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

February 24, 2023 updated by: Innovent Biologics (Suzhou) Co. Ltd.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Bengbu, China
        • The First Affiliated Hospital of Bengbu Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion criteria

  1. 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.
  2. No EGFR mutation or ALK rearrangement.
  3. ECOG PS score 0 or 1.
  4. BMI ≥ 21.0kg/m2 and ≤ 26.0kg/m2
  5. Body weight ≥ 60.0kg and ≤ 75.0kg.
  6. Adequate organ function per protocol-defined criteria.

Exclusion criteria

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: sintilimab (M1b) 200mg
Drug: Sintilimab (M1b)
Intravenous infusion
Active Comparator: sintilimab (approved) 200mg
Drug: Sintilimab (approved)
Intravenous infusion

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2020

Primary Completion (Actual)

February 28, 2021

Study Completion (Actual)

September 4, 2022

Study Registration Dates

First Submitted

November 14, 2019

First Submitted That Met QC Criteria

November 24, 2019

First Posted (Actual)

November 26, 2019

Study Record Updates

Last Update Posted (Estimate)

February 27, 2023

Last Update Submitted That Met QC Criteria

February 24, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIBI308K101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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