Phase I Study of a Selective ALK Inhibitor PLB1003 in Patients With ALK+ NSCLC.

NCT03130881 | Unknown Phase 1

• 1 other identifier: HMO-PLB1003-20160828
• Study Type: interventional
• Target: 60
• 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 PLB1003.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Dose Limiting Toxicities (DLTs) .

  The maximum tolerated dose (MTD) was defined as the highest dose for a given schedule that was expected to cause DLTs in no more than 33% of patients during the first cycle of treatment.

  18 months.

Secondary Outcomes (4)

• Area under the plasma concentration versus time curve (AUC) of PLB1003 and its metabolite.

  Day 1-3 PK Run-in period and Day 1-21 Treatment period

• Maximum plasma concentration observed (Cmax) of PLB1003 and its metabolite.

  Day 1-3 PK Run-in period and Day 1-21 Treatment period

• Time to Cmax (Tmax) of PLB1003 and its metabolite.

  Day 1-3 PK Run-in period and Day 1-21 Treatment period

• Preliminary antitumor activity of PLB1003.

  30 months.

Study Arms (1)

PLB1003

EXPERIMENTAL

ALK-positive (ALK+) advanced NSCLC

Drug: PLB1003

Interventions

PLB1003 DRUG

PLB1003 is a capsule and is administered orally.

PLB1003

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
• Diagnosed with a locally advanced or metastatic non-small cell lung cancer that has progressed despite standard therapy.
• Must have evidence of ALK 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:

• 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 III-IV) .
• Active peptic ulcer disease or gastritis
• Major surgery within 4 weeks prior to starting PLB1003
• Previous anti-cancer and investigational agents within 4 weeks before first dose of PLB1003..
• 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)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

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

• Baohui Han, MD

  Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peilong Zhang, Ph.D

CONTACT

+86-10-64392756; zhangpeilong@pearlbio.cn

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: April 19, 2017
• First Posted: April 27, 2017
• Study Start: November 8, 2016
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2021
• Last Updated: March 4, 2020

Record last verified: 2017-04

Locations

CN (1)