Status:
COMPLETED
A Study to Evaluate the Safety , Tolerability and Efficacy of IBI939 in Combination With Sintilimab in Patients With Advanced Lung Cancer
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Conditions:
Advanced Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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 huma...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
January 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2023
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04672356
Start Date
January 25 2021
End Date
June 1 2023
Last Update
June 22 2023
Active Locations (1)
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1
Jilin Province Cancer Hospital
Jilin, China