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First-in-human Study of CRB-601-01 to Treat Patients With Advanced Solid Tumor.

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary endpoints revised (3) Interventions: Anti-PD-1 monoclonal antibody (Drug), CRB-601 monoclonal antibody (Drug), Immune-priming single lesion SBRT (Radiation) to Anti-PD-1 monoclonal antibody (Drug), CRB-601 monoclonal antibody (Drug) · Secondary endpoints revised (3) · Study description shortened, about 57 words · 1 morev3 Show 4 more changesShow less
    • Interventions: Anti-PD-1 monoclonal antibody (Drug), CRB-601 monoclonal antibody (Drug), Immune-priming single lesion SBRT (Radiation) to Anti-PD-1 monoclonal antibody (Drug), CRB-601 monoclonal antibody (Drug)
    • Secondary endpoints revised (3)
    • Study description shortened, about 57 words
    • Study arms: 9 to 8

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Nov 2026 to Nov 1, 2026 · Completion date: Dec 2026 to Dec 1, 2026 · Start date changed from estimate of Oct 2024 to Dec 4, 2024 · 1 morev2 Show 4 more changesShow less
    • Primary completion date: Nov 2026 to Nov 1, 2026
    • Completion date: Dec 2026 to Dec 1, 2026
    • Start date changed from estimate of Oct 2024 to Dec 4, 2024
    • Site details revised at 26 of 26 sites
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 purpose of this study is to determine the safety, blood concentrations and treatment effect of CRB-601 in combination with immunotherapy in patients who have advanced solid tumors (cancer) and have exhausted other therapeutic options.CRB-601 targets a protein called avb8 integrin which is expressed by some cancers and not others. This study will focus on tumor types which are know to highly or moderately express this protein. Researchers will evaluate the side effects caused by treatment, levels of CRB-601 in the blood, and the effect on the participant cancer. This will help researchers understand the right dose of CRB-601 to use for treatment and whether it is an effective treatment to combine with standard of care treatments such as immunotherapy. It will also help the researchers understand whether combining CRB-601 with standard-of-care immunotherapy and immune-priming radiotherapy is a safe and effective approach to treat cancer. Participants in the study will receive CRB-601 via an infusion every two weeks either alone or in combination with immunotherapy. There will be assessments to check on the participants general health status (including blood tests) and adverse effects. Participants will also receive regular CT or MRI scans to evaluate the effect of CRB-601 on their cancer. Participants will continue to visit the clinic every two weeks while they are receiving benefit from treatment. If their cancer progresses, participants will be asked to continue to be followed-up by the researchers to understand long-term outcomes, even if they receive other treatments.
Trial Details
NCT Number NCT06603844
Lead Sponsor Corbus Pharmaceuticals Inc.
Conditions Solid Tumor
Enrollment 156 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov