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
Status: Recruiting
Location: See all (24) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
This study will evaluate the preliminary efficacy of IMP1734 in patients with recurrent advanced/metastatic breast cancer, ovarian cancer and metastatic castrate resistant prostate cancer (mCRPC) with deleterious/suspected deleterious mutations of select homologous recombination repair (HRR) genes.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 89
Healthy Volunteers: f
View:
• Breast cancer; must have received at least one prior chemotherapy in neoadjuvant/adjuvant/metastatic setting, must have received hormonal therapy if HR+,
• HGSOC or high grade endometrioid EOC, fallopian tube or primary peritoneal cancer; must have received at least one prior platinum-based chemotherapy for advanced disease
• mCRPC with ongoing ADT, must have received NHA and up to 1 prior line of taxane chemotherapy
• Age ≥ 18 years at the time of informed consent
• Eastern Cooperative Oncology Group (ECOG) performance status ≤1
• Adequate organ function
• Life expectancy ≥ 12 weeks
• Should have evaluable disease as defined by RECIST1.1 and/or CA125 or PSA
• Female subjects of childbearing potential and male subjects must agree to use an effective method of contraception from study entry up to 6 months after the last dose of IMP1734
• deleterious or suspected deleterious germline or somatic mutations of select HRR genes
• up to 1 prior line of PARP inhibitor containing treatment
Locations
United States
California
University California Irvine
RECRUITING
Irvine
University of California San Francisco (UCSF)
RECRUITING
San Francisco
Colorado
Sarah Cannon Research Institute Health One
RECRUITING
Denver
Connecticut
Smilow Cancer Hospital at Yale New Haven
RECRUITING
New Haven
Florida
Advent Health Research Institute
RECRUITING
Celebration
Michigan
Karmanos Cancer Institute
RECRUITING
Detroit
Missouri
Washington University - Siteman Cancer Center
RECRUITING
St Louis
New York
Cayuga Medical Center
RECRUITING
Ithaca
South Carolina
Medical University of South Carolina (MUSC) - Hollings CC
RECRUITING
Charleston
Tennessee
Sarah Cannon Research Institue Oncology
RECRUITING
Nashville
Texas
START - South Texas Accelerated Research Therapeutics
RECRUITING
San Antonio
Utah
START Mountain Region
RECRUITING
West Valley City
Other Locations
Australia
Peninsula and south eastern haematology and oncology group
RECRUITING
Frankston
Scientia Clinical Research Ltd
RECRUITING
Randwick
Mater Cancer Care Centre, Mater Misericordiae Limited
NOT_YET_RECRUITING
South Brisbane
Gold Coast Private Hospital
RECRUITING
Southport
Macquarie University
RECRUITING
Sydney
Princess Alexandra Hospital
RECRUITING
Woolloongabba
China
Chongqing University Cancer Hospital
RECRUITING
Chongqing
Zhejiang Cancer Hospital
RECRUITING
Hangzhou
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Republic of Korea
Gachon University - Gil Medical Center
RECRUITING
Incheon
CHA Bundang Medical Center, CHA University
RECRUITING
Seongnam-si
Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
Contact Information
Primary
Ivan Sanchez
parpitrial@eikontx.com
341-777-0445
Time Frame
Start Date:2023-12-11
Estimated Completion Date:2026-12-01
Participants
Target number of participants:70
Treatments
Experimental: Cohort 1
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.