Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RO5458640 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Single Arm | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| RO5458640 | DRUG | Multiple ascending doses intravenously, weekly or every 2 weeks or every 3 weeks |
Inclusion Criteria: * Adult patients, \>/= 18 years of age * Histologically or cytologically confirmed malignant solid tumors * Measurable and/or evaluable disease according to RECIST 1.1 criteria * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Adequate bone marrow, liver an...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 5 | PHASE3 | ACE-536 |
| AbbVie, Inc. | ABBV | 4 | PHASE3 | Navitoclax, Ruxolitinib |
| Novartis AG Sponsored ADR | NVS | 3 | PHASE3 | Pelabresib, Ruxolitinib |
| Karyopharm Therapeutics, Inc. | KPTI | 4 | PHASE3 | Selinexor, Ruxolitinib |
| Geron Corporation | GERN | 2 | PHASE3 | Imetelstat |
| Merck & Co., Inc. | MRK | 1 | PHASE3 | Bomedemstat |
| Incyte Corporation | INCY | 10 | PHASE2 | Ruxolitinib |
| GSK plc Sponsored ADR | GSK | 2 | PHASE2 | MMB |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 1 | PHASE2 | Elritercept, Ruxolitinib |
| Eli Lilly and Company | LLY | 1 | PHASE1 | LY3410738, Venetoclax, Azacitidine |
| Disc Medicine, Inc. | IRON | 1 | PHASE1 | DISC-0974 |
| Galecto, Inc. | GLTO | 1 | PHASE2 | GB2064 |
| Prelude Therapeutics, Inc. | PRLD | 1 | PHASE1 | PRT12396 |
| United Therapeutics Corporation | UTHR | 1 | PHASE2 | bomedemstat |
RO5458640 is an investigational small molecule being studied for the treatment of neoplasms, which are abnormal growths of tissue that can be benign or malignant. It was evaluated in patients with advanced solid tumors, a type of cancer. The drug is in Phase 1 clinical development and is not yet approved.
RO5458640 is being developed by Roche Holding AG, a multinational healthcare company. Roche's stock is traded under the ticker symbol RHHBY. The company was conducting clinical research on this investigational oncology drug.
RO5458640 is in Phase 1 clinical development. It has completed one Phase 1 trial, which was an uncontrolled, non-randomized study in patients with advanced solid tumors. The drug is still investigational and has not been approved by regulatory authorities.
RO5458640 has been studied in one clinical trial, identified as NCT01383733. This was a Phase 1 study titled 'A Study of RO5458640 in Patients With Advanced Solid Tumors.' The trial was completed and enrolled 54 participants across Canada, Denmark, and the Netherlands.
No, RO5458640 is not FDA approved. It is an investigational drug that has completed Phase 1 clinical development. The drug is still in the research phase and has not been authorized for use in patients outside of clinical trials.