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NCT06046495 · ClinicalTrials.gov registry record · Phase 1
A Study of the Oral EGFR Inhibitor PLB1004 in Non-Small Cell Lung Cancer
A Phase 1 study of Non-Small Cell Lung Cancer, sponsored by Avistone Biotechnology Co..
- Recruiting
- Registry status
- Phase 1
- Development phase
- 81
- Enrollment target
- 7
- Study locations
NCT06046495: Recruiting Phase 1 study of Non-Small Cell Lung Cancer, sponsored by Avistone Biotechnology Co..
NCT06046495 is a Phase 1 study of Non-Small Cell Lung Cancer that is actively recruiting participants, run by Avistone Biotechnology Co.. The registered enrollment target is 81 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (88% lower). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06046495, a Phase 1 study of Non-Small Cell Lung Cancer, is actively recruiting participants, sponsored by Avistone Biotechnology Co..
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 81 participants
- Enrollment target
- 7
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG PLB1004
Study Locations (7)
Washington
- Swedish Health Sciences - Seattle
- Research Site - Seattle
California
- University of California-Davis - Sacramento
Kentucky
- Research Site - Louisville
Nebraska
- Nebraska Cancer Specialists - Omaha
New York
- Research Site - New York
Tennessee
- Sarah Cannon Research Institute - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2024-07-08 |
| Est. Completion | 2028-02-09 |
| Phase | Phase 1 |
What NCT06046495 shows while recruiting
NCT06046495 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 1 intervention - of which PLB1004 is the first listed.
NCT06046495 lists 7 locations in 6 states (Washington, California, Kentucky).
Frequently Asked Questions
What is clinical trial NCT06046495 about?
NCT06046495 is a clinical study titled "A Study of the Oral EGFR Inhibitor PLB1004 in Non-Small Cell Lung Cancer". 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 a...
What is the current status of trial NCT06046495?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 81 participants. The study started on 2024-07-08. Estimated completion is 2028-02-09.
What conditions does trial NCT06046495 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer.
What interventions are being tested in trial NCT06046495?
The interventions under investigation include: PLB1004 (DRUG).
Who is sponsoring clinical trial NCT06046495?
This trial is sponsored by Avistone Biotechnology Co., which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06046495 being conducted?
This trial has 7 study locations across California, Kentucky, Nebraska, New York, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06046495's enrollment target sits among peer trials
81 269th of 454 higher than 186 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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