A Study to Evaluate the Safety , Tolerability and Efficacy of IBI939 in Combination With Sintilimab in Patients With Advanced Lung Cancer

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Advanced Lung Cancer

Intervention / Treatment
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* Biological: IBI939
* Biological: Sintilimab


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phase Ia: IBI939 in combination with Sintilimab<br>IBI939 10mg/kg combination with Sintilimab | Biological: IBI939<br>* IBI939 injection<br>Biological: Sintilimab<br>* Sintilimab injection<br>|
| Experimental: Phase Ia:IBI939 in combination with Sintilimab<br>IBI939 20mg/kg combination with Sintilimab | Biological: IBI939<br>* IBI939 injection<br>Biological: Sintilimab<br>* Sintilimab injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events |  | 3 months | 
| Recommended Phase II Dose(RP2D) |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate(ORR) | Proportion of subjects with complete response (CR) or partial response (PR). | 6 months | 
| Disease Control Rate(DCR) | Proportion of subjects with complete response (CR), partial response (PR), or stable disease (SD). | 6 months | 
| Time to Objective Response (TTR) | Time from randomization to first objective tumor response (CR or PR). | 6 months | 
| 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 | 
| Progression-free survival(PFS) | The time from randomization to the first occurrence of objective disease progression or death | 6 months | 
| Area under the plasma concentration-time curve (AUC) |  | 24 hours | 
| Maximum concentration (Cmax) |  | 24 hours | 
| Trough concentration (Cmin) |  | 24 hours | 
| Clearance (CL) |  | 24 hours | 
| Volume of distribution (V) |  | 24 hours | 
| Half-life (t1/2) |  | 24 hours |