Approval Probability
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Also known as Selicrelumab
RO7009789 · 2 trials · 2 indications
From D1 until D28 of C1 (cycle length=28 days)
From D1 until D28 of C1 (cycle length=28 days)
From D1 of C1 until treatment discontinuation and approximately 45 days after last dose (cycle length=28 days)
From D1 of C1 through safety follow up visit (45 days post final dose; Cycle = 28 days)
Tumor assessments at Screening and on D1 of C3, C5, C7; and every 12 weeks thereafter until disease progression (cycle length=28 days)
Tumor assessments at Screening and on D1 of C3, C5, C7; and every 12 weeks thereafter until disease progression (cycle length=28 days)
Tumor assessments at Screening and on D1 of C3, C5, C7; and every 12 weeks thereafter until disease progression (cycle length=28 days)
Tumor assessments at Screening and on D1 of C3, C5, C7; and every 12 weeks thereafter until disease progression (cycle length=28 days)
| Arm | Type | Description |
|---|---|---|
| Part I (Dose-Finding Stage) | EXPERIMENTAL | Emactuzumab and RO7009789 will be administered intravenously (IV) at a starting dose of 500 milligrams (mg) for emactuzumab and 2 mg for RO7009789. Treatment will continue as long as there is clinical benefit until unacceptable toxicity, symptomatic deterioration, or withdrawal of consent. |
| Part II (Dose Expansion Stage) | EXPERIMENTAL | Emactuzumab and RO7009789 will be administered IV at the maximum tolerated dose defined in Part I of the study. Treatment will continue as long as there is clinical benefit until unacceptable toxicity, symptomatic deterioration, or withdrawal of consent. |
| Part I: Selicrelumab, Vanucizumab/Bevacizumab | EXPERIMENTAL | Participants will receive a fixed dose of vanucizumab, 2 grams via IV infusion on Days 1 and 15 of every 28-day cycle. Selicrelumab will be given SC in ascending dose levels on Day 2 of Cycles 1 to 4 and every third cycle thereafter. Treatment will continue as long as the participant experiences clinical benefit or until unacceptable toxicity, withdrawal of consent, or the end of Part I of the study (expected 24 months). Due to the discontinuation of Vanucizumab development, Participants ongoing in Part I will switch from Vanucizumab to Bevacizumab. All the dose escalation has been performed using Vanucizumab. |
| Part II: Selicrelumab, Bevacizumab | EXPERIMENTAL | Bevacizumab will be administered via IV infusion on days 1 and 15 of every 28-day cycle. Selicrelumab will be given SC after the Bevacizumab infusion at the dose determined in the Part I of the study on Day 2 of Cycles 1 to 4 and every third cycle thereafter. Treatment will continue as long as the participant experiences clinical benefit or until unacceptable toxicity, withdrawal of consent, or the end of Part II of the study (expected 18 months). |
| Name | Type | Description |
|---|---|---|
| Emactuzumab | DRUG | Emactuzumab will be administered IV every 3 weeks (every cycle) during Part I and every 3 or 6 weeks (every cycle or every other cycle) during Part II. |
| RO7009789 | DRUG | RO7009789 will be administered IV every 3 weeks (every cycle). |
| Selicrelumab | DRUG | Selicrelumab will be provided as concentrate for solution to be administered via SC injection |
| Vanucizumab | DRUG | Vanucizumab will be provided as solution to be administered via IV infusion. |
| Bevacizumab | DRUG | Bevacizumab will be administered via IV infusion. |
Inclusion Criteria: * Eastern Cooperative Oncology Group performance status 0 or 1 * Histologically confirmed diagnosis of locally advanced, recurrent, and/or metastatic triple-negative breast cancer, ovarian cancer, gastric cancer, colorectal cancer, pancreatic cancer, melanoma, or mesothelioma * ...
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 |
RO7009789 is an investigational small molecule developed by Roche Holding AG (ticker RHHBY) for the treatment of neoplasms, or solid tumors. It has been studied in a Phase 1 clinical trial in participants with advanced solid tumors. It is not described as approved and remains an investigational agent in clinical development.
RO7009789 has been studied for use in neoplasms, specifically advanced solid tumors. It was evaluated in a Phase 1 trial in combination with emactuzumab in participants with advanced solid tumors. The program is investigational and the trial has been completed.
RO7009789 is made by Roche Holding AG, which trades under the ticker RHHBY. Roche is the developer of the asset and sponsored the Phase 1 study of RO7009789 in combination with emactuzumab in participants with advanced solid tumors.
RO7009789 is in Phase 1 development. It has been studied in a single Phase 1 clinical trial in participants with advanced solid tumors. That trial is completed, and no active trials are ongoing. RO7009789 is investigational and has not been described as approved.
RO7009789 has been studied in one clinical trial, NCT02760797, titled A Study of Emactuzumab and RO7009789 Administered in Combination in Participants With Advanced Solid Tumors. It was a Phase 1, controlled trial that enrolled 38 participants across the United States, Belgium, and France. The trial is completed.