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Study of EIK1004 IMP1707 as a Daily Oral Treatment for Advanced Solid Tumors Including Breast, Ovarian, Prostate, and Pancreatic Cancer Phase 12 Dose Escalation and Optimization to Evaluate Safety and Effectiveness
Led by Eikon Therapeutics · Updated on 2025-08-19
130
Participants Needed
10
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and preliminary effectiveness of EIK1004 IMP1707, a PARP1 selective inhibitor, in adults with advanced solid tumors including recurrent advancedmetastatic breast cancer, ovarian cancer, metastatic castrate resistant prostate cancer mCRPC, and pancreatic cancer. These participants must have mutations in select homologous recombination repair HRR genes. The study is a Phase 12 open-label trial sponsored by Eikon Therapeutics. The study has two parts dose escalation and dose optimization. In the dose escalation phase, participants receive escalating oral doses of EIK1004 daily except during a single-dose period to find the highest tolerated or achievable dose. The dose optimization phase further evaluates safety, tolerability, how the drug moves and acts in the body, and anti-tumor effects at selected doses. Participants will be monitored closely with assessments including adverse event tracking up to one month after the last dose, and pharmacokinetic evaluations up to three years. The main outcomes include the number of participants experiencing dose-limiting toxicities and other adverse events. Participants must have evaluable disease and meet specific health and organ function requirements. The total study participation duration varies, with follow-up extending up to three years for some measures.
CONDITIONS
Brief Title
A Study of PARP1 Selective Inhibitor, EIK1004 (IMP1707) in Participants With Advanced Solid Tumors.
Research Team
S
Sunny Chaudry, MS
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