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Also known as BTRC4017A, RO7227780
Runimotamab · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Dose Escalation | EXPERIMENTAL | Participants will be assigned sequentially to escalating doses of runimotamab up to the maximum tolerated dose (MTD). |
| Dose Expansion | EXPERIMENTAL | Participants will receive runimotamab based on the MTD or maximum allowed dose (MAD) identified during dose escalation. |
| Name | Type | Description |
|---|---|---|
| Runimotamab | DRUG | Runimotamab will be administered via IV infusion until disease progression, intolerable toxicity, or any other discontinuation criteria are met. |
| Trastuzumab | DRUG | Trastuzumab will be administered via IV infusion |
| Tocilizumab | DRUG | Participants will receive IV tocilizumab if needed |
Inclusion Criteria * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Life expectancy of at least 12 weeks * Adequate hematologic and end-organ function * Acute, clinically significant treatment-related toxicity from prior therapy must have resolved to Grade \</=1 prior to s...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
Runimotamab is an investigational monoclonal antibody being studied for the treatment of locally advanced or metastatic HER2-expressing cancers, including solid tumors. It is being developed by Roche Holding AG and is currently in Phase 1 clinical development. It is not yet approved for any indication.
Runimotamab is being developed by Roche Holding AG, which trades on the OTC market under the ticker RHHBY. Roche is the sponsor of the clinical program evaluating the antibody in HER2-expressing solid tumors.
Runimotamab is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA or any other regulatory authority. The single ongoing trial is currently active but no longer recruiting participants.
Runimotamab is being evaluated in one clinical trial, NCT03448042, titled A Study of Runimotamab in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers. The Phase 1 trial has enrolled 123 participants across the United States, Australia, Belgium, Canada, Denmark, France, Italy, Netherlands, Singapore, South Korea, Spain, Taiwan, and the United Kingdom.
Runimotamab is a monoclonal antibody designed to target HER2-expressing cancers. The Phase 1 trial enrolls participants with locally advanced or metastatic HER2-expressing solid tumors, and the study uses biomarker selection to identify patients whose tumors express HER2.
The Runimotamab Phase 1 trial NCT03448042 enrolls adults 18 years and older of any sex with locally advanced or metastatic HER2-expressing cancers. Healthy volunteers are not eligible. The study is controlled and biomarker-selected, and it is currently active but not recruiting new participants.