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NCT06046495Not yet recruiting

A Study of the Oral EGFR Inhibitor PLB1004 in Non-Small Cell Lung Cancer

A Phase I Open-label, Multi-dose, Dose Escalation and Dose Expansion Study of the Oral EGFR Inhibitor PLB1004 in Non-Small Cell Lung Cancer
Avistone Biotechnology Co., Ltd.Phase 1ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Non-Small Cell Lung Cancer
Drug/Device/Intervention
PLB1004
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Avistone Biotechnology Co., Ltd.
Location
Omaha, United States of America
Timeline & enrollment
Phase
Phase 1
Start date
Sep 29, 2023
End date
Feb 09, 2028
Enrollment
82 participants
Primary outcome

Safety profile of PLB1004 per CTCAE v5.0

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. 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. Part 2 includes an expansion phase and patient allocation to two
 dose levels with 20 patients per cohort.

ICD-10 classifications
Secondary malignant neoplasm of lungMalignant neoplasm: Lower lobe, bronchus or lungMalignant neoplasm: Middle lobe, bronchus or lungMalignant neoplasm: Bronchus or lung, unspecifiedMalignant neoplasm of bronchus and lung
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06046495
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06046495 through Pure Global AI's free database. This Phase 1 trial is sponsored by Avistone Biotechnology Co., Ltd. and is currently Not yet recruiting. The study focuses on Non-Small Cell Lung Cancer. Target enrollment is 82 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.