Advanced Lung Cancer Clinical Trial
Official title:
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
Verified date | June 2023 |
Source | Innovent Biologics (Suzhou) Co. Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 42 |
Est. completion date | June 1, 2023 |
Est. primary completion date | January 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 cytologically confirmednon-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; |
Country | Name | City | State |
---|---|---|---|
China | Jilin Province Cancer Hospital | Jilin |
Lead Sponsor | Collaborator |
---|---|
Innovent Biologics (Suzhou) Co. Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective response rate(ORR) | Proportion of subjects with complete response(CR) or partial response(PR). | 6 months | |
Secondary | adverse event | 3 months | ||
Secondary | Progression-free survival(PFS) | The time from randomization to the first occurrence of objective disease progression or death | 6 months | |
Secondary | Overall Survival(OS) | The time from randomization to death due to any cause. | 6 months | |
Secondary | Disease Control Rate(DCR) | Proportion of subjects with complete response (CR), partial response (PR), or stable disease (SD). | 6 months | |
Secondary | Duration of Response (DoR) | The time from the first documented objective tumor response(CR or PR) to objective disease progression (PD) or death. | 6 months | |
Secondary | Time to Objective Response(TTR) | Time from randomization to first objective tumor response (CR or PR). | 6 months | |
Secondary | Area under the plasma concentration-time curve (AUC) | 24 hours | ||
Secondary | Maximum concentration (Cmax) | 24 hours | ||
Secondary | Trough concentration (Cmin) | 24 hours | ||
Secondary | Clearance (CL), 12. volume of distribution (V) | 24 hours | ||
Secondary | Half-life (t1/2) | 24 hours |
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