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

CIBI939A102(Ia)

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.

2021-01-25

2023-01-01

2023-06-01

Completed

Early phase I

19

Inclusion Criteria: 1. Signed the Informed Consent Form; 2. Male or female ≥ 18 and≤75 years of age; 3. Life expectancy ≥ 12 weeks; 4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score is 0 or 1 5. 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. 6. Histologically or cytologicallyconfirmed non-small cell lung or small cell lung cancer Exclusion Criteria: 1. Previous exposure to immune-mediated therapy; previous use of antitumor vaccine; 2. Received the last anti-tumor therapy within 4 weeks prior to the first dose of study drug; 3. Received any investigational agent within 4 weeks prior to the first dose of study drug; 4. 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; 5. Are participating in another interventional clinical study, or observational (non-interventional) clinical study or in the follow-up phase of an interventional study;

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 19, 'type': 'ACTUAL'}}

2023-06-22