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Recruiting Phase 1 NCT06586515

MOONRAY-01, A Study of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors

Phase 1 – testing safety in a small group of people
Conditions: Pancreatic Ductal Adenocarcinoma Non-small Cell Lung Cancer Colorectal Cancer

Sponsor: Eli Lilly and Company

trial.available_in: БГ
Overview
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.
Who can participate
Inclusion Criteria: * 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. Exclusion Criteria: * Have known active CNS metastases and/or carcinomatous meningitis. * Have any unresolved toxicities from prior therapy greater than National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grade 1. * Have significant cardiovascular disease as unstable angina or acute coronary syndrome, history of myocardial infarction, known reduced left ventricular ejection fraction. * Have active uncontrolled systemic bacterial, viral, fungal, or parasitic infection. * Have known active hepatitis B virus (HBV) and hepatitis C virus (HCV). * Have other active malignancy unless in remission with life expectancy greater than (\>) 2 years.
Interventions
LY3962673
DRUG
Cetuximab
DRUG
Gemcitabine
DRUG
nab-paclitaxel
DRUG
Oxaliplatin
DRUG
leucovorin
DRUG
Irinotecan
DRUG
5-fluorouracil
DRUG
Locations 52
Canada (2)
The Ottawa Hospital
Ottawa
Princess Margaret Hospital
Toronto
China (4)
Cancer Institute & Hospital, Chinese Academy of Medical Sciences
Beijing
NOT_YET_RECRUITING
Beijing Cancer hospital
Beijing
NOT_YET_RECRUITING
Harbin Medical University Cancer Hospita
Harbin
NOT_YET_RECRUITING
Fudan University Cancer Center
Shanghai
NOT_YET_RECRUITING
France (4)
Centre Leon Berard
Lyon
NOT_YET_RECRUITING
Centre d'Essais Precoces en Cancerologie de Marseille (CEPCM) - AP-HM Hopital de La Timone
Marseille
NOT_YET_RECRUITING
Oncopole Claudius Regaud
Toulouse
NOT_YET_RECRUITING
Institut Gustave Roussy
Villejuif
NOT_YET_RECRUITING
Germany (4)
Charite Universitaetsmedizin Berlin
Berlin
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden
Universitaetsklinikum Essen
Essen
Klinikum der Ludwig-Maximilians-Universitaet Muenchen
München
Ireland (1)
START Dublin Early Phase Clinical Trials Unit
Dublin
Italy (3)
Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli
Naples
UOC Fase I - Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
Roma
Centro Ricerche Cliniche di Verona s.r.l.
Verona
Japan (5)
National Cancer Center Hospital East
Chiba
Kanagawa cancer center
Kanagawa
Aichi Cancer Center Hospital
Nagoya
Kansai Medical University Hospital
Osaka
National Cancer Center Hospital
Tokyo
Spain (4)
South Texas Accelerated Research Therapeutics (START) Barcelona- HM Nou Delfos
Barcelona
Hospital Universitario Vall d'Hebron
Barcelona
South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz
Madrid
Hospital Universitario 12 de Octubre
Madrid
United States (25)
Emory University School of Medicine
Atlanta , Georgia
Massachusetts General Hospital
Boston , Massachusetts
NOT_YET_RECRUITING
Dana-Farber Cancer Institute
Boston , Massachusetts
University of Cincinnati (UC) - Cancer Institute
Cincinnati , Ohio
Cleveland Clinic
Cleveland , Ohio
Sarah Cannon Research Institute at HealthOne
Denver , Colorado
Barbara Ann Karmanos Cancer Institute
Detroit , Michigan
City of Hope
Duarte , California
Duke University Medical Center
Durham , North Carolina
South Texas Accelerated Research Therapeutics (START) Midwest
Grand Rapids , Michigan
MD Anderson Cancer Center
Houston , Texas
Community Health Network
Indianapolis , Indiana
University of Wisconsin - Carbone Cancer Center
Madison , Wisconsin
Sarah Cannon Research Institute
Nashville , Tennessee
USO - US Oncology Research Network
Nashville , Tennessee
Vanderbilt University School of Medicine
Nashville , Tennessee
New York University (NYU) Langone Medical Center
New York , New York
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York , New York
Florida Cancer Specialists - Lake Nona - Sarah Cannon Research Institute
Orlando , Florida
University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center
Pittsburgh , Pennsylvania
Huntsman Cancer Institute
Salt Lake City , Utah
South Texas Accelerated Research Therapeutics (START)
San Antonio , Texas
University of California, Los Angeles (UCLA)
Santa Monica , California
Fred Hutchinson Cancer Center
Seattle , Washington
Sibley Memorial Hospital
Washington D.C. , District of Columbia
Technical details
Status
Recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
12.09.2024
Completion date
01.03.2029
Registry ID
NCT06586515
Source
clinicaltrials.gov
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