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Immunotherapy Rechallenge in Patients with Solid Tumors in Clinical Trials
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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.
Official title: A 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2024-05-24
Completion Date
2028-06
Last Updated
2024-09-25
Healthy Volunteers
No
Conditions
Interventions
research drug in combination with Toripalimab
research drug in combination with Toripalimab
Toripalimab
Toripalimab
Locations (1)
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China