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NotableTrial status: Active, Not Recruiting to RecruitingStart date: Nov 29, 2023 to Jul 1, 2024 · Enrollment target: 82 to 81 · Eligibility criteria shortened, about 46 words · 1 morev4Show 4 more changesShow less
MinorTrial status: Not Yet Recruiting to Active, Not RecruitingStudy sites: 1 to 4 · Start date changed from estimate of Sep 29, 2023 to Nov 29, 2023 · Eligibility criteria expanded, about 42 wordsv2Show 3 more changesShow less
Study sites: 1 to 4
Start date changed from estimate of Sep 29, 2023 to Nov 29, 2023
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a Phase I, multicenter, open-label, dose escalation and dose expansion study to assess the safety and pharmacokinetic profile of PLB1004, a mono-anilino-pyrimidine compound, given alone in NSCLC patients with EGFR exon 20 insertion mutations，uncommon mutations, classical mutations (Ex19del and L858R), and drug-resistant mutation (T790M). Patients will be enrolled and dosed according to the most current protocol. This study is made of two Parts. Part 1 includes a dose escalation into 7 cohorts and patient allocation to these cohorts will be via slot allocation. Each cohort has a minimum of 3 and a maximum of 6 patients for a total of 21 - 42 patients. The patient population of the dose escalation phase will include patients with advanced NSCLC harboring EGFR classical mutations or Ex20ins mutations, or uncommon mutations. Part 2 includes an expansion phase and the expansion phase will explore one or more dose levels of PLB1004 in NSCLC patients with EGFR Ex20ins mutations, classical mutations, or uncommon mutations.