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Also known as LY2801653
Merestinib · 2 trials · 8 indications
Number of participants with DLTs
| Arm | Type | Description |
|---|---|---|
| Merestinib (Part A Dose Level 1) | EXPERIMENTAL | Merestinib administered orally. Treatment will continue until disease progression, development of unacceptable toxicity, or other discontinuation criteria are met. |
| Merestinib (Part A Dose Level 2) | EXPERIMENTAL | Merestinib administered orally. Treatment will continue until disease progression, development of unacceptable toxicity, or other discontinuation criteria are met. |
| Merestinib + Cisplatin + Gemcitabine (Part B) | EXPERIMENTAL | Merestinib administered orally with cisplatin and gemcitabine administered intravenously (IV). Treatment will continue until disease progression, development of unacceptable toxicity, or other discontinuation criteria are met, but Cisplatin and gemcitabine treatment will be limited to a maximum of 8 cycles. |
| 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 |
|---|---|---|
| Merestinib | DRUG | Administered orally |
| Cisplatin | DRUG | Administered IV |
| Gemcitabine | DRUG | Administered IV |
| LY2801653 | DRUG | LY2801653 given orally once daily during 28-day cycles. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion is met. |
| 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. |
| 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: * Part A: Histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic (solid tumors or non-Hodgkin's lymphoma). * Part B: Biliary tract carcinoma that is unresectable, recurrent, or metastatic. The participant must not have received prior sys...
Top 2 of 4 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520/GEH200521 |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |
Merestinib is an investigational small molecule being studied in advanced or metastatic cancer, including biliary tract carcinoma, cholangiocarcinoma, gall bladder carcinoma, solid tumors, and non-Hodgkin's lymphoma. It is not approved for any indication and remains in clinical development. The studied population was Japanese participants with advanced or metastatic disease.
Merestinib targets MET. It is a small molecule inhibitor of the MET receptor. By inhibiting MET, the drug is designed to interfere with signaling pathways involved in tumor growth and progression. This mechanism underlies its investigation in advanced solid tumors and lymphomas.
Merestinib is developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly is the sponsor of the clinical program evaluating the drug in advanced cancer. The compound is also identified by the code LY2801653.
Merestinib is in Phase 1 clinical development. It is investigational and has not been approved by the FDA or any other regulatory agency for any indication. The Phase 1 program has evaluated the drug in a small number of participants with advanced or metastatic cancer.
Merestinib has been evaluated in one completed Phase 1 trial, NCT03027284, titled A Study of Merestinib (LY2801653) in Japanese Participants With Advanced or Metastatic Cancer. That trial enrolled 19 participants in Japan and has completed. No active trials of Merestinib are currently listed.
Yes. Merestinib is also known by the development code LY2801653. Both names refer to the same investigational small molecule developed by Eli Lilly and Company. The Phase 1 trial NCT03027284 lists the drug under both names.