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

Phase 1

Completed

• Conditions: Advanced Lung Cancer

• Registration Number: NCT04672356
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-13
• Study First Submitted QC: 2020-12-16
• Study First Posted: 2020-12-17
• Study Start: 2021-01-25
• Primary Completion: 2023-01-01
• Status Verified: 2023-06
• Study Completion: 2023-06-01
• Last Update Submitted: 2023-06-18
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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 cytologicallyconfirmed non-small cell lung or 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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Recommended Phase II Dose(RP2D)	2 months
Adverse Events	3 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Jilin Province Cancer Hospital; 🇨🇳 Jilin, China