A Phase 1/2, Open-label, Multicenter, Dose-escalation, and Dose-Optimization Study to Evaluate the Safety, Tolerability, and Activity of EIK1004 (IMP1707) as Monotherapy in Participants With Advanced Solid Tumors
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 89
Healthy Volunteers: f
View:
• Untreated CNS metastases (measurable and/or non-measurable) not needing immediate local therapy.
• Previously treated CNS metastases
Locations
United States
Colorado
Sarah Cannon Research Institute at HealthOne
RECRUITING
Denver
Florida
Florida Cancer Center
RECRUITING
Lake Mary
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Texas
MD Anderson
RECRUITING
Houston
NEXT Oncology
RECRUITING
San Antonio
Virginia
NEXT Virginia
RECRUITING
Fairfax
Other Locations
Australia
PASO Medical
RECRUITING
Frankston
China
Chongqing University Cancer Hospital
RECRUITING
Chongqing
Cancer Hospital of Shandong First Medical University(Shandong Cancer Institute, Shandong Cancer Hospital)
RECRUITING
Jinan
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Contact Information
Primary
Sunny Chaudry, MS
chaudrys@eikontx.com
6319026200
Time Frame
Start Date: 2025-04-30
Estimated Completion Date: 2028-12
Participants
Target number of participants: 130
Treatments
Experimental: Part 1
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.
Related Therapeutic Areas
Sponsors
Leads: Eikon Therapeutics
Collaborators: Impact Therapeutics, Inc.