Back to resultsA Study to Evaluate the Safety , Tolerability and Efficacy of IBI939 in Combination With Sintilimab in Patients With Advanced Lung Cancer
Primary Purpose
Advanced Lung Cancer
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
IBI939
Sintilimab
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Lung Cancer
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;
Sites / Locations
- Jilin Province Cancer Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Phase Ia: IBI939 in combination with Sintilimab
Phase Ia:IBI939 in combination with Sintilimab
Arm Description
IBI939 10mg/kg combination with Sintilimab
IBI939 20mg/kg combination with Sintilimab
Outcomes
Primary Outcome Measures
Adverse Events
Recommended Phase II Dose(RP2D)
Secondary Outcome Measures
Objective response rate(ORR)
Proportion of subjects with complete response (CR) or partial response (PR).
Disease Control Rate(DCR)
Proportion of subjects with complete response (CR), partial response (PR), or stable disease (SD).
Time to Objective Response (TTR)
Time from randomization to first objective tumor response (CR or PR).
Duration of Response (DoR)
The time from the first documented objective tumor response (CR or PR) to objective disease progression (PD) or death.
Progression-free survival(PFS)
The time from randomization to the first occurrence of objective disease progression or death
Area under the plasma concentration-time curve (AUC)
Maximum concentration (Cmax)
Trough concentration (Cmin)
Clearance (CL)
Volume of distribution (V)
Half-life (t1/2)
Full Information
NCT ID
NCT04672356
First Posted
December 13, 2020
Last Updated
June 18, 2023
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04672356
Brief Title
A Study to Evaluate the Safety , Tolerability and Efficacy of IBI939 in Combination With Sintilimab in Patients With Advanced Lung Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 25, 2021 (Actual)
Primary Completion Date
January 1, 2023 (Actual)
Study Completion Date
June 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Phase Ia: IBI939 in combination with Sintilimab
Arm Type
Experimental
Arm Description
IBI939 10mg/kg combination with Sintilimab
Arm Title
Phase Ia:IBI939 in combination with Sintilimab
Arm Type
Experimental
Arm Description
IBI939 20mg/kg combination with Sintilimab
Intervention Type
Biological
Intervention Name(s)
IBI939
Intervention Description
IBI939 injection
Intervention Type
Biological
Intervention Name(s)
Sintilimab
Intervention Description
Sintilimab injection
Primary Outcome Measure Information:
Title
Adverse Events
Time Frame
3 months
Title
Recommended Phase II Dose(RP2D)
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Objective response rate(ORR)
Description
Proportion of subjects with complete response (CR) or partial response (PR).
Time Frame
6 months
Title
Disease Control Rate(DCR)
Description
Proportion of subjects with complete response (CR), partial response (PR), or stable disease (SD).
Time Frame
6 months
Title
Time to Objective Response (TTR)
Description
Time from randomization to first objective tumor response (CR or PR).
Time Frame
6 months
Title
Duration of Response (DoR)
Description
The time from the first documented objective tumor response (CR or PR) to objective disease progression (PD) or death.
Time Frame
6 months
Title
Progression-free survival(PFS)
Description
The time from randomization to the first occurrence of objective disease progression or death
Time Frame
6 months
Title
Area under the plasma concentration-time curve (AUC)
Time Frame
24 hours
Title
Maximum concentration (Cmax)
Time Frame
24 hours
Title
Trough concentration (Cmin)
Time Frame
24 hours
Title
Clearance (CL)
Time Frame
24 hours
Title
Volume of distribution (V)
Time Frame
24 hours
Title
Half-life (t1/2)
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ying Cheng
Organizational Affiliation
Jilin Province Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jilin Province Cancer Hospital
City
Jilin
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Safety , Tolerability and Efficacy of IBI939 in Combination With Sintilimab in Patients With Advanced Lung Cancer
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