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.
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.
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.
Parallel
CRB-701
DrugCRB-701 3.6mg/Kg administered intravenously every 21 days (Q3W)
capcitabine
Drug1250 mg/m2 twice daily on days 1-14 of each 21-day cycle
Cetuximab (EGFR inhibitor)
Drug400mg/m2 loading dose followed by 250mg/m2 weekly as an IV infusion or 500mg/m2 every 2 weeks.
Docetaxel
Drug75 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.
Objective Response Rate (%)
Measured using RECIST version 1.1 by Blinded Independed Central Review (BICR)
Overall Survival (months)
Median time to death from any cause
Progression Free Survival (Months)
Median time to radiographic progression per RECIST 1.1 as assessed by BICR
Duration of Response (Months)
Duration of response to intervention as measured by RECIST 1.1 and assessed by BICR
Change in baseline in EORTC QLQ-C30 functional and symptom scales
Change from baseline in functional and symptom scales on the EORTC QLQ-C30 questionnaire. All individual functions and symptoms are measured on a scale ranging 1-4. In the functional scales a higher score represents better functioning and health. With the symptom scales a higher score represents a more severe symptom and poor health. A total score of 0-100 is derrived from the raw scores with a higher score indicating better health
Objective Response Rate (%)
Proportion of participants that respond to treatment by RECIST 1.1 assessed by Investigator
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Corbus Pharmaceuticals Inc.
Lead sponsor
CSPC Megalith Biopharmaceutical Co.,Ltd.
Collaborator
