A Study of the Oral EGFR Inhibitor PLB1004 in Non-Small Cell Lung Cancer
Study Details
Study Description
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. 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PLB1004 PLB1004 given as a mono-therapy in dose escalation and dose expansion phase. |
Drug: PLB1004
PLB1004 will be orally self-administered by the patient as a mono-therapy.
|
Outcome Measures
Primary Outcome Measures
- Safety profile of PLB1004 per CTCAE v5.0 [Up to 2 years]
Secondary Outcome Measures
- To define the DLTs and MTD [Up to 3 years]
- Area Under the Curve (AUC) of PLB1004 [Approximately 28 days.]
- Maximum plasma concentration (Cmax) of PLB1004 [Approximately 28 days.]
- Time to maximum plasma concentration (Tmax) of PLB1004 [Approximately 28 days.]
- Overall Response Rate (ORR) [Up to 3 years]
- Progression-Free Survival (PFS) [Up to 3 years]
- Overall Survival (OS) [Up to 3 years]
- Disease Control Rate (DCR) [Up to 3 years]
- Duration of Response (DOR) [Up to 3 years]
- Change from baseline in corrected QT interval (QTc) using Fridericia formula (QTcF) [Up to 3 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Ability to understand and willingness to sign a written informed consent document;
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Male or female adult patients 18 years of age or older;
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Patients should have recovered from toxicities related to prior anti-tumor therapy;
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Patients should have recovered from the effects of major surgery;
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Have a documented EGFR in-frame exon 20 insertion mutation by a local test in tissue or plasma;
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At least 12 weeks life expectancy;
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Must have at least one measurable lesion per RECIST v 1.1;
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Sexually active males and females of childbearing potential must agree to take effective contraceptive measures.
Exclusion Criteria:
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Received radiotherapy within 14 days before enrollment;
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Have significant or uncontrolled systemic disease;
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Have significant or uncontrolled cardiovascular disease;
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Have had other diagnosed malignant diseases that required treatment within the past 3 years besides NSCLC;
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Currently have or had a history of interstitial lung disease, drug-induced interstitial lung disease, or radiation pneumonia that requires steroid therapy;
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Have known hypersensitivity to the similar drugs and excipients of PLB1004;
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Pregnant or lactating women;
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Have used other experimental drugs within 2 weeks prior to the first dose of PLB1004;
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Have any condition or illness that could affect the compliance with the protocol.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Nebraska Cancer Specialists | Omaha | Nebraska | United States | 68130 |
Sponsors and Collaborators
- Avistone Biotechnology Co., Ltd.
Investigators
- Study Director: Weizhe Xue, Ph.D, Avistone Biotechnology Co., Ltd.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PLB1004-I-US01