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

Advanced Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04672356
• Other study ID #: CIBI939A102(Ia)
• Status: Completed
• Phase: Phase 1
• Start date: January 25, 2021
• Est. completion date: June 1, 2023

Study information

• Verified date: June 2023
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: June 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Advanced Lung Cancer
• Lung Neoplasms

Intervention

Biological:
• IBI939
IBI939 injection
• Sintilimab
Sintilimab injection

Locations

Country	Name	City	State
China	Jilin Province Cancer Hospital	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events		3 months
Primary	Recommended Phase II Dose(RP2D)		2 months
Secondary	Objective response rate(ORR)	Proportion of subjects with complete response (CR) or partial response (PR).	6 months
Secondary	Disease Control Rate(DCR)	Proportion of subjects with complete response (CR), partial response (PR), or stable disease (SD).	6 months
Secondary	Time to Objective Response (TTR)	Time from randomization to first objective tumor response (CR or PR).	6 months
Secondary	Duration of Response (DoR)	The time from the first documented objective tumor response (CR or PR) to objective disease progression (PD) or death.	6 months
Secondary	Progression-free survival(PFS)	The time from randomization to the first occurrence of objective disease progression or death	6 months
Secondary	Area under the plasma concentration-time curve (AUC)		24 hours
Secondary	Maximum concentration (Cmax)		24 hours
Secondary	Trough concentration (Cmin)		24 hours
Secondary	Clearance (CL)		24 hours
Secondary	Volume of distribution (V)		24 hours
Secondary	Half-life (t1/2)		24 hours