Clinical trial · Interventional
MOONRAY-01, A Study of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors
A Phase 1a/1b Trial of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors
NCT06586515CI-TRIAL-00123403MOONRAY-01recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Pancreatic Ductal Adenocarcinoma | Pancreatic Ductal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-fluorouracil | Drug | Fluorouracil | ALIAS |
| Cetuximab | Drug | Cetuximab | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Irinotecan | Drug | Irinotecan | ALIAS |
| leucovorin | Drug | Leucovorin | ALIAS |
| LY3962673 | Drug | — | UNRESOLVED |
| nab-paclitaxel | Drug | Nab-paclitaxel | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Phase 1a: LY3962673 Dose Escalation
- description
- Escalating doses of LY3962673 administered orally.
- interventionNames
- Drug: LY3962673
- type
- EXPERIMENTAL
- label
- Phase 1b: LY3962673 Dose Expansion
- description
- LY3962673 administered orally either alone or in combination with other chemotherapy agents.
- interventionNames
- Drug: LY3962673
- Drug: Cetuximab
- Drug: Gemcitabine
- Drug: nab-paclitaxel
- Drug: Oxaliplatin
- Drug: leucovorin
- Drug: Irinotecan
- Drug: 5-fluorouracil
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.