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

STATUS

Recruiting
participants needed

185
sponsor

Beijing Pearl Biotechnology Limited Liability Company

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Updated on 19 February 2024

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measurable disease

stage iv non-small cell lung cancer

small cell lung cancer

Summary

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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	18years - 100years
Treatment	PLB1001
Clinical Study Identifier	NCT04258033
Sponsor	Beijing Pearl Biotechnology Limited Liability Company
Last Modified on	19 February 2024

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