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 cancer therapy being studied in adults with oropharyngeal carcinoma (OPC) and in adults with solid tumors. It is being developed by Corbus Pharmaceuticals Holdings, Inc. (ticker CRBP). The lead program targets previously treated oropharyngeal squamous cell carcinoma, a type of head and neck cancer.
CRB-701 targets Nectin-4, a protein expressed on the surface of certain tumor cells. Nectin-4 is a member of the nectin family of cell adhesion molecules and is a recognized target class in oncology drug development. CRB-701 is a small molecule directed at this protein target.
CRB-701 is being developed by Corbus Pharmaceuticals Holdings, Inc., which trades under the ticker CRBP. Corbus is the sponsor of the clinical program evaluating CRB-701 in oropharyngeal carcinoma and in adult solid tumors.
CRB-701 is in Phase 3 clinical development. The Phase 3 trial is recruiting, and an earlier Phase 1/2 study in adult solid tumors is also recruiting. CRB-701 has received Fast Track designation from the FDA. It remains investigational and is not approved for commercial use.
CRB-701 is being studied in two recruiting trials. NCT07768189 is a Phase 3 study comparing CRB-701 to investigator's choice therapy in previously treated oropharyngeal squamous cell carcinoma, enrolling 260 patients across the United States, Europe, South Korea and Taiwan. NCT06265727 is a Phase 1/2 study in adult solid tumors.
Yes. The Phase 3 trial of CRB-701, NCT07768189, is a randomized, active-controlled study comparing CRB-701 against investigator's choice therapy in previously treated oropharyngeal squamous cell carcinoma. It is not double-blinded. The trial is recruiting adults aged 18 years and older, with enrollment planned at 260 participants.