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

• ClinicalTrials.gov Identifier: NCT04258033
• Recruitment Status: Recruiting
• First Posted: February 6, 2020
• Last Update Posted: February 6, 2020
• Sponsor: Beijing Pearl Biotechnology Limited Liability Company
• Information provided by (Responsible Party): Beijing Pearl Biotechnology Limited Liability Company

Tracking Information

• First Submitted Date: February 3, 2020
• First Posted Date: February 6, 2020
• Last Update Posted Date: February 6, 2020
• Actual Study Start Date: January 17, 2020
• Estimated Primary Completion Date: December 31, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 5, 2020)

Objective response rate [ Time Frame: 2 years ]

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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: February 5, 2020)

• Progression free survival [ Time Frame: 2 years ]
  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.
• Overall survival [ Time Frame: 4 years ]
  Overall survival is defined as the time (in months) from first trial treatment administration to the date of death.
• Disease control rate [ Time Frame: 2 years ]
  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).
• Time to response [ Time Frame: 2 years ]
  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.
• Duration of response [ Time Frame: 2 years ]
  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.
• Occurrence of Treatment emergent adverse event (TEAEs) [ Time Frame: 2 years ]
  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.
• Maximum Plasma concentration (Cmax) of drug [ Time Frame: Cycle 1, Day 1 and on Cycle 1, Day 15 ]
  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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of PLB1001 in Non-small Cell Lung Cancer With c-Met Dysregulation
• 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
• Brief 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.
• Detailed 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.
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Non-small Cell Lung Cancer

Intervention

Drug: PLB1001

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

Other Name: Bozitinib

Study Arms

Experimental: PLB1001

Subjects will receive 200mg of PLB1001 twice daily in cycles of 28-day duration until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.

Intervention: Drug: PLB1001

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: February 5, 2020): 185
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2024
• Estimated Primary Completion Date: December 31, 2022 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Weizhe Xue, Ph. D; +86-10-84148931; xueweizhe@pearlbio.cn

• Listed Location Countries: China

Administrative Information

• NCT Number: NCT04258033
• Other Study ID Numbers: PLB1001-II-NSCLC-01
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Beijing Pearl Biotechnology Limited Liability Company
• Study Sponsor: Beijing Pearl Biotechnology Limited Liability Company
• Collaborators: Not Provided

Investigators

• Principal Investigator: Yilong Wu, MD; Guangdong Provincial People's Hospital

• PRS Account: Beijing Pearl Biotechnology Limited Liability Company
• Verification Date: February 2020