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

NCT07768189 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2026-08-20

No results posted yet for this 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.

Conditions

  • Oropharyngeal Carcinoma (OPC)

Interventions

DRUG

CRB-701

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

DRUG

capcitabine

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

DRUG

Cetuximab (EGFR inhibitor)

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

DRUG

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.

Sponsors & Collaborators

  • CSPC Megalith Biopharmaceutical Co.,Ltd.

    collaborator INDUSTRY

  • Corbus Pharmaceuticals Inc.

    lead INDUSTRY

Principal Investigators

  • Ari Rosenberg, MD · University of Chicago

  • Cesar Peres, MD · Florida Cancer Specialists and Research Institute and Sarah Cannon Research Institute

  • Pablo Nenclares, MD · Barts & The London NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-20
Primary Completion
2027-12-31
Completion
2029-03-31
FDA Drug
Yes

Countries

  • United States
  • Austria
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07768189 on ClinicalTrials.gov