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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    185
  • sponsor
    Beijing Pearl Biotechnology Limited Liability Company
Updated on 19 February 2024
measurable disease
stage iv non-small cell lung cancer
small cell lung cancer

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.

Description

PLB1001 will be administrated 200mg twice daily. The treatment will be discontinued for the patients who experience disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent. A cycle of study treatment will be defined as 28 days of continuous dosing. The study includes 4 cohorts.

Details
Condition Non-Small Cell Lung Cancer, Non-Small Cell Lung Cancer
Age 18-100 years
Treatment PLB1001
Clinical Study IdentifierNCT04258033
SponsorBeijing Pearl Biotechnology Limited Liability Company
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

Signed Informed Consent Form
Age18 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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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