A Study of PLB1001 in Non-small Cell Lung Cancer With c-Met Dysregulation

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase II, open-label, multicenter and multi-cohorts study of PLB1001 administered orally twice daily to locally advanced/metastatic NSCLC patients with c-Met dysregulation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Pearl Biotechnology Limited Liability Company

Criteria

Inclusion Criteria:

• Signed Informed Consent Form

• Age≥18 years

• Histologically or cytologically confirmed advanced non-small cell lung cancer

• Must have evidence of c-Met dysregulation from the results of molecular pre-screening evaluations

• At least one measurable lesion as per RECIST v1.1

• Patients must have recovered from all toxicities related to prior anticancer therapies to grade ≤ 1

• ECOG Performance Status of 0-1.

Exclusion Criteria:

• Symptomatic central nervous system (CNS) metastases that are neurologically unstable or requiring increasing doses of steroids to control, and patients with any CNS deficits.

• Clinically significant, uncontrolled heart diseases Unstable angina History of documented congestive heart failure (New York Heart Association functional classification > II) Uncontrolled hypertension defined by a Systolic Blood Pressure (SBP) ≥ 160 mm Hg and/or Diastolic Blood Pressure (DBP) ≥ 100 mm Hg Arrhythmias

• Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤ 1, except for alopecia

• Major surgery within 4 weeks prior to starting PLB1001

• Previous anti-cancer and investigational agents within 2 weeks before first dose of PLB1001. If previous treatment is a monoclonal antibody, then the treatment must be discontinued at least 4 weeks before first dose of PLB1001

• Pregnant or nursing women

• Involved in other clinical trials < 2 weeks prior to Day. If previous treatment of clinical trial is a monoclonal antibody, then the treatment must be discontinued at least 4 weeks before first dose of PLB1001.