CRB-701 vs investigator's choice therapy for oropharyngeal cancer after prior treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 interventional trial compares CRB-701, an antibody-drug conjugate, against investigator's choice therapy in patients with recurrent or metastatic oropharyngeal squamous cell carcinoma who have progressed after platinum-based chemotherapy and/or anti-PD-(L)1 therapy. Participants receive infusions every three weeks and undergo CT or MRI every six weeks to assess tumor response and safety, while quality of life is monitored. The trial aims to measure objective response rate by imaging and to document treatment-related adverse events. Eligible patients typically have measurable disease, good performance status, and adequate organ function. The study is conducted at several cancer centers in the United States and is sponsored by Corbus Pharmaceuticals with collaborators CSPC Megalith Biopharmaceutical.

Why it matters

Who can join: the full rules

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

Where it's running

• Florida Cancer Specialists and Research Institute
  Orlando, Florida, United States Recruiting
• Nebraska Cancer Specialists - Methodist Estabrook Cancer Center
  Omaha, Nebraska, United States Recruiting
• Gabrail Cancer Center and Research Center
  Canton, Ohio, United States Recruiting
• Clearview Cancer Institute
  Huntsville, Alabama, United States Not yet recruiting
• The University of Arizona Cancer Center
  Tucson, Arizona, United States Not yet recruiting
• City of Hope Comprehensive Cancer Center
  Duarte, California, United States Not yet recruiting

+61 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Cesar Peres, MD — Florida Cancer Specialists and Research Institute and Sarah Cannon Research Institute
• Study coordinator: Clinical Study Coordinator
• Email: clinical@corbuspharma.com
• Phone: 1+(216) 444-8950

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.