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Safety and Preliminary Activity of BI115 in Advanced SCLC
Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Summary
This study is a multi-regional, open-label phase I study to evaluate the Safety, Tolerability, and Efficacy of IBI115 as Monotherapy and in Combination Therapy in Participants with Advanced Small Cell Lung Cancer
Official title: Phase I Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of IBI115 as Monotherapy and in Combination Therapy in Participants With Advanced Small Cell Lung Cancer
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2026-05-21
Completion Date
2030-03-30
Last Updated
2026-06-04
Healthy Volunteers
No
Conditions
Interventions
IBI115
IBI115 will be administered. The Dose Limiting Toxicity (DLT) observation period will last for 28 or 21 days after first dose. After completion of the DLT observation period, subject will continue to receive IBI115 until death, disease progression, intolerable toxicity, start of a new anticancer treatment, withdrawal od consent for study participation, end of the study, or for a maximum of 24 months, whichever occurs first.
Locations (1)
the second affiliated hospital of AMU
Chongqing, Chongqing Municipality, China