Clinical Trial

Clinical Experience and Real-world Safety and Effectiveness of Envafolimab: Patient Access Program

Study acronym: ENCOMPASS STUD
Not Yet Recruiting
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Summary
Envafolimab is a novel PD-L1 inhibitor administered via subcutaneous (SC) injection - notably the first such checkpoint inhibitor approved for use worldwide.\[1\] In November 2021, Envafolimab received its first approval in China for adults with advanced microsatellite instability-high or mismatch repair-deficient (MSI-H/dMMR) solid tumors that have progressed after standard therapies. This SC route offers substantial practical advantages, significantly shortening treatment administration time and sparing patients from the adverse effects associated with intravenous infusions. Early clinical trials have demonstrated that Envafolimab can induce durable tumor responses, with objective response rates \~45% (including \~12% complete responses) observed in dMMR/MSI-H cancers. The therapy has also shown a favorable tolerability profile, with no infusion-related reactions and low rates of severe immune-mediated adverse events reported in initial studies.
Trial Details
NCT Number NCT07562347
Lead Sponsor IR INNOVATE RESEARCH PRIVATE LIMITED
Collaborators: Glenmark Pharmaceuticals Ltd. India
Conditions Advanced Solid Tumor
Enrollment 120 participants
Start Date 2026-05
Primary Completion 2027-01 (estimated)
Study Completion 2027-10 (estimated)
Updated on ClinicalTrials.gov 2026-05-01