First-in-human Phase I Study of a Selective c-Met Inhibitor PLB1001

NCT02896231 | Completed Phase 1

• 1 other identifier: HMO-PLB1001-2013012-01
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I, first-in-human dose-escalation study was conducted to determine the maximum tolerated dose (MTD), recommended phase II dose (RP2D), dose-limiting toxicities (DLTs), pharmacokinetics (PK) profile, and preliminary antitumor activity of PLB1001.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of participants with dose-limiting toxicities

  2 years

Secondary Outcomes (4)

• Area under the plasma concentration versus time curve (AUC) of PLB1001 and its metabolite

  Day 1-2 Single Dose and Day 1-28 Steady State

• Maximum plasma concentration observed (Cmax) of PLB1001 and its metabolite

  Day 1-2 Single Dose and Day 1-28 Steady State

• Time to Cmax (Tmax) of PLB1001 and its metabolite

  Day 1-2 Single Dose and Day 1-28 Steady State

• Preliminary antitumor activity of PLB1001

  2 years

Study Arms (1)

PLB1001

EXPERIMENTAL

There are 5 dose cohorts, including 50mg BID, 100mg BID, 150mg BID, 200mg BID and 275mg BID in the dose escalation stage and PLB1001 will be administered orally to patients twice daily for each dose cohort.

Drug: PLB1001

Interventions

PLB1001 DRUG

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

Also known as: Bozitinib

PLB1001

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent Form
• Age≥18 years
• Histologically or cytologically confirmed advanced non-small cell lung cancer
• Must have evidence of c-Met positivity 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 0-2

You may not qualify if:

• Previous or current treatment with a c-Met inhibitor or HGF-targeting therapy
• 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) ≥ 140 mm Hg and/or Diastolic Blood Pressure (DBP) ≥ 90 mm Hg Arrhythmias
• Active peptic ulcer disease or gastritis
• 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 4 weeks before first dose of PLB1001. If previous treatment is a monoclonal antibody, then the treatment must be discontinued at least 6 weeks before first dose of PLB1001.
• Pregnant or nursing women
• Involved in other clinical trials \< 30 days prior to Day 1

Sponsors & Collaborators

• Beijing Pearl Biotechnology Limited Liability Company: lead

Study Sites (1)

Guangdong General Hospital

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yilong Wu, MD

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2016
• First Posted: September 12, 2016
• Study Start: April 1, 2016
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: November 22, 2019

Record last verified: 2017-10

Locations

CN (1)