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

Advanced or Metastatic NSCLC Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04177290
• Other study ID #: CIBI308K101
• Status: Completed
• Phase: Phase 1
• Start date: April 2, 2020
• Est. completion date: September 4, 2022

Study information

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

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 4, 2022
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced or Metastatic NSCLC
• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• Sintilimab (M1b)
Intravenous infusion
• Sintilimab (approved)
Intravenous infusion

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Bengbu Medical College	Bengbu

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	PK is defined as AUC0-8.		28 days
Secondary	PK is defined as Cmax.		28 days
Secondary	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