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
• Interventions: Biological: IBI939; Biological: Sintilimab

• 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

Arm && Interventions

Group	Intervention	Description
Phase Ia: IBI939 in combination with Sintilimab	Sintilimab	IBI939 10mg/kg combination with Sintilimab
Phase Ia: IBI939 in combination with Sintilimab	IBI939	IBI939 10mg/kg combination with Sintilimab
Phase Ia:IBI939 in combination with Sintilimab	IBI939	IBI939 20mg/kg combination with Sintilimab
Phase Ia:IBI939 in combination with Sintilimab	Sintilimab	IBI939 20mg/kg combination with Sintilimab

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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).
Half-life (t1/2)	24 hours
Time to Objective Response (TTR)	6 months	Time from randomization to first objective tumor response (CR or PR).
Clearance (CL)	24 hours
Volume of distribution (V)	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