An Open-label, Phase I Clinical Study to Evaluate the Safety, Tolerability and Efficacy of IBI939 in Combination With Sintilimab in Patients With Advanced Lung Cancer

Innovent Biologics (Suzhou) Co. Ltd.1 site in 1 country19 target enrollmentJanuary 25, 2021

ConditionsAdvanced Lung Cancer

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Advanced Lung Cancer
Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Enrollment: 19
Locations: 1
Primary Endpoint: Recommended Phase II Dose(RP2D)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is an open-label, phase I clinical study to evaluate the efficacy, tolerability and safety of recombinant fully human anti-TIGIT antibody (IBI939) in combination with recombinant fully human anti-programmed cell death receptor 1 (PD-1) antibody (sintilimab) in subjects with advanced lung cancer.

Registry

clinicaltrials.gov

Start Date

January 25, 2021

End Date

June 1, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Signed the Informed Consent Form;
•Male or female ≥ 18 and≤75 years of age;
•Life expectancy ≥ 12 weeks;
•Eastern Cooperative Oncology Group Performance Status (ECOG PS) score is 0 or 1
•Have at least 1 lesion (not previously irradiated) with an accurately measured longest diameter ≥ 10 mm by computed tomography (CT) or magnetic resonance imaging (MRI) (intravenous contrast agent is preferred) at baseline (except lymph nodes which must have short axis ≥ 15 mm) according to RECIST V1.1 and lesions amenable to repeated accurate measurements.
•Histologically or cytologicallyconfirmed non-small cell lung or small cell lung cancer

Exclusion Criteria

•Previous exposure to immune-mediated therapy; previous use of antitumor vaccine;
•Received the last anti-tumor therapy within 4 weeks prior to the first dose of study drug;
•Received any investigational agent within 4 weeks prior to the first dose of study drug;
•Received systemic treatment with Chinese herbal medicine indicated for cancer or drugs used for immunoregulation (including thymosin, interferon, interleukin, except for local use for pleural effusion) within 2 weeks before the first dose;
•Are participating in another interventional clinical study, or observational (non-interventional) clinical study or in the follow-up phase of an interventional study;