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NOT YET RECRUITING
NCT07562347

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

Sponsor: IR INNOVATE RESEARCH PRIVATE LIMITED

View on ClinicalTrials.gov

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.

Official title: Clinical Experience and Real-world Safety and Effectiveness of Envafolimab: Observational, Non-interventional Outcomes From a Multi-country Named Patient Access Program (ENCOMPASS STUDY)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

120

Start Date

2026-05

Completion Date

2027-10

Last Updated

2026-05-01

Healthy Volunteers

No

Interventions

DRUG

Envafolimab

In this study, there is no active intervention because it is an observational, non-interventional study.