A PK Similarity Study of Two Sintilimab Products Produced by Different Processes in Advanced or Metastatic NSCLC Patients

Phase 1

Completed

• Conditions: Advanced or Metastatic NSCLC
• Interventions: Drug: Sintilimab (approved); Drug: Sintilimab (M1b)

• Registration Number: NCT04177290
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Brief Summary

this is a phase I study comparing PK similarity of sintilimab by different production process (approved versus M1b) in Chinese advanced or metastatic NSCLC patients who have failed or been intolerant to at least one prior line of standard treatment

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-14
• Study First Submitted QC: 2019-11-24
• Study First Posted: 2019-11-26
• Study Start: 2020-04-02
• Primary Completion: 2021-02-28
• Study Completion: 2022-09-04
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-24
• Last Update Posted: 2023-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sintilimab (approved) 200mg	Sintilimab (approved)	-
sintilimab (M1b) 200mg	Sintilimab (M1b)	-

Primary Outcome Measures

Name	Time	Method
PK is defined as AUC0-∞.	28 days

Secondary Outcome Measures

Name	Time	Method
PK is defined as Cmax.	28 days
Safety of sintilimab (approved) versus sintilimab (M1b). AE is defined as treatment-related adverse events assessed by CTCAE v5.0.	from randomization through 90 days after last dosing

Trial Locations

Locations (1)

The First Affiliated Hospital of Bengbu Medical College; 🇨🇳 Bengbu, China