NCT03568539

IBI308 in Subjects With Advanced/Metastatic Solid Malignancies

An Open-label, Phase 1b Multicenter Study of IBI308 in Subjects With Advanced/Metastatic Solid Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Advanced/Metastatic Solid Malignancies

Interventions

Type	Name	Description
DRUG	IBI308	IBI308 200mg IV infusion, every 3 weeks.

Timeline

• Start date: 2018-06-27
• Primary completion: 2020-11-09
• Completion: 2020-12-07
• First posted: 2018-06-26
• Last updated: 2021-06-01
• Results posted: 2021-06-01

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study