A Phase 1a/1b Trial of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors
Status: Recruiting
Location: See all (52) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
The main purpose of this study is to assess safety \& tolerability and antitumor activity of LY3962673 as monotherapy and in combination with other chemotherapy agents in participants with KRAS G12D-mutant advanced solid tumor types. The study is expected to last approximately 5 years.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Have Histological or cytologically proven diagnosis of locally advanced, unresectable, and/or metastatic cancer and measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
• Have evidence of KRAS G12D mutation in tumor tissue or circulating tumor DNA
• Have an ECOG performance status of ≤ 1
• Must have received ≥ 1 prior line of systemic chemotherapy for advanced or metastatic disease
• Participants with asymptomatic or treated CNS disease may be eligible.
Locations
United States
California
City of Hope
RECRUITING
Duarte
University of California, Los Angeles (UCLA)
RECRUITING
Los Angeles
Colorado
Sarah Cannon Research Institute at HealthOne
RECRUITING
Denver
Washington, D.c.
Sibley Memorial Hospital
RECRUITING
Washington D.c.
Florida
Florida Cancer Specialists - Lake Nona - Sarah Cannon Research Institute
RECRUITING
Orlando
Georgia
Emory University School of Medicine
RECRUITING
Atlanta
Indiana
Community Health Network
RECRUITING
Indianapolis
Massachusetts
Dana-Farber Cancer Institute
RECRUITING
Boston
Massachusetts General Hospital
NOT_YET_RECRUITING
Boston
Michigan
Barbara Ann Karmanos Cancer Institute
RECRUITING
Detroit
South Texas Accelerated Research Therapeutics (START) Midwest
RECRUITING
Grand Rapids
North Carolina
Duke University Medical Center
RECRUITING
Durham
New York
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
RECRUITING
New York
New York University (NYU) Langone Medical Center
RECRUITING
New York
Ohio
University of Cincinnati (UC) - Cancer Institute
RECRUITING
Cincinnati
Cleveland Clinic
RECRUITING
Cleveland
Pennsylvania
University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center
RECRUITING
Pittsburgh
Tennessee
Sarah Cannon Research Institute
RECRUITING
Nashville
USO - US Oncology Research Network
RECRUITING
Nashville
Vanderbilt University School of Medicine
RECRUITING
Nashville
Texas
MD Anderson Cancer Center
RECRUITING
Houston
South Texas Accelerated Research Therapeutics (START)
RECRUITING
San Antonio
Utah
Huntsman Cancer Institute
RECRUITING
Salt Lake City
Washington
Fred Hutchinson Cancer Center
RECRUITING
Seattle
Wisconsin
University of Wisconsin - Carbone Cancer Center
RECRUITING
Madison
Other Locations
Canada
The Ottawa Hospital
RECRUITING
Ottawa
Princess Margaret Hospital
RECRUITING
Toronto
China
Beijing Cancer hospital
NOT_YET_RECRUITING
Beijing
Cancer Institute & Hospital, Chinese Academy of Medical Sciences
NOT_YET_RECRUITING
Beijing
Harbin Medical University Cancer Hospita
NOT_YET_RECRUITING
Harbin
Fudan University Cancer Center
NOT_YET_RECRUITING
Shanghai
France
Centre Leon Berard
NOT_YET_RECRUITING
Lyon
Centre d'Essais Precoces en Cancerologie de Marseille (CEPCM) - AP-HM Hopital de La Timone
NOT_YET_RECRUITING
Marseille
Oncopole Claudius Regaud
NOT_YET_RECRUITING
Toulouse
Institut Gustave Roussy
NOT_YET_RECRUITING
Villejuif
Germany
Charite Universitaetsmedizin Berlin
RECRUITING
Berlin
Universitaetsklinikum Carl Gustav Carus Dresden
RECRUITING
Dresden
Universitaetsklinikum Essen
RECRUITING
Essen
Klinikum der Ludwig-Maximilians-Universitaet Muenchen
RECRUITING
München
Ireland
START Dublin Early Phase Clinical Trials Unit
RECRUITING
Dublin
Italy
Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli
RECRUITING
Napoli
UOC Fase I - Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
RECRUITING
Roma
Centro Ricerche Cliniche di Verona s.r.l.
RECRUITING
Verona
Japan
National Cancer Center Hospital East
RECRUITING
Chiba
Kanagawa cancer center
RECRUITING
Kanagawa
Aichi Cancer Center Hospital
RECRUITING
Nagoya
Kansai Medical University Hospital
RECRUITING
Osaka
National Cancer Center Hospital
RECRUITING
Tokyo
Spain
Hospital Universitario Vall d'Hebron
RECRUITING
Barcelona
South Texas Accelerated Research Therapeutics (START) Barcelona- HM Nou Delfos
RECRUITING
Barcelona
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz
RECRUITING
Madrid
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
1-317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date: 2024-09-12
Estimated Completion Date: 2029-03
Participants
Target number of participants: 630
Treatments
Experimental: Phase 1a: LY3962673 Dose Escalation
Escalating doses of LY3962673 administered orally.
Experimental: Phase 1b: LY3962673 Dose Expansion
LY3962673 administered orally either alone or in combination with other chemotherapy agents.
Experimental: Experimental: Phase 1a: LY3962673 Monotherapy
LY3962673 administered orally
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company