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 (54) 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
Arkansas
University of Arkansas Winthrop P. Rockefeller Cancer Institute
ENROLLING_BY_INVITATION
Little Rock
Arizona
The University of Arizona Cancer Center
RECRUITING
Tucson
California
Hoag Health Center Irvine
RECRUITING
Irvine
University California Irvine
RECRUITING
Irvine
Sharp Memorial Hospital
ENROLLING_BY_INVITATION
San Diego
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
Sylvester Comprehensive Cancer Center
ENROLLING_BY_INVITATION
Miami
Michigan
University of Michigan Rogel Cancer Center
ENROLLING_BY_INVITATION
Ann Arbor
Henry Ford Health
ENROLLING_BY_INVITATION
Detroit
Karmanos Cancer Institute
RECRUITING
Detroit
Minnesota
University of Minnesota-Clinical Research Unit
ENROLLING_BY_INVITATION
Minneapolis
Missouri
Washington University - Siteman Cancer Center
RECRUITING
St Louis
New Jersey
John Theurer Cancer Center
ENROLLING_BY_INVITATION
Hackensack
New York
Cayuga Medical Center
RECRUITING
Ithaca
Rhode Island
Lifespan Cancer Institute
RECRUITING
Providence
South Carolina
Medical University of South Carolina (MUSC) - Hollings CC
RECRUITING
Charleston
Tennessee
West Cancer Center & Research Institute
RECRUITING
Germantown
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
RECRUITING
South Brisbane
Gold Coast Private Hospital
RECRUITING
Southport
Macquarie University
RECRUITING
Sydney
Princess Alexandra Hospital
RECRUITING
Woolloongabba
Canada
Cross Cancer Institute
RECRUITING
Edmonton
Princess Margaret Cancer Centre-University Health Network
RECRUITING
Toronto
Sunnybrook Research Institute
RECRUITING
Toronto
BC Cancer Vancouver
ENROLLING_BY_INVITATION
Vancouver
China
Chongqing University Cancer Hospital
RECRUITING
Chongqing
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
Zhejiang Cancer Hospital
RECRUITING
Hangzhou
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Denmark
Righospitalet
RECRUITING
Copenhagen
France
CLCC François Baclesse
RECRUITING
Caen
Hospices Civils de Lyon - CHU Lyon Sud
RECRUITING
Pierre-bénite
Institut Gustave Roussy
RECRUITING
Villejuif
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
Spain
Hospital del Mar
RECRUITING
Barcelona
Vall d'Hebron Institute of Oncology
RECRUITING
Barcelona
Fundacion MD Anderson Cancer Center
RECRUITING
Madrid
Hospital Clinico San Carlos
RECRUITING
Madrid
START Madrid Fundación Jiménez Díaz
RECRUITING
Madrid
START-CIOCC HM Sanchinarro Hospital
RECRUITING
Madrid
Clínica Universidad de Navarra - Hospital
RECRUITING
Pamplona
Hospital Universitari Parc Taulí
RECRUITING
Sabadell
Universidad De Sevilla - Hospital Universitario Virgen Macarena
RECRUITING
Seville
Hospital Clinico Universitario de Valencia - INCLIVA
RECRUITING
Valencia
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.
Sponsors
Leads: Eikon Therapeutics
Collaborators: Impact Therapeutics, Inc.

This content was sourced from clinicaltrials.gov

Similar Clinical Trials