A Phase 1/2 interventional study of IMP1734 in Advanced Solid Tumor, sponsored by Eikon Therapeutics. Recruiting at 57 sites in 8 countries. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-06-15.
Sponsored by Eikon Therapeutics · Phase 1/2, Interventional, and Treatment
This study investigates the safety and tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of EIK1003 in participants with advanced solid tumors.
This study will evaluate the safety, tolerability and preliminary efficacy of IMP1734 as monotherapy in patients with recurrent, advanced/metastatic solid tumors. This study includes 2 parts: Part 1 and Part 2. Part 1 includes a monotherapy dose escalation of EIK1003 followed by combination dose escalations in metastatic prostate cancer (mPC), ovarian and breast cancer.
Part 1, dose escalation, the study will identify the maximum tolerated dose (MTD) or maximum achievable dose (MAD) in solid tumor.
Part 2 will explore dose optimization with selection of an optimal dose for future clinical development of EIK1003.
Eikon Therapeutics is the lead sponsor of 10 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria
Key Exclusion Criteria:
Infections
- An active hepatitis B/C infection
IMP1734 monotherapy; oral tablet(s) daily (except for the single-dose period). The maximum trial duration is 3 years after the last participant's first treatment in the trial.
Drug: IMP1734
PARP1 selective inhibitor
Number of subjects with adverse events, treatment emergent adverse events or serious adverse events
Number of subjects 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: Consent to 30 + 7 days post last dose of IMP1734
Maxim Tolerated Dose or Recommended Dose for Expansion
Number of patients that experience a DLT or any toxicity which occurs from the time of the first dose of study drug until the end of cycle 1, which is deemed unrelated to the disease.
Time frame: DLT period is from the first dose of the study drug until the last day of the first cycle
Pharmacokinetic parameters of IMP1734
Peak plasma concentration (Cmax)
Time frame: Through study completion, up to 3 years
Pharmacokinetic parameters of IMP1734
Time to peak drug concentration (Tmax)
Time frame: Through study completion, up to 3 years
Pharmacokinetic parameters of IMP1734
Area under the curve (AUC) will be defined
Time frame: Through study completion, up to 3 years
Overall Response Rate
Percentage of participants who have CR/PR per RECIST v1.1,and/or CA125 response per GCIG criteria (ovarian cancer), and/or PSA response per PCWG3 criteria
Time frame: Through study completion, up to 3 years
Characterization of the pharmacodynamic changes due to IMP1734
Evaluation of serial pharmacodynamic changes across multiple doses of IMP1734
Time frame: Through study completion, up to 3 years
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Eikon Therapeutics