Clinical Trials in Spain / NCT06586515
Recruiting
Phase 1
MOONRAY-01, A Study of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors
NCT06586515 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Pancreatic Ductal AdenocarcinomaNon-small Cell Lung CancerColorectal Cancer
Investigational drug(s) / intervention(s)
LY3962673Cetuximab →Gemcitabine →nab-paclitaxel →Oxaliplatin →leucovorin →Irinotecan →5-fluorouracil →
LY3962673: Administered orally.
Cetuximab: Administered intravenously.
Gemcitabine: Administered intravenously.
nab-paclitaxel: Administered intravenously.
Oxaliplatin: Administered intravenously.
leucovorin: Administered intravenously.
Irinotecan: Administered intravenously.
5-fluorouracil: Administered intravenously.
Study 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
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.
Primary outcome measure(s)
- Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration — Baseline through 5 years
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module. - Phase 1a: Number of Participants with DLT — During the first 28-day cycle of LY3962673 treatment
- Phase 1a: Number of Participants with DLT Equivalent Toxicities — During the first 28-day cycle of LY3962673 treatment
- Phase 1b: Overall Response Rate (ORR) — Up to approximately 5 years
ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) - Phase 1b: Best Overall Response (BOR) — Up to approximately 5 years
BOR per investigator assessed RECIST 1.1 - Phase 1b: Duration of Response (DOR) — Up to approximately 5 years
DOR per investigator assessed RECIST 1.1 - Phase 1b: Time to Response (TTR) — Up to approximately 5 years
TTR per investigator assessed RECIST 1.1 - Phase 1b: Disease Control Rate (DCR) — Up to approximately 5 years
DCR per investigator assessed RECIST 1.1
Trial sites (52)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
+ 12 more sites — see the full list on the official registry below.
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06586515 on ClinicalTrials.gov ↗ ← All trials in Spain