A First-in-human, Phase 1/2, Open-label, Multi-center, Dose-escalation, Dose-optimization, and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of PARP1 Selective Inhibitor, IMP1734, as Monotherapy in Patients With Advanced Solid Tumors
Summary
This study investigates the safety and tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of EIK1003 in participants with advanced solid tumors.
Detailed description
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.
Arms & interventions
- DrugIMP1734
PARP1 selective inhibitor
Outcome measures
Primary
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
Secondary
Pharmacokinetic parameters of IMP1734
Time frame: Through study completion, up to 3 years
Pharmacokinetic parameters of IMP1734
Time frame: Through study completion, up to 3 years
Pharmacokinetic parameters of IMP1734
Time frame: Through study completion, up to 3 years
Overall Response Rate
Time frame: Through study completion, up to 3 years
Eligibility criteria
Study locations (23)
The University of Arizona Cancer Center
Tucson, Arizona, 85719
University of Arkansas Winthrop P. Rockefeller Cancer Institute
Little Rock, Arkansas, 72205
Hoag Health Center Irvine
Irvine, California, 92618
University California Irvine
Irvine, California, 92868
Sharp Memorial Hospital
San Diego, California, 92123
University of California San Francisco (UCSF)
San Francisco, California, 94158
Sarah Cannon Research Institute Health One
Denver, Colorado, 80218
Smilow Cancer Hospital at Yale New Haven
New Haven, Connecticut, 06511
Advent Health Research Institute
Celebration, Florida, 34747
Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
Karmanos Cancer Institute
Detroit, Michigan, 48201
Henry Ford Health
Detroit, Michigan, 48202
University of Minnesota-Clinical Research Unit
Minneapolis, Minnesota, 55455
Washington University - Siteman Cancer Center
St Louis, Missouri, 63110
John Theurer Cancer Center
Hackensack, New Jersey, 07601
Cayuga Medical Center
Ithaca, New York, 14850
Lifespan Cancer Institute
Providence, Rhode Island, 02903
Medical University of South Carolina (MUSC) - Hollings CC
Charleston, South Carolina, 29425
West Cancer Center & Research Institute
Germantown, Tennessee, 38138
Sarah Cannon Research Institue Oncology
Nashville, Tennessee, 37203
START - South Texas Accelerated Research Therapeutics
San Antonio, Texas, 78229
START Mountain Region
West Valley City, Utah, 84119