NCT06046495 A Study of the Oral EGFR Inhibitor PLB1004 in Non-Small Cell Lung Cancer
| NCT ID | NCT06046495 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Avistone Biotechnology Co., Ltd. |
| Condition | Non-Small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 81 participants |
| Start Date | 2024-07-08 |
| Primary Completion | 2028-02-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 81 participants in total. It began in 2024-07-08 with a primary completion date of 2028-02-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Ability to understand and willingness to sign a written informed consent document; 2. Male or female adult patients 18 years of age or older; 3. Patients should have recovered from toxicities related to prior anti-tumor therapy; 4. Patients should have recovered from the effects of major surgery; 5. Have a documented EGFR mutation by a local test in tissue or plasma; 6. At least 12 weeks life expectancy; 7. Must have at least one measurable lesion per RECIST v 1.1; 8. Sexually active males and females of childbearing potential must agree to take effective contraceptive measures. Exclusion Criteria: 1. Received radiotherapy within 14 days before enrollment; 2. Have significant or uncontrolled systemic disease; 3. Have significant or uncontrolled cardiovascular disease; 4. Have had other diagnosed malignant diseases that required treatment within the past 3 years besides NSCLC; 5. Currently have or had a history of interstitial lung disease, drug-induced interstitial lung disease, or radiation pneumonia that requires steroid therapy; 6. Have known hypersensitivity to the similar drugs and excipients of PLB1004; 7. Pregnant or lactating women; 8. Have used other experimental drugs within 2 weeks prior to the first dose of PLB1004; 9. Have any condition or illness that could affect the compliance with the protocol.
Contact & Investigator
Avistone Clinical Study Information Center Center
✉ information.center@avistonebio.com📞 +86-10-84148921
Frequently Asked Questions
Who can join the NCT06046495 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non-Small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06046495 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06046495 currently recruiting?
Yes, NCT06046495 is actively recruiting participants. Contact the research team at information.center@avistonebio.com for enrollment information.
Where is the NCT06046495 trial being conducted?
This trial is being conducted at Sacramento, United States, Louisville, United States, Omaha, United States, New York, United States and 3 additional locations.
Who is sponsoring the NCT06046495 clinical trial?
NCT06046495 is sponsored by Avistone Biotechnology Co., Ltd.. The trial plans to enroll 81 participants.
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