Recruiting
Phase 3

CRB-701

Sponsor:

Corbus Pharmaceuticals Inc.

Code:

NCT07768189

Conditions

Oropharyngeal Carcinoma (OPC)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CRB-701

capcitabine

Cetuximab (EGFR inhibitor)

Docetaxel

Study Details

Brief summary:

The goal of this study is to understand whether CRB-701, a targeted form of chemotherapy called an anti-body drug conjugate, will work as a treatment for oropharyngeal (throat, tonsil) cancer. In patients who have already received platinum based chemotherapy or immunotherapy (using a check-point inhibitor) It will also learn about the safety of the drug and measure quality of life. The main questions it asks are:

  • What proportion of participants respond to CRB-701 measured using scans (CT or MRI)
  • What medical problems do participants experience when taking CRB-701.

Researchers will compare CRB-701 with standard of care medicines (drugs that are normally used this disease).

Participants will:

  • Attend clinic every three weeks to receive infusions of CRB-701 or standard of care medicines until the cancer cannot be measured or is not controlled by the treatment they are receiving.
  • Have a CT or MRI every 6 weeks to measure the effect on their cancer
  • Complete questionnaires to assess their health status.

Conditions

Oropharyngeal Carcinoma (OPC)

Study ID

NCT07768189

Start date

Sep 29, 2026

Status verified date

Oct, 2026

Completion date

Mar, 2029

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 OPSCC patients who have progressed on or after receiving SOC therapy (that must have included platinum chemotherapy and an anti-PD-(L)1 antibody administered sequentially or together) OR received platinum chemotherapy and/or anti-PD-(L)1 therapy in the neoadjuvant or adjuvant setting or as part of definitive chemoradiation therapy, provided disease recurrence occurred less than 6 months after completion of the relevant systemic therapy.
  • ECOG PS of 0-1
  • Measurable disease as per RECIST v1.1, with at least one measurable lesion not previously irradiated unless unequivocal progression has been documented after radiation.
  • Life expectancy of greater than 12 weeks at time of enrollment, as per Investigator's assessment.

Signed informed consent

Exclusion Criteria:

  • Persistent CTCAE Grade >1 clinically significant toxicities related to prior antineoplastic therapies, excluding alopecia.
  • Significant active or chronic corneal disorders
  • Pre-existing Grade ≥2 peripheral neuropathy
  • Any other significant co-morbidities, disease, metabolic dysfunction, physical examination, or clinical laboratory finding that contraindicates the use of the investigational drug or may represent an unacceptable risk from treatment complications or may affect adherence to the study procedures or the interpretation of the results.
  • Pregnant or breastfeeding females

Study Design

Enrollment

260 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CRB-701

3.6mg/Kg CRB-701 administered intravenously Q3W.

active comparator: Investigator's Choice monotherapy

Investigator's choice of capecitabine, cetuximab or docetaxel

Interventions

CRB-701

CRB-701 3.6mg/Kg administered intravenously every 21 days (Q3W)

capcitabine

1250 mg/m2 twice daily on days 1-14 of each 21-day cycle

Cetuximab (EGFR inhibitor)

400mg/m2 loading dose followed by 250mg/m2 weekly as an IV infusion or 500mg/m2 every 2 weeks.

Docetaxel

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.

Primary outcome measure

  • Objective Response Rate (%) [ Time Frame: Up to 24 months ]
  • Overall Survival (months) [ Time Frame: Approximately 3 years from randomization ]

Central Contacts and Locations

Central contacts

Clinical Study Coordinator

1+(216) 444-8950clinical@corbuspharma.com

Locations

Florida Cancer Specialists and Research Institute

Recruiting

Orlando, Florida, United States, 32827

Contacts

Clinical Study Coordinator

+1 (407) 735-5695clinical@corbuspharma.com

Principal Investigator:

Cesar Perez, MD

Nebraska Cancer Specialists - Methodist Estabrook Cancer Center

Recruiting

Omaha, Nebraska, United States, 68130

Contacts

Clinical Study Coordinator

+1-(402)-717-4770clinical@corbuspharma.com

Principal Investigator:

Yungpo Su, MD

Gabrail Cancer Center and Research Center

Recruiting

Canton, Ohio, United States, 44718

Contacts

Clinical Study Coordinator

+1-(330)-492-3345clinical@corbuspharma.com

Principal Investigator:

Nashat Gabrail, MD

More Information

Sponsor

Corbus Pharmaceuticals Inc.

Last update posted

Oct 8, 2026

Last verified

Oct, 2026

Keywords

  • Antibody Drug Conjugate
  • Nectin-4
  • Oropharyngeal Squamous Cell Carcinoma
  • HPV-ve
  • HPV+ve
  • Head and Neck Squamous Cell Carcinoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by Corbus Pharmaceuticals Inc. on 2026-10-08. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.