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

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.

Interventions

• LY3962673 · DRUG

  Administered orally.

• Cetuximab · DRUG

  Administered intravenously.

• Gemcitabine · DRUG

  Administered intravenously.

• nab-paclitaxel · DRUG

  Administered intravenously.

• Oxaliplatin · DRUG

  Administered intravenously.

• leucovorin · DRUG

  Administered intravenously.

• Irinotecan · DRUG

  Administered intravenously.

• 5-fluorouracil · DRUG

  Administered intravenously.

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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.

Sites (52)

• City of Hope, Duarte, California · RECRUITING
• University of California, Los Angeles (UCLA), Santa Monica, California · RECRUITING
• Sarah Cannon Research Institute at HealthOne, Denver, Colorado · RECRUITING
• Sibley Memorial Hospital, Washington D.C., District of Columbia · RECRUITING
• Florida Cancer Specialists - Lake Nona - Sarah Cannon Research Institute, Orlando, Florida · RECRUITING
• Emory University School of Medicine, Atlanta, Georgia · RECRUITING
• Community Health Network, Indianapolis, Indiana · RECRUITING
• Massachusetts General Hospital, Boston, Massachusetts · NOT_YET_RECRUITING
• Dana-Farber Cancer Institute, Boston, Massachusetts · RECRUITING
• Barbara Ann Karmanos Cancer Institute, Detroit, Michigan · RECRUITING
• South Texas Accelerated Research Therapeutics (START) Midwest, Grand Rapids, Michigan · RECRUITING
• New York University (NYU) Langone Medical Center, New York, New York · RECRUITING
• David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center, New York, New York · RECRUITING
• Duke University Medical Center, Durham, North Carolina · RECRUITING
• University of Cincinnati (UC) - Cancer Institute, Cincinnati, Ohio · RECRUITING
• Cleveland Clinic, Cleveland, Ohio · RECRUITING
• University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center, Pittsburgh, Pennsylvania · RECRUITING
• Sarah Cannon Research Institute, Nashville, Tennessee · RECRUITING
• USO - US Oncology Research Network, Nashville, Tennessee · RECRUITING
• Vanderbilt University School of Medicine, Nashville, Tennessee · RECRUITING
• MD Anderson Cancer Center, Houston, Texas · RECRUITING
• South Texas Accelerated Research Therapeutics (START), San Antonio, Texas · RECRUITING
• Huntsman Cancer Institute, Salt Lake City, Utah · RECRUITING
• Fred Hutchinson Cancer Center, Seattle, Washington · RECRUITING
• University of Wisconsin - Carbone Cancer Center, Madison, Wisconsin · RECRUITING
• The Ottawa Hospital, Ottawa, Canada · RECRUITING
• Princess Margaret Hospital, Toronto, Canada · RECRUITING
• Cancer Institute & Hospital, Chinese Academy of Medical Sciences, Beijing, China · NOT_YET_RECRUITING
• Beijing Cancer hospital, Beijing, China · NOT_YET_RECRUITING
• Harbin Medical University Cancer Hospital, Harbin, China · NOT_YET_RECRUITING
• Fudan University Shanghai Cancer Center, Shanghai, China · NOT_YET_RECRUITING
• Centre Leon Berard, Lyon, France · NOT_YET_RECRUITING
• Centre d'Essais Precoces en Cancerologie de Marseille (CEPCM) - AP-HM Hopital de La Timone, Marseille, France · NOT_YET_RECRUITING
• Oncopole Claudius Regaud, Toulouse, France · NOT_YET_RECRUITING
• Institut Gustave Roussy, Villejuif, France · NOT_YET_RECRUITING
• Charite Universitaetsmedizin Berlin, Berlin, Germany · RECRUITING
• Universitaetsklinikum Carl Gustav Carus Dresden, Dresden, Germany · RECRUITING
• Universitaetsklinikum Essen, Essen, Germany · RECRUITING
• Klinikum der Ludwig-Maximilians-Universitaet Muenchen, München, Germany · RECRUITING
• START Dublin Early Phase Clinical Trials Unit, Dublin, Ireland · RECRUITING
• Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli, Naples, Italy · RECRUITING
• UOC Fase I - Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore, Roma, Italy · RECRUITING
• Centro Ricerche Cliniche di Verona s.r.l., Verona, Italy · RECRUITING
• National Cancer Center Hospital East, Chiba, Japan · RECRUITING
• Kanagawa cancer center, Kanagawa, Japan · RECRUITING
• Aichi Cancer Center Hospital, Nagoya, Japan · RECRUITING
• Kansai Medical University Hospital, Osaka, Japan · RECRUITING
• National Cancer Center Hospital, Tokyo, Japan · RECRUITING
• South Texas Accelerated Research Therapeutics (START) Barcelona- HM Nou Delfos, Barcelona, Spain · RECRUITING
• Hospital Universitario Vall d'Hebron, Barcelona, Spain · RECRUITING
• South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz, Madrid, Spain · RECRUITING
• Hospital Universitario 12 de Octubre, Madrid, Spain · RECRUITING