Clinical trial · Interventional
A Study of LY3499446 in Participants With Advanced Solid Tumors With KRAS G12C Mutation
A Phase 1/2 Study of LY3499446 Administered to Patients With Advanced Solid Tumors With KRAS G12C Mutation
NCT04165031CI-TRIAL-00055219terminatedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was terminated due to an unexpected toxicity finding.
Summary
Brief summary (as posted)
The reason for this study is to see if the study drug LY3499446 is safe and effective in participants with solid tumors with KRAS G12C mutation.
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 |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abemaciclib | Drug | Abemaciclib | ALIAS |
| Cetuximab | Drug | Cetuximab | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Erlotinib | Drug | Erlotinib | ALIAS |
| LY3499446 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- LY3499446 Phase 1 Cohort A1 High Dose
- description
- Participants received high dose LY3499446 as oral monotherapy twice daily (BID) in 21-day cycles.
- interventionNames
- Drug: LY3499446
- type
- EXPERIMENTAL
- label
- LY3499446 Phase 1 Cohort AO Mid Dose
- description
- Participant received mid dose LY3499446 as oral monotherapy once every other day (QOD) in 21-day cycles.
- interventionNames
- Drug: LY3499446
- type
- EXPERIMENTAL
- label
- LY3499446 Phase 1 Cohort A-2 Low Dose
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants must have diagnosis of a solid tumor with KRAS G12C mutation that did not respond to at least 1 line of standard therapy and has spread to other part(s) of the body * For phase II, participants must be willing to have new tumor tissue biopsies (doctor removes a small amount of tissue) during the study if it does not cause undue risks to health * Participants must be willing to use highly effective birth control * Participants must have adequate organ function * Participants must be able to swallow capsules Exclusion Criteria: * Participants must not have certain infections such as hepatitis or tuberculosis or HIV that is not well controlled * Participants must not have another serious medical condition including a serious heart condition, such as congestive heart failure, unstable angina pectoris, or heart attack within the last three months * Participants must not have cancer of the central nervous system that is not stable * Participants must not be pregnant or breastfeeding * Participants must not use herbal supplements
References
Publications (0)
Data not yet available
No reference posted for this study.