Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as RO7009789
Selicrelumab · 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 * ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
Selicrelumab is an investigational monoclonal antibody being studied for the treatment of advanced and metastatic solid tumors. It is not yet approved for any indication and remains in clinical development. Its only recorded trial enrolled 94 adults with advanced or metastatic solid tumors across the United States, Belgium, Canada, Denmark, Italy, the Netherlands, and Spain.
Selicrelumab targets CD40, a receptor on antigen-presenting cells, and acts as a CD40 agonist. By activating CD40 signaling, the antibody is designed to stimulate immune responses against tumor cells. This mechanism places selicrelumab in the immunotherapy class of oncology treatments.
Selicrelumab is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche conducted the clinical program for the drug, including its Phase 1 study in advanced and metastatic solid tumors.
Selicrelumab is in Phase 1 development. It has completed one Phase 1 clinical trial and is not FDA approved. The drug remains investigational, and no later-phase trials are currently active.
Selicrelumab has been evaluated in one completed Phase 1 trial, NCT02665416. The study assessed the safety, pharmacokinetics, pharmacodynamics, and therapeutic activity of selicrelumab (RO7009789) given with vanucizumab or bevacizumab in 94 participants with metastatic solid tumors. No trials are currently active.
Yes, selicrelumab is also known as RO7009789. RO7009789 is Roche's internal compound designation for the same CD40 agonist monoclonal antibody. Both names refer to the identical investigational drug studied in the Phase 1 trial NCT02665416.