A Study to Evaluate CRB-701 Compared to Investigator's Choice Therapy in Previously Treated Oropharyngeal Squamous Cell Carcinoma

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Objective Response Rate (%) — Up to 24 months
  Measured using RECIST version 1.1 by Blinded Independed Central Review (BICR)
• Overall Survival (months) — Approximately 3 years from randomization
  Median time to death from any cause

Trial sites (29)