
Pharmacokinetic parameters of EIK1004 (IMP1707)
Peak plasma concentration (Cmax)
Pharmacokinetic parameters of EIK1004 (IMP1707)
Area under the curve (AUC) will be defined
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.
Pharmacodynamic changes due to EIK1004 (IMP1707)
Cytokines will be measured using an ELISA assay. The concentration of cytokines in plasma samples collected from patients is being measured and will be reported as a quantified value (e.g ng/mL). The fold change in plasma cytokines over baseline will be measured and the relative change compared to pre-dose/baseline numbers.
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Eikon Therapeutics
Lead sponsor
Impact Therapeutics, Inc.
Collaborator
