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Also known as PLX3603
RO5212054 · 1 trial · 1 indication
Detailed timeframe: Pre-dose (0 hour \[hr\]): Day 1 of Cycles 1-10; Days 4, 8, 15 of Cycle 1. Post-dose: 1, 2, 4, 8, 12, 24 hr on Day 1 Cycle 1; Between 2-4 hr (1 sample) on Day 8 Cycle 1 and Day 1 Cycles 2-9; 1, 2, 4, 8, Between 10-12 hr (1 sample), 24 hr on Day 15 Cycle 1 (cycle length: 21 days)
Detailed timeframe: Pre-dose (0 hr): Day 1 of Cycles 1-10; Days 4, 8, 15 of Cycle 1. Post-dose: 1, 2, 4, 8, 12, 24 hr on Day 1 Cycle 1; Between 2-4 hr (1 sample) on Day 8 Cycle 1 and Day 1 Cycles 2-9; 1, 2, 4, 8, Between 10-12 hr (1 sample), 24 hr on Day 15 Cycle 1 (cycle length: 21 days)
Detailed timeframe: Pre-dose (0 hr): Day 1 of Cycles 1-10; Days 4, 8, 15 of Cycle 1. Post-dose: 1, 2, 4, 8, 12, 24 hr on Day 1 Cycle 1; Between 2-4 hr (1 sample) on Day 8 Cycle 1 and Day 1 Cycles 2-9; 1, 2, 4, 8, Between 10-12 hr (1 sample), 24 hr on Day 15 Cycle 1 (cycle length: 21 days)
| Arm | Type | Description |
|---|---|---|
| RO5212054: Continuous Dosing Cohort | EXPERIMENTAL | Participants will receive RO5212054 in escalating dose levels. |
| RO5212054: New Formulation (F05) Bridging Cohort | EXPERIMENTAL | Participants will receive RO5212054 as a single dose of new formulation (F05-150 mg film-coated tablet with different ratios of ingredients than F03 to increase bioavailability) and a single dose of current clinical Formulation (F03-150 mg film-coated tablet) in a cross-over manner. Participants will be alternately assigned to receive either F05 or F03 as their first dose, followed by the opposite Formulation as their second dose. Dose of RO5212054 will be decided based on the results of continuous dosing cohort. |
| Name | Type | Description |
|---|---|---|
| RO5212054 | DRUG | Participants will receive RO5212054 at a starting dose of 200 milligrams (mg) orally once daily in each 21 day cycle. Dose levels for escalation will be decided based on the safety assessment of previous cohort. Dose escalations in increments of 50-100 percent are planned. |
Inclusion Criteria: * Advanced solid tumor * Dose-escalation phase: Histologically confirmed, newly diagnosed or relapsed/ refractory unresectable American Joint Committee on Cancer (AJCC) Stage IIIC or IV disease * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Adequate liver, ...
Top 14 of 16 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 5 | PHASE3 | Luspatercept, Fedratinib, BMS-986158 |
| AbbVie, Inc. | ABBV | 4 | PHASE3 | Navitoclax, ABBV-744, IMGN632 |
| Novartis AG Sponsored ADR | NVS | 3 | PHASE3 | Pelabresib, Ruxolitinib |
| Karyopharm Therapeutics, Inc. | KPTI | 4 | PHASE3 | Selinexor |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 2 | PHASE3 | Elritercept |
| Geron Corporation | GERN | 2 | PHASE3 | Imetelstat |
| Incyte Corporation | INCY | 8 | PHASE2 | Ruxolitinib, INCB160058, INCB057643, INCA033989, INCA036978 |
| Merck & Co., Inc. | MRK | 1 | PHASE3 | Bomedemstat |
| GSK plc Sponsored ADR | GSK | 3 | PHASE2 | Momelotinib |
| Eli Lilly and Company | LLY | 2 | PHASE1 | LY3410738, LY5830966 |
| Disc Medicine, Inc. | IRON | 1 | PHASE1 | DISC-0974 |
| Damora Therapeutics, Inc. | DMRA | 2 | PHASE2 | GB2064, DMR-001 |
| Prelude Therapeutics, Inc. | PRLD | 1 | PHASE1 | PRT12396 |
| Syndax Pharmaceuticals Inc | SNDX | 1 | PHASE1 | Revumenib |
RO5212054 is an investigational small molecule developed by Roche Holding AG for the treatment of advanced solid tumors that carry a BRAF V600 mutation. It was studied in a Phase 1 clinical trial in participants with BRAF V600-mutated advanced solid tumors, a biomarker-selected oncology population.
RO5212054 was studied for use in neoplasms, specifically advanced solid tumors that test positive for a BRAF V600 mutation. The Phase 1 trial enrolled participants with these BRAF V600-mutated advanced solid tumors. It is an investigational agent and is not an approved therapy.
RO5212054 is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche sponsored the Phase 1 study of the compound in participants with BRAF V600-mutated advanced solid tumors.
RO5212054 is in Phase 1 development. Its single clinical trial, NCT01143753, has been completed, and no trials of the drug are currently active. It remains an investigational agent and is not approved for any indication.
RO5212054 was evaluated in one Phase 1 trial, NCT01143753, titled A Study of RO5212054 (PLX3603) in Participants With BRAF V600-Mutated Advanced Solid Tumors. The trial enrolled 45 participants across Australia, Denmark, and Spain and has been completed.
Yes. RO5212054 is also known as PLX3603. The Phase 1 trial of the compound is listed under both names, so searches for PLX3603 refer to the same investigational small molecule developed by Roche Holding AG for BRAF V600-mutated advanced solid tumors.