A PK Similarity Study of Two Sintilimab Products Produced... | NCT04177290

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

NCT04177290

Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Status

Completed

Last Update Posted

Feb 27, 2023Actual

Enrollment

48Actual

Phase

Phase 1

Conditions

Advanced or Metastatic NSCLC

Interventions

Sintilimab (M1b)
Sintilimab (approved)

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2, 2020Actual

Primary Completion Date

Feb 28, 2021Actual

Completion Date

Sep 4, 2022Actual

First Submitted Date

Nov 14, 2019

First Submission Date that Met QC Criteria

Nov 24, 2019

First Posted Date

Nov 26, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 24, 2023

Last Update Posted Date

Feb 27, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
sintilimab (M1b) 200mg	Experimental		Drug: Sintilimab (M1b)
sintilimab (approved) 200mg	Active Comparator		Drug: Sintilimab (approved)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sintilimab (M1b)	Drug	Intravenous infusion	sintilimab (M1b) 200mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PK is defined as AUC0-∞.		28 days

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria

Histologically or cytologically confirmed locally advanced, recurrent or metastatic NSCLC patients who have received or been intolerant to at least one prior line of standard treatment.
No EGFR mutation or ALK rearrangement.
ECOG PS score 0 or 1.
BMI ≥ 21.0kg/m2 and ≤ 26.0kg/m2
Body weight ≥ 60.0kg and ≤ 75.0kg.
Adequate organ function per protocol-defined criteria.

Exclusion criteria

Exposure to any anti-PD-1, PD-L1, PD-L2 antibodies.
Allergic to any component of sintilimab.
Active autoimmune diseases.
Clinically unstable central nervous system metastasis.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The First Affiliated Hospital of Bengbu Medical College		Bengbu			China

Condition Browse Module

MeSH Terms

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000632826	sintilimab

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided