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

Study acronym: TEMPO-1
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment opened Trial sites expanded: 29 → 111 locations · Start date changed from estimate of Sep 20, 2026 to Sep 29, 2026 · Eligibility criteria expanded, about 10 words · 1 more Show 4 more changesShow less
    • Trial sites expanded: 29 → 111 locations
    • Start date changed from estimate of Sep 20, 2026 to Sep 29, 2026
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 2 of 10 entries
  2. Study sites: 28 to 29v4
  3. Study sites: 27 to 28v3
  4. Trial sites expanded: 1 → 27 locations Study title shortened, about 2 wordsv2 Show 1 more changeShow less
    • Study title shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07768189
Lead Sponsor Corbus Pharmaceuticals Inc.
Collaborators: CSPC Megalith Biopharmaceutical Co.,Ltd.
Conditions Oropharyngeal Carcinoma (OPC)
Enrollment 260 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov