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IMC-RON8 · 1 trial · 1 indication
The MTD was the previous dose level to that in which 2 of 6 participants experienced dose-limiting toxicities (DLTs). DLTs were defined as any of the following events: Grade 4 neutropenia lasting \>7 days; any Grade 3 or 4 neutropenia complicated by fever ≥38.5 degrees Celsius or infection, Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia complicated by hemorrhage; Grade 3 hepatic toxicity; or any Grade 3 or 4 nonhematologic toxicity (excluding alopecia, fatigue, anorexia, nausea, and vomiting that is controlled with antiemetics).
| Arm | Type | Description |
|---|---|---|
| IMC-RON8 | EXPERIMENTAL | A monoclonal antibody to human macrophage-stimulating 1-receptor-8 (RON8). |
| Name | Type | Description |
|---|---|---|
| IMC-RON8 | BIOLOGICAL | 5 milligrams per kilogram (mg/kg) intravenously (IV) Once a week for each 4-week treatment cycle, for a total of four doses per cycle. The initial 4-week treatment cycle will be followed by a 2-week observation period. Cohort 1 |
Inclusion Criteria: * The participant has histologically-confirmed advanced primary or recurrent solid tumors that have not responded to standard therapy or for which no standard therapy is available * The participant has measurable or non-measurable disease * The participant has not received major...
| 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 |
IMC-RON8 is an investigational monoclonal antibody being developed for the treatment of cancer. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being studied for safety and efficacy in patients.
IMC-RON8 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The company is conducting clinical trials to evaluate the drug's potential as a cancer treatment.
IMC-RON8 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The drug is being studied in early-stage trials to assess its safety, tolerability, and preliminary efficacy in patients with advanced solid tumors.
IMC-RON8 has been studied in one clinical trial, identified as NCT01119456, titled 'A Study of IMC-RON8 in Advanced Solid Tumors.' This Phase 1 trial was completed and enrolled 39 participants in the United States. The trial was uncontrolled, meaning there was no comparator group, and it was not randomized or double-blinded.
IMC-RON8 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The drug has not completed the clinical trials and regulatory review process required for approval, and its safety and efficacy have not been established for the treatment of cancer.