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Also known as CRB-601 monoclonal antibody
CRB-601 · 1 trial · 1 indication
Incidence of treatment emergent adverse events and clinically significant changes in laboratory parameters, ECG, vital signs and physical exam findings over treatment duration
Disease Control Rate (Complete Responses plus Partial Responses plus Stable Disease for at least 4 months as determined by the Investigator using RECIST 1.1.
| Arm | Type | Description |
|---|---|---|
| Part A: Dose 1 CRB-601 monotherapy | EXPERIMENTAL | Dose 1 of CRB-601 (3mg/Kg) administered intravenously every two weeks |
| Part A: Dose 2 of CRB-601 monotherapy | EXPERIMENTAL | Dose 2 of CRB-601 (10mg/Kg) administered intravenously every two weeks |
| Part A: Dose 3 of CRB-601 monotherapy | EXPERIMENTAL | Dose 3 of CRB-601 (30mg/Kg) administered intravenously every two weeks |
| Part B/Cohort 1: Dose level (low) CRB-601 in combination with anti-PD(L)-1 | EXPERIMENTAL | Dose (defined in Part A) of CRB-601 administered intravenously in combination with anti-PD(L)-1 therapy dosed as per label. |
| Part B/Cohort 2: Dose level (high) CRB-601 in combination with anti-PD(L)-1 | EXPERIMENTAL | High dose CRB-601 (defined in Part A) of CRB-601 administered intravenously in combination with anti-PD(L)-1 therapy dosed per label. |
| Part B/Expansion: Dose level (defined in Part B/ Safety Le) CRB-601 in combination with anti-PD(L)-1 | EXPERIMENTAL | Dose (defined in Part B/ Safety Lead-In) or CRB-601 administered intravenously in combination with anti-PD(L)-1 therapy dosed per label. |
| Part C - Low dose CRB-601 in combination with anti-PD(L)-1 | EXPERIMENTAL | Participants will receive a low dose of CRB-601 (defined in Part A \&B) in combination with standard of care dose of anti-PD(L)-1 therapy. |
| Part C - High dose CRB-601 in combination with anti-PD(L)-1 | EXPERIMENTAL | Participants will receive a high dose of CRB-601 (defined in Part A \&B) in combination with standard of care dose of anti-PD(L)-1 therapy. |
| Name | Type | Description |
|---|---|---|
| CRB-601 monoclonal antibody | DRUG | CRB-601 |
| Anti-PD-1 monoclonal antibody | DRUG | Anti-PD(L)-1 used as per label |
Inclusion Criteria: * Confirmed diagnosis of select locally advanced or metastatic solid tumors that have progressed after at least one line of therapy or have no other standard therapy with proven clinical benefit available. * Measurable disease on imaging as assessed by RECIST 1.1 Eastern Coopera...
| 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 |
CRB-601 is an investigational monoclonal antibody being developed by Corbus Pharmaceuticals Holdings, Inc. for the treatment of advanced solid tumors. It is in Phase 1 clinical development and is designed to act on αvβ8 integrin. CRB-601 is also known as the CRB-601 monoclonal antibody.
CRB-601 is being studied for the treatment of advanced solid tumors in adults. Its only registered clinical trial, NCT06603844, is a first-in-human study enrolling patients with advanced solid tumor. The drug is investigational and has not been approved for any use.
CRB-601 targets αvβ8 integrin, a member of the integrin family of cell surface receptors. CRB-601 is a monoclonal antibody designed to bind this integrin target. The Phase 1 study NCT06603844 is evaluating the antibody in patients with advanced solid tumors.
CRB-601 is being developed by Corbus Pharmaceuticals Holdings, Inc., which trades under the ticker CRBP. The company is running the first-in-human Phase 1 study of the monoclonal antibody in advanced solid tumors in the United States and the United Kingdom.
CRB-601 is in Phase 1 clinical development. It is investigational and is not approved by the FDA for any indication. Its single registered trial, NCT06603844, is a first-in-human Phase 1 study that is currently recruiting participants.
CRB-601 is being evaluated in one clinical trial, NCT06603844, titled First-in-human Study of CRB-601-01 to Treat Patients With Advanced Solid Tumor. The Phase 1 trial is recruiting an estimated 156 participants aged 18 years and older across the United States and the United Kingdom.