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

Innovent Biologics

Status and phase: Completed; Phase 1

Conditions: Advanced or Metastatic NSCLC

Treatments: Drug: Sintilimab (approved); Drug: Sintilimab (M1b)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04177290

CIBI308K101

Details and patient eligibility

About

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

Enrollment: 48 patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

sintilimab (M1b) 200mg

Experimental group

Treatment:

Drug: Sintilimab (M1b)

sintilimab (approved) 200mg

Active Comparator group

Treatment:

Drug: Sintilimab (approved)