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LY2801653 · 3 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| LY2801653 Reference - Fasted | EXPERIMENTAL | Single oral dose of LY2801653 (Reference Formulation) administered in fasted state in one of three study periods. |
| LY2801653 Test - Fasted | EXPERIMENTAL | Single oral dose of LY2801653 (Test Formulation) administered in fasted state in one of three study periods. |
| LY2801653 Test - Fed | EXPERIMENTAL | Single oral dose of LY2801653 (Test Formulation) administered with a high fat meal in one of three study periods. |
| [^14C]-LY2801653 | EXPERIMENTAL | Single oral dose of LY2801653 containing 100 micro curies of radioactivity |
| LY2801653 | EXPERIMENTAL | This study consists of a dose escalation of LY2801653 (Part A) followed by dose confirmation cohorts in four tumor types (adenocarcinoma of the colon or rectum, head and neck squamous cell carcinoma, uveal melanoma with liver metastasis, and cholangiocarcinoma) (Part B). Part C consists of dose determination for LY2801653 in combination with cetuximab in participants with head and neck squamous cell carcinoma followed by an expansion cohort. Part D consists of dose determination for LY2801653 in combination with cisplatin in participants with cholangiocarcinoma followed by an expansion cohort. Part E consists of dose determination for LY2801653 in combination with gemcitabine and cisplatin. Part F consists of dose determination for LY2801653 in combination with ramicirumab. |
| Name | Type | Description |
|---|---|---|
| LY2801653 | DRUG | Administered orally |
| [^14C]-LY2801653 | DRUG | Administered orally |
| Cetuximab | DRUG | Cetuximab given via IV infusion once weekly, 400mg/m2 for first dose and 250mg /m2 for subsequent doses. If LY2801653 treatment is stopped due to toxicity after a minimum of 4 cycles, cetuximab may be continued until disease progression. In the event cetuximab treatment is stopped, participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion is met. |
| Cisplatin | DRUG | Cisplatin given via IV infusion once a week for 2 weeks and then every 3 weeks. If the LY2801653 is terminated for LY2801653-related toxicity after a minimum of 4 cycles, cisplatin may be continued as monotherapy until progression of disease. Participants discontinuing cisplatin therapy may be allowed to continue single agent LY2801653 if they are receiving clinical benefit. |
| Gemcitabine | DRUG | Gemcitabine given via IV infusion once a week for 2 weeks and then every 3 weeks. If the LY2801653 is terminated for LY2801653-related toxicity after a minimum of 4 cycles, gemcitabine may be continued as monotherapy until progression of disease. Participants discontinuing gemcitabine therapy may be allowed to continue single agent LY2801653 if they are receiving clinical benefit. |
| Ramucirumab | DRUG | Ramucirumab given via IV infusion every 2 weeks in a 28-day treatment cycle. Treatment with ramucirumab may continue until excessive toxicity or evidence of disease progression. In the absence of disease progression, treatment with LY2801653 may continue even if ramucirumab is discontinued provided no dose limiting toxicity related to LY2801653 is present. In the event that LY2801653 is discontinued, treatment with ramucirumab may be continued if there is no dose limiting toxicity related to ramucirumab. |
Inclusion Criteria: * Generally healthy sterile male and female participants * Body mass index (BMI) of 18.0 to 32.0 kilograms per square meter (kg/m\^2), inclusive * Are willing and able to eat the protocol specified high-fat breakfast Exclusion Criteria: * Have consumed grapefruits or grapefrui...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520/ GEH200521- Part A |
| Zimmer Biomet Holdings, Inc. | ZBH | 1 | - | Undisclosed |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |
LY2801653 is an investigational small molecule being studied for the treatment of advanced cancer. It has also been evaluated in healthy volunteers in early-stage clinical trials. As of the available data, LY2801653 is in Phase 1 clinical development and is not approved by the FDA.
LY2801653 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the NYSE under the ticker symbol LLY. The drug is currently in Phase 1 clinical trials, with studies conducted in the United States.
LY2801653 is in Phase 1 clinical development. It has completed three Phase 1 trials, including one in advanced cancer and two in healthy volunteers. The drug is investigational and has not received FDA approval.
LY2801653 has completed three Phase 1 trials: NCT01285037 in advanced cancer (190 participants), NCT01981408 in healthy volunteers (6 participants), and NCT02370485 in healthy participants unable to have children (23 participants). All trials were conducted in the United States.
LY2801653 is also known as merestinib. The drug is being developed by Eli Lilly and Company and has been studied in Phase 1 trials for advanced cancer and in healthy volunteers. It is an investigational small molecule and is not FDA approved.