Evaluating LY3962673 for KRAS G12D-Mutant Solid Tumors
A Phase 1a/1b Trial of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors
This study is testing a new treatment called LY3962673 to see if it can help people with advanced solid tumors that have a specific KRAS G12D mutation.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 630 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 52 sites (Duarte, California and 51 other locations) |
| Trial ID | NCT06586515 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety, tolerability, and antitumor activity of LY3962673, both as a standalone treatment and in combination with other chemotherapy agents, for patients with advanced solid tumors harboring the KRAS G12D mutation. Participants will be monitored for their response to the treatment over a period of approximately five years. The study includes various solid tumor types, such as pancreatic ductal adenocarcinoma, non-small cell lung cancer, and colorectal cancer.
Who should consider this trial
Good fit: Ideal candidates are individuals with advanced solid tumors that have a confirmed KRAS G12D mutation and have previously received systemic chemotherapy.
Not a fit: Patients with active CNS metastases or significant unresolved toxicities from prior therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with KRAS G12D-mutant solid tumors, which are often difficult to treat.
How similar studies have performed: Other studies targeting KRAS mutations have shown promise, indicating potential for success with this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Duarte, California and 51 other locations
- City of Hope — Duarte, California, United States (Recruiting)
- University of California, Los Angeles (UCLA) — Santa Monica, California, United States (Recruiting)
- Sarah Cannon Research Institute at HealthOne — Denver, Colorado, United States (Recruiting)
- Sibley Memorial Hospital — Washington D.C., District of Columbia, United States (Recruiting)
- Florida Cancer Specialists - Lake Nona - Sarah Cannon Research Institute — Orlando, Florida, United States (Recruiting)
- Emory University School of Medicine — Atlanta, Georgia, United States (Recruiting)
- Community Health Network — Indianapolis, Indiana, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Not_yet_recruiting)
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
- Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States (Recruiting)
- South Texas Accelerated Research Therapeutics (START) Midwest — Grand Rapids, Michigan, United States (Recruiting)
- New York University (NYU) Langone Medical Center — New York, New York, United States (Recruiting)
- David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- Duke University Medical Center — Durham, North Carolina, United States (Recruiting)
- University of Cincinnati (UC) - Cancer Institute — Cincinnati, Ohio, United States (Recruiting)
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
- University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center — Pittsburgh, Pennsylvania, United States (Recruiting)
- Sarah Cannon Research Institute — Nashville, Tennessee, United States (Recruiting)
- USO - US Oncology Research Network — Nashville, Tennessee, United States (Recruiting)
- Vanderbilt University School of Medicine — Nashville, Tennessee, United States (Recruiting)
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- South Texas Accelerated Research Therapeutics (START) — San Antonio, Texas, United States (Recruiting)
- Huntsman Cancer Institute — Salt Lake City, Utah, United States (Recruiting)
- Fred Hutchinson Cancer Center — Seattle, Washington, United States (Recruiting)
- University of Wisconsin - Carbone Cancer Center — Madison, Wisconsin, United States (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 Hospita — Harbin, China (Not_yet_recruiting)
- Fudan University 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)
+2 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Email: LillyTrials@Lilly.com
- Phone: 1-317-615-4559
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.