A Phase 1/2 interventional study of EIK1004-001 (IMP1707-001) in Advanced Solid Tumors, sponsored by Eikon Therapeutics. Recruiting at 10 sites in 3 countries. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2025-08-19.
Sponsored by Eikon Therapeutics · Phase 1/2, Interventional, and Treatment
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)
1,960 studies on the registry are indexed under Brain Neoplasms; 516 are open to participants now.
This study's planned enrollment of 130 is above the median of 40 across 1,458 interventional studies indexed under Brain Neoplasms.
Browse Brain Neoplasms studies →Eikon Therapeutics is the lead sponsor of 10 studies on the registry; 5 are open to participants now.
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mCRPC with ongoing ADT, must have received NHA and up to 1 prior line of taxane chemotherapy; Pancreatic cancer, must have prior 1L therapy
CNS Inclusion Criteria:
Key Exclusion Criteria:
Infections
- An active hepatitis B/C infection
CNS Exclusion Criteria
EIK1004 (IMP1707) monotherapy; oral tablet(s) daily (except for the single-dose period). Participants will receive escalating doses of EIK1004 (IMP1707) until progressive disease or discontinuation.
Drug: EIK1004-001 (IMP1707-001)
PARP1 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.
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
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.
Time frame: Through study completion, up to 3 years
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