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

Non-small Cell Lung Cancer Clinical Trial

— KUNPENG  

Official title:

A Phase II, Open-label, Multicenter and Multi-cohorts Study to Evaluate the Efficacy and Safety of PLB1001 in Advanced Non-small Cell Lung Cancer With c-Met Dysregulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04258033
• Other study ID #: PLB1001-II-NSCLC-01
• Status: Recruiting
• Phase: Phase 2
• Start date: January 17, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2023
• Source: Beijing Pearl Biotechnology Limited Liability Company
• Contact: Weizhe Xue, Ph. D
• Phone: +86-10-84148931
• Email: xueweizhe[@]pearlbio.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 185
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• PLB1001
PLB1001 is a capsule in the form of 25 mg and 100mg, twice daily.

Locations

Country	Name	City	State
China	Guangdong General Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Pearl Biotechnology Limited Liability Company

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate	Objective response rate will be determined according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Objective response rate is defined as the percentage of patients who experienced either a complete response (CR) or partial response (PR) from first administration of trial treatment to first observation of progressive disease (PD). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD is defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.	2 years
Secondary	Progression free survival	Progression free survival is defined as the time (in months) from the first administration of trial treatment to the date of the first documentation of PD or death due to any cause. PD is defined as at least a 20 % increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.	2 years
Secondary	Overall survival	Overall survival is defined as the time (in months) from first trial treatment administration to the date of death.	4 years
Secondary	Disease control rate	Disease control rate according to RECIST 1.1 is the percentage of patients who experienced either a complete response (CR), partial response (PR) or stable disease (SD).	2 years
Secondary	Time to response	Time to response according to RECIST 1.1 is the time from the first trial treatment administration to the CR/PR (whichever is first) criteria are first met. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD is defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.	2 years
Secondary	Duration of response	Duration of response according to RECIST 1.1 is the time from when the CR/PR (whichever is first) criteria are first met until progression of disease (PD) or death due to any cause. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD is defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.	2 years
Secondary	Occurrence of Treatment emergent adverse event (TEAEs)	This outcome measure will be presented as the percentage of subjects with any (serious) adverse event (AE). Percentages are calculated using total number of subjects per treatment cohort as the denominator.	2 years
Secondary	Maximum Plasma concentration (Cmax) of drug	In the study some Pharmacokinetics (PK) profiles of PLB1001 will be obtained following administration of PLB-1001 at pre-dose and at the 0.5, 2, 4, 6,10 hours time points on Cycle 1, Day 1 and on Cycle 1, Day 15.	Cycle 1, Day 1 and on Cycle 1, Day 15