Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Selicrelumab · 1 trial · 1 indication
From Day (D) 1 until D28 of Cycle (C)1 (cycle length=28 days)
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: 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 |
|---|---|---|
| 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: * Part I: Histologically confirmed advanced/metastatic solid tumor (except prostate cancer and squamous non-small cell lung cancer \[NSCLC\]) * Part II: Histologically confirmed advanced/metastatic platinum-resistant ovarian carcinoma (aPROC), head and neck squamous cell carcino...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
Selicrelumab is an investigational small molecule being studied for the treatment of advanced or metastatic solid tumors. It is in Phase 1 clinical development and has not been approved by regulatory authorities. Its use is limited to clinical research settings.
Selicrelumab is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical trials to evaluate the drug's safety and activity in patients with advanced or metastatic solid tumors.
Selicrelumab is in Phase 1 clinical development. It is an investigational drug and has not been approved for any use. One Phase 1 trial has been completed, and the drug remains under evaluation for safety and therapeutic activity.
Selicrelumab has been studied in one completed Phase 1 trial, NCT02665416. This trial evaluated the safety, pharmacokinetics, pharmacodynamics, and therapeutic activity of Selicrelumab in combination with vanucizumab or bevacizumab in participants with metastatic solid tumors.
Yes, Selicrelumab is also known as RO7009789. The completed clinical trial NCT02665416 used the name RO7009789 to refer to the drug, confirming that both names designate the same investigational compound.