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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...
| 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 |
RO5479599 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 metastatic and/or locally advanced malignant solid tumors of epithelial cell origin that express human epidermal growth factor receptor 3 (HER3).
RO5479599 targets human epidermal growth factor receptor 3 (HER3), a protein involved in cell growth and survival that is often overexpressed in certain solid tumors. By targeting HER3, the drug aims to interfere with tumor growth in cancers of epithelial cell origin.
RO5479599 is being developed by Roche Holding AG, a multinational healthcare company headquartered in Switzerland. Roche's stock is traded on the OTC market under the ticker symbol RHHBY.
RO5479599 is in Phase 1 clinical development. It has completed one Phase 1 trial, and there are no active trials currently ongoing. The drug remains investigational and has not been approved by regulatory authorities for any use.
RO5479599 has been studied in one completed clinical trial, registered as NCT01482377. This Phase 1 study evaluated the drug 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 enrolled 145 participants across Denmark, Netherlands, South Korea, and Spain.
RO5479599 is a small molecule, not an antibody. It was studied in combination with cetuximab and erlotinib, which are targeted therapies for certain cancers. The drug is designed to target HER3, but its mechanism as a small molecule differs from that of monoclonal antibodies.