At a glance
ClinicalIndex Comparison RecordPhase 1Unknown· 91 target
Drug / intervention
PLB1004drug
Likely dose
PLB1004 10mgfrom 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 and Dose Expansion Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Efficacy of PLB1004 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
In Brief
A Phase 1 clinical trial evaluating PLB1004 for Non-Small-Cell Lung Cancer. Targeting 91 participants across 1 site.
Detailed Summary
This is a phase I, open-label, multicenter study to assess the safety, tolerability, pharmacokinetics and preliminary antitumor activity of PLB1004, and to determine the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs) and recommended phase II dose (RP2D).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Small-Cell Lung Cancer
CountriesChina
Collaborators--
Timeline
Phase 1UnknownOverdue
202120222023202420252026
Enrollment StartAug 2020
First PostedApr 2022
Primary CompletionApr 2023
Study CompletionNov 2024
TodayJul 2026
First PostedApr 26, 2022
Enrollment StartAug 25, 2020
Primary CompletionApr 4, 2023
Study CompletionNov 30, 2024
TodayJul 1, 2026
Enrollment to primary: 2.6 yearsPosted 4.2 years ago
Interventions
PLB1004drug
PLB1004 is a capsule in the form of 10mg and 40mg.