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OpenTrials
Completed

NCT Number: NCT04177290

A 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

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Key information

Conditions

Advanced or Metastatic NSCLC Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

The First Affiliated Hospital of Bengbu Medical College

Bengbu, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sintilimab (M1b)

Drug

Intravenous infusion

Sintilimab (approved)

Drug

Intravenous infusion

Primary outcomes

  1. PK is defined as AUC0-∞.

    Time frame: 28 days

Secondary outcomes

  1. PK is defined as Cmax.

    Time frame: 28 days

  2. 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

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Nov 26, 2019
Registry last updated
Feb 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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