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

NCT03130881 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-03-04

No results posted yet for this study

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

Interventions

DRUG

PLB1003

PLB1003 is a capsule and is administered orally.

Sponsors & Collaborators

  • Beijing Pearl Biotechnology Limited Liability Company

    lead INDUSTRY

Principal Investigators

  • Baohui Han, MD · Shanghai Chest Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-08
Primary Completion
2020-12-30
Completion
2021-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03130881 on ClinicalTrials.gov