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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PLB1004 | Experimental | PLB1004 given as a mono-therapy in dose escalation and dose expansion phase. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PLB1004 | Drug | PLB1004 will be orally self-administered by the patient as a mono-therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety profile of PLB1004 per CTCAE v5.0 | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Avistone Clinical Study Information Center Center | Contact | +86-10-84148921 | information.center@avistonebio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California-Davis | Recruiting | Sacramento | California | 95817-1514 | United States |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| 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 |
| Research Site | Recruiting | Louisville | Kentucky | 40202 | United States |
| Nebraska Cancer Specialists | Recruiting | Omaha | Nebraska | 68130 | United States |
|
| Research Site | Recruiting | New York | New York | 100021 | United States |
| Sarah Cannon Research Institute | Recruiting | Nashville | Tennessee | 37203 | United States |
|
| Swedish Health Sciences | Recruiting | Seattle | Washington | 98122 | United States |
|
| Research Site | Recruiting | Seattle | Washington | 98195 | United States |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |