Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CRB-701 · 2 trials · 2 indications
Measured using RECIST version 1.1 by Blinded Independed Central Review (BICR)
Median time to death from any cause
Occurrence of Dose Limiting Toxicities as defined in the protocol
ORR is the percentage of participants that achieve a response (CR + PR) using RECIST 1.1
| Arm | Type | Description |
|---|---|---|
| CRB-701 | EXPERIMENTAL | 3.6mg/Kg CRB-701 administered intravenously Q3W. |
| Investigator's Choice monotherapy | ACTIVE_COMPARATOR | Investigator's choice of capecitabine, cetuximab or docetaxel |
| Part A Dose Escalation - CRB-701 Dose Level 1 | EXPERIMENTAL | CRB-701 Dose level 1, intravenous infusion over 30 mins, Dose schedule 1 |
| Part A Dose Escalation - CRB-701 Dose Level 2 | EXPERIMENTAL | CRB-701 Dose Level 2, intravenous infusion over 30 mins, Dose schedule 1 |
| Part A Dose Escalation - CRB-701 Dose Level 3 | EXPERIMENTAL | CRB-701 Dose Level 3, intravenous infusion over 30 mins, dose schedule 1 |
| Part A Dose Escalation - CRB-701 Dose Level 4 | EXPERIMENTAL | CRB-701 Dose Level 4, intravenous infusion over 30 mins, dose schedule 1 |
| Part B Dose Optimization: CRB-701 High dose | EXPERIMENTAL | Selected high dose of CRB-701, intravenous infusion over 30 mins, dose schedule 1 |
| Part B Dose Optimization: CRB-701 low dose | EXPERIMENTAL | Selected Low dose of CRB-701, intravenous infusion over 30 mins |
| Part C Dose Expansion - Cohort 1 | EXPERIMENTAL | Recommended CRB-701 dose and schedule, intravenous infusion over 30 mins followed by infusion with anti-PD-1 |
| Part C Dose Expansion - Cohort 2 | EXPERIMENTAL | Recommended CRB-701 dose and schedule, intravenous infusion over 30 mins |
| Part C Dose Expansion - Cohort 3 | EXPERIMENTAL | Recommended CRB-701 dose and schedule, intravenous infusion over 30 mins followed by infusion with anti-PD-1 |
| Part C Dose Expansion - Cohort 4 | EXPERIMENTAL | Recommended CRB-701 dose and schedule, intravenous infusion over 30 mins |
| Part C Dose Expansion - Cohort 5 | EXPERIMENTAL | Recommended CRB-701 dose and schedule, intravenous infusion over 30 mins followed by infusion with anti-PD-1 |
| Part B Dose Optimization: CRB-701 high dose combined with anti-PD-1 | EXPERIMENTAL | Selected high dose of CRB-701, intravenous infusion over 30 mins followed by infusion with anti-PD-1 |
| Part B Dose Optimization: CRB-701 low dose combined with anti-PD-1 | EXPERIMENTAL | Selected low dose of CRB-701, intravenous infusion over 30 mins followed by infusion with anti-PD-1 |
| Part C Dose Expansion - Cohort 6 | EXPERIMENTAL | Recommended CRB-701 dose and schedule, intravenous infusion over 30 mins |
| Part C Dose Expansion - Cohort 7 | EXPERIMENTAL | Recommended CRB-701 dose and schedule, intravenous infusion over 30 mins followed by infusion with anti-PD-1 |
| Name | Type | Description |
|---|---|---|
| CRB-701 | DRUG | CRB-701 3.6mg/Kg administered intravenously every 21 days (Q3W) |
| capcitabine | DRUG | 1250 mg/m2 twice daily on days 1-14 of each 21-day cycle |
| Cetuximab (EGFR inhibitor) | DRUG | 400mg/m2 loading dose followed by 250mg/m2 weekly as an IV infusion or 500mg/m2 every 2 weeks. |
| Docetaxel | DRUG | 75 mg/m2 as an IV infusion on day 1 of each 21-day cycle or 30 mg/m2 weekly to escalate to 40 mg/m2, if tolerated. |
| Anti-PD-1 | DRUG | checkpoint inhibitor |
Inclusion Criteria: * Histological and/or cytological confirmed diagnosis of OPSCC arising from tonsils, base of tongue, soft palate and posterior pharyngeal wall, with evidence of metastatic or recurrent disease not amenable to standard therapy with curative intent. * Either second or third-line O...
CRB-701 is an investigational small molecule being studied for the treatment of oropharyngeal carcinoma (OPC) and solid tumors in adults. It is currently in clinical development, with a Phase 3 trial planned for previously treated oropharyngeal squamous cell carcinoma and a Phase 1/2 trial for solid tumors.
CRB-701 targets Nectin-4, a protein involved in cell adhesion that is overexpressed in certain tumors. By targeting Nectin-4, the drug aims to deliver therapeutic effects specifically to cancer cells. This mechanism is being evaluated in clinical trials for oropharyngeal carcinoma and solid tumors.
CRB-701 is being developed by Corbus Pharmaceuticals Holdings, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol CRBP. The company is conducting clinical trials to evaluate the drug's safety and efficacy in oncology indications.
CRB-701 is in Phase 3 clinical development for oropharyngeal carcinoma, with a randomized, active-controlled trial planned. It is also being studied in a Phase 1/2 trial for solid tumors. The drug has received Fast Track designation from the FDA, but it is not yet approved and remains investigational.
CRB-701 is being evaluated in two clinical trials. NCT06265727 is a Phase 1/2 study in solid tumors, currently recruiting in the US and Europe. NCT07768189 is a Phase 3 study comparing CRB-701 to investigator's choice therapy in previously treated oropharyngeal squamous cell carcinoma, not yet recruiting.
No alternative names for CRB-701 have been disclosed. It is a distinct investigational compound developed by Corbus Pharmaceuticals. Readers searching for this drug should use the name CRB-701, as no other designations have been reported.