At a glance
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NCT06612632Phase 2RecruitingMonitorUpdated 21mo ago · Completion was 1mo agoA Umbrella Study to Evaluate the Safety and Preliminary Efficacy of Combined or Sequential Immunotherapy in Patients with Advanced Solid Tumors Progressing on Clinical Trial Drugs
In Brief
A Phase 2 clinical trial evaluating research drug in combination with Toripalimab and Toripalimab for Cancer. Currently recruiting, targeting 100 participants across 1 site.
Signals
Detailed Summary
This study plans to include approximately 60-100 patients with advanced solid tumors who have progressed on clinical trial drugs. It will use an open-label, single-arm, multi-cohort umbrella design. In the first phase, patients who have progressed during treatment with novel tumor immunotherapy drugs will initially be targeted, combining or sequencing with PD-1 monoclonal antibody therapy. The inclusion criteria for frontline clinical trials are as follows: priority will be given to phase I clinical trials of novel immunotherapeutics as monotherapy, such as tumor vaccines, NK cell therapy, and new immune checkpoint inhibitors. Based on preliminary data, these have shown synergistic effects with PD-1/L1 monoclonal antibodies. In principle, the same investigational drug will only be used in either a combination or sequencing cohort. Subsequently, the study will expand to include patients who have progressed on other clinical trial treatments, combining or sequencing with other immune mechanism drugs.
Study Details
Timeline
Interventions
research drug in combination with Toripalimab
Toripalimab