NCT04672369CompletedPhase 1
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
Innovent Biologics (Suzhou) Co. Ltd.1 site in 1 country42 target enrollmentStarted: June 6, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Objective response rate(ORR)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 cytologically confirmednon-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;
Outcomes
Primary Outcomes
Objective response rate(ORR)
Time Frame: 6 months
Proportion of subjects with complete response(CR) or partial response(PR).
Secondary Outcomes
- Trough concentration (Cmin)(24 hours)
- adverse event(3 months)
- Overall Survival(OS)(6 months)
- Time to Objective Response(TTR)(6 months)
- Area under the plasma concentration-time curve (AUC)(24 hours)
- Progression-free survival(PFS)(6 months)
- Disease Control Rate(DCR)(6 months)
- Duration of Response (DoR)(6 months)
- Clearance (CL), 12. volume of distribution (V)(24 hours)
- Maximum concentration (Cmax)(24 hours)
- Half-life (t1/2)(24 hours)
Investigators
Study Sites (1)
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