drugset / Trial / NCT03568539

IBI308 in Subjects With Advanced/Metastatic Solid Malignancies

NCT03568539

Phase 1 Completed 39 enrolled Innovent Biologics (Suzhou) Co. Ltd.
NaSingle-groupOpen-labelTreatment

Summary

The study is to evaluate preliminary anti-tumor activity (overall response rate, ORR) of IBI308 monotherapy in subjects with advanced/metastatic solid malignancies. Patients will be recruited for 2 cohorts: • Cohort 1: Advanced/metastatic cancers with TMB\>10 mutations per megabase (mut/Mb). This enrollment of this cohort has been stopped per sponsor's communication with the sites. For patients who have already enrolled in this cohort, treatment and monitoring will be conducted as stipulated by the protocol. The patients will remain on study until disease progression or intolerable toxicity, death, withdrawal of consent, or end of study, whichever occurs first. Cohort 2: Advanced/metastatic endometrial cancer (N=40)

Timeline

Start
2018-06-27
Primary completion
2020-11-09
Completion
2020-12-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Sintilimab Monoclonal antibody 200 mg Intravenous