Clinical trial NCT04672369: A Study to Evaluate the Efficacy of IBI939 in Combination With Sintilimab in Patients With Advanced NSCLC
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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Lung Cancer
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2020-12-17
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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;

Primary outcomes:
measure: Objective response rate(ORR)
timeFrame: 6 months
Secondary outcomes:
measure: adverse event
timeFrame: 3 months
measure: Progression-free survival(PFS)
timeFrame: 6 months
measure: Overall Survival(OS)
timeFrame: 6 months
measure: Disease Control Rate(DCR)
timeFrame: 6 months
measure: Duration of Response (DoR)
timeFrame: 6 months
measure: Time to Objective Response(TTR)
timeFrame: 6 months
measure: Area under the plasma concentration-time curve (AUC)
timeFrame: 24 hours
measure: Maximum concentration (Cmax)
timeFrame: 24 hours
measure: Trough concentration (Cmin)
timeFrame: 24 hours
measure: Clearance (CL), 12. volume of distribution (V)
timeFrame: 24 hours
measure: Half-life (t1/2)
timeFrame: 24 hours
Other outcomes:
Locations:
city: Jilin
country: China
facility: Jilin Province Cancer Hospital
Study officials:
affiliation: Jilin Province Cancer Hospital
name: Ying Cheng
role: PRINCIPAL_INVESTIGATOR
References: