At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 37 enrolled
Drug / intervention
PLB1001drug
Likely dose
PLB1001 25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I Open-label, Multicenter Dose Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics (PK) of PLB1001 in Patients With Met-positive (Met+) Advanced Non-small Cell Lung Cancer (NSCLC)
Beijing Pearl Biotechnology Limited Liability Company·interventional·Posted Sep 12, 2016·Updated Nov 22, 2019
In Brief
A Phase 1 clinical trial evaluating PLB1001 for Non-Small Cell Lung Cancer. Completed, enrolled 37 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Small Cell Lung Cancer
CountriesChina
Collaborators--
Timeline
Phase 1CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartApr 2016
First PostedSep 2016
Primary CompletionOct 2019
TodayJul 2026
First PostedSep 12, 2016
Enrollment StartApr 1, 2016
Primary CompletionOct 1, 2019
TodayJul 1, 2026
Enrollment to primary: 3.5 yearsPosted 9.8 years ago
Interventions
PLB1001drug
PLB1001 is a capsule in the form of 25 mg and 100mg, twice daily.