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RO5479599 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Part A: RO5479599 Dose Escalation | EXPERIMENTAL | Participants will receive a dose of 100 milligrams (mg) RO5479599 followed by dose escalation from Day 1 of Cycle 1. RO5479599 dose will be escalated as monotherapy in approximately 6 cohorts with dose increments between cohorts of up to 100 percent (%) until MTD. |
| Part B: RO5479599 Dose Escalation + Cetuximab | EXPERIMENTAL | Participants will receive RO5479599 in combination with cetuximab. Escalation of RO5479599 in combination with cetuximab will start in a standard 3+3 design until MTD/OBD is reached. If the initial combination is not tolerated, further cohorts will be dosed with the same dose of cetuximab and lower doses of RO5479599. |
| Part C: RO5479599 Dose Escalation + Erlotinib | EXPERIMENTAL | Participants will receive RO5479599 in combination with erlotinib. Escalation of RO5479599 in combination with erlotinib will start in a standard 3+3 design until MTD/OBD is reached. If the initial combination is not tolerated, further cohorts will be dosed with the same dose of erlotinib and lower doses of RO5479599. |
| Imaging (IMG) Substudy | EXPERIMENTAL | RO5479599 will be administered with zirconium- 89-labeled RO5479599. |
| Name | Type | Description |
|---|---|---|
| RO5479599 | DRUG | RO5479599 will be administered Q2W or Q3W (other regimen could be explored based on observations during dose escalation part). |
| Cetuximab | DRUG | Cetuximab will be administered via intravenous (IV) infusion at a starting dose of 400 mg/m\^2 for the first infusion, followed by doses of 250 mg/m\^2 for subsequent infusions. |
| Erlotinib | DRUG | Erlotinib, at a dose of 150 mg will be administered. |
| zirconium-89-labeled RO5479599 | DRUG | Single dose of radiolabeled drug will be administered. |
Inclusion Criteria: All Parts (A, B and C) * European Cooperative Oncology Group (ECOG) performance status 0-2 * Histologically confirmed metastatic and/or locally advanced malignant HER3-expressing solid tumors of epithelial origin * Availability of tissue and willingness to perform fresh pretrea...
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 |
RO5479599 is an investigational small molecule developed by Roche Holding AG for the treatment of neoplasms, specifically solid tumors of epithelial cell origin that express HER3. It is an oncology candidate and has been studied in a Phase 1 clinical trial. It is not an approved medicine.
RO5479599 was studied for use in patients with metastatic and/or locally advanced malignant solid tumors of epithelial cell origin that express HER3. The research focused on HER3 expressing neoplasms, and the compound was tested both as a single agent and in combination with cetuximab or erlotinib.
RO5479599 is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche sponsored the clinical research program for this small molecule oncology candidate.
RO5479599 is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are currently listed. The compound remains investigational and has not been approved by the FDA for any indication.
RO5479599 was evaluated in one Phase 1 trial, NCT01482377, titled a study of RO5479599 alone or in combination with cetuximab or erlotinib in participants with metastatic and/or locally advanced malignant HER3 expressing solid tumors of epithelial cell origin. The trial is completed and enrolled 145 participants across Denmark, the Netherlands, South Korea, and Spain.
RO5479599 is a small molecule studied in solid tumors that express HER3, also known as human epidermal growth factor receptor 3. The Phase 1 trial NCT01482377 selected participants based on HER3 expression, and the compound was tested alone and in combination with cetuximab or erlotinib.