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

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

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.