Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 | 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 |