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

Conditions

• Oropharyngeal Carcinoma (OPC)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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.

Key Dates

First listed

Aug 17, 2026

Start date

Sep 20, 2026

Status verified

Aug 2026

Primary completion

Dec 31, 2027

Completion

Mar 31, 2029

Study Design

Enrollment

260 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: CRB-701
  3.6mg/Kg CRB-701 administered intravenously Q3W.
• Active Comparator: Investigator's Choice monotherapy
  Investigator's choice of capcitabine, cetuximab or docetaxel

Primary Outcome Measure

Objective Response Rate (%) [ Time Frame: Up to 24 months ]

Locations (1)

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