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Adjusted LOA
ML Risk
LY3214996 · 3 trials · 6 indications
Anti-tumor activity will be measured via disease control rate (DCR), which will be defined as the proportion of patients with complete response (CR), partial response (PR) or stable disease (SD) that persists for ≥ 4 months. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the diameters of target lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Toxicities occurring following administration of protocol therapy, measured using CTCAE 5.0 criteria.
| Arm | Type | Description |
|---|---|---|
| Safety Lead-In Cohort | EXPERIMENTAL | The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits. A treatment cycle will be defined as 28 consecutive days. Treatment will be administered on an outpatient basis. Test the safety of study drugs in combination and define dose levels. * LY3214996 * HCQ |
| LY3214996 and HCQ Combination | EXPERIMENTAL | The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits. A treatment cycle will be defined as 28 consecutive days. Treatment will be administered on an outpatient basis. Combined dosage per determined Lead-In Cohort * LY3214996 * HCQ |
| LY3214996-Monotherapy | EXPERIMENTAL | The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits. A treatment cycle will be defined as 28 consecutive days.Treatment will be administered on an outpatient basis. -LY3214996 |
| Cross Over Arm | EXPERIMENTAL | Participants who are enrolled to Arm 2 who experience radiologic disease progression on monotherapy will have the option to cross-over to receive treatment with the combination. Crossover will occur at the treating investigator's discretion following consultation and approval from the overall principal investigator. Combined dosage per determined Lead-In Cohort * LY3214996 * HCQ |
| Arm B: Dose Escalation LY3214996 | EXPERIMENTAL | -LY3214996 will be administered by mouth once daily continuously throughout each treatment cycle for patients with inhibitors for fungal prophylaxis/treatment |
| Arm A: Dose Expansion LY3214996 | EXPERIMENTAL | -LY3214996 will be administered by mouth once daily continuously throughout each treatment cycle for patients without inhibitors for fungal prophylaxis/treatment |
| LY3214996 Dose Escalation | EXPERIMENTAL | LY3214996 given orally once a day (or twice a day) for 21 days. |
| LY3214996 + Midazolam | EXPERIMENTAL | (Preliminary Drug-Drug Interactions \[DDI\]) LY3214996 given orally (once a day) and midazolam given orally on cycle 1 day 1 and cycle 1 day 16 (21 day cycles except cycle 1 only = 22 days). |
| LY3214996 Dose Expansion | EXPERIMENTAL | LY3214996 given orally (once a day) during each 21 day cycle. |
| LY3214996 + Abemaciclib | EXPERIMENTAL | Dose Escalation and Expansion- LY3214996 given orally (dose timing will be determined) and abemaciclib given orally (single dose given during lead in period) twice a day every 12 hours during 21 day cycle. |
| LY3214996 + Nab-Paclitaxel + Gemcitabine | EXPERIMENTAL | Dose Escalation and Expansion- LY3214996 given orally (dose timing will be determined) and nab-paclitaxel given intravenously (IV) on day 1, 8, and 15 and gemcitabine IV on day 1, 8, and 15 during each 28 day cycle. |
| LY3214996 + Encorafenib + Cetuximab | EXPERIMENTAL | Dose Escalation and Expansion- LY3214996 given orally, encorafenib given orally and cetuximab given IV. |
| Japan Part 1 | EXPERIMENTAL | LY3214996 given orally. |
| Japan Part 2 | EXPERIMENTAL | LY3214996 given orally and abemaciclib given orally. |
| Name | Type | Description |
|---|---|---|
| Hydroxychloroquine Sulfate | DRUG | HCQ will be administered by mouth twice daily continuously throughout each treatment per 28 day cycle |
| LY3214996 | DRUG | LY3214996-daily oral dosage per protocol per 28 day cycle |
| Midazolam | DRUG | Administered orally |
| Abemaciclib | DRUG | Administered orally |
| Nab-paclitaxel | DRUG | Administered IV |
| Gemcitabine | DRUG | Administered IV |
| Encorafenib | DRUG | Administered orally |
| Cetuximab | DRUG | Administered IV |
Inclusion Criteria: * Participants must have histologically or cytologically confirmed adenocarcinoma or poorly differentiated carcinoma of the pancreas. * Age ≥ 18 years. * ECOG performance status ≤ 1 * Participants must have measurable disease, defined as at least one lesion that can be accuratel...
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LY3214996 is an investigational small molecule developed by Eli Lilly and Company for oncology indications. It has been studied in acute myeloid leukemia, advanced cancer, and pancreatic cancer. It is not an approved therapy and remains in clinical development, with completed Phase 1 and Phase 2 trials in these patient populations.
LY3214996 was studied in pancreatic cancer and advanced cancer in a completed Phase 2 trial, NCT04386057, which tested LY3214996 with or without hydroxychloroquine. That trial enrolled 52 participants in the United States. LY3214996 is investigational and has not been approved for pancreatic cancer or any other indication.
Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY, is the developer of LY3214996. The company sponsored the clinical trials evaluating the compound in acute myeloid leukemia, pancreatic cancer, and advanced solid tumors.
LY3214996 has been evaluated in Phase 1 and Phase 2 clinical trials, and all of those trials are now completed. The program includes a Phase 1 study in acute myeloid leukemia and a Phase 2 study in pancreatic cancer. LY3214996 is investigational and is not FDA approved.
Three completed trials have evaluated LY3214996: NCT02857270, a Phase 1 study in advanced or metastatic cancer with 210 participants across the United States, Australia, France, and Japan; NCT04081259, a Phase 1 study in acute myeloid leukemia with 17 participants; and NCT04386057, a Phase 2 study in pancreatic cancer with 52 participants.
LY3214996 has been studied in acute myeloid leukemia, pancreatic cancer, advanced cancer, metastatic melanoma, metastatic non-small cell lung cancer, and colorectal cancer. These indications were evaluated across three completed clinical trials sponsored by Eli Lilly and Company. The compound remains investigational, and no approved indication exists for it.