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| Name | Class |
|---|---|
| CHA University | OTHER |
| National Cancer Center, Korea | OTHER_GOV |
| Samsung Medical Center | OTHER |
| Severance Hospital |
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This is the first in human trial clinical study of AST-201 in patients with GPC3-positive advanced solid tumors. This study aims to evaluate the safety, tolerability, pharmacokinetic properties, and preliminary efficacy of AST-201 across various tumor types.
AST-201 is a novel aptamer drug conjugate (ApDC) investigational agent with demonstrated preclinical efficacy in GPC3-positive tumor models. This Phase 1 clinical study aims to investigate the safety, tolerability, and preliminary efficacy of AST-201, targeting GPC3-positive advanced solid tumors. The study consists of two parts: Phase 1a and Phase 1b.
In Phase 1a, AST-201 will be administered in a dose escalating manner across cohorts of patients to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D). In this dose-escalation phase, patients will receive AST-201 as a single agent, with safety, tolerability, and pharmacokinetic (PK) profiles assessed. In Phase 1b, patients will receive AST-201 at the RP2D across specific GPC3-positive tumor types to further explore safety and efficacy. This expansion phase focuses on assessing anti-tumor efficacy and overall safety in a broader patient population. Data collected from this study will support future clinical development of AST-201 in GPC3-positive advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AST-201 | Experimental | Participants receive AST-201 administered intravenously according to the study dosing schedule. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AST-201 | Drug | AST-201 is administered intravenously on Days 1, 8, and 15 of each 28-day cycle, followed by a one-week rest period. Dosing is repeated until DLT or disease progression is occurred. |
| Measure | Description | Time Frame |
|---|---|---|
| Dose Limiting Toxicity (DLT) | Dose-limiting toxicity (DLT) is defined as any treatment-related Grade 3 or higher adverse event, or other clinically significant toxicity occurring during the first cycle (4 weeks), that meets the protocol-defined criteria for dose limitation, based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version [5.0]. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Cmax | Maximum Plasma Concentration (Cmax) | Cycle 1, Days 1-2 (cycle is 28 days) |
| Pharmacokinetics (PK): Tmax | Time to Reach Maximum Plasma Concentration (Tmax) |
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Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aptamer Sciences Inc. | Contact | +82-70-5067-4275 | kjkim@aptsci.com |
| Name | Affiliation | Role |
|---|---|---|
| David Lee | Aptamer Sciences, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center, Korea | Recruiting | Goyang-si | Gyeonggi-do | 10408 | South Korea |
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| OTHER |
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| Cycle 1, Days 1-2 (cycle is 28 days) |
| Pharmacokinetics (PK): AUC | Area Under the Curve (AUC) | Cycle 1, Days 1-2 (cycle is 28 days) |
| Pharmacokinetics (PK): Cl | Clearance Rate | Cycle 1, Days 1-2 (cycle is 28 days) |
| Pharmacokinetics (PK): t1/2 | Half-Life (t1/2) | Cycle 1, Days 1-2 (cycle is 28 days) |
| Objective Response Rate (ORR) | Objective Response Rate (ORR) is defined as the proportion of subjects with the best overall response (BOR) assessed as complete response (CR) and partial response (PR). ORR assessed by the Investigator and evaluated according to RECIST 1.1 criteria. | Baseline through the end of each 28-day cycle, up to 6 months. |
| Disease Control Rate (DCR) | Disease Control Rate (DCR) is defined as the proportion of subjects with the BOR assessed as CR, PR, or stable disease (SD). DCR assessed by the Investigator and evaluated according to RECIST 1.1 criteria. | Baseline through the end of each 28-day cycle, up to 6 months. |
| Duration of Response (DOR) | Duration of Response (DOR) is defined as the period from the initial assessment date confirming CR or PR to disease progression (PD) or death. DOR assessed by the Investigator and evaluated according to RECIST 1.1 criteria. | Baseline through the end of each 28-day cycle, up to 6 months. |
| Time to Progression (TTP) | Time to Progression (TTP) is defined as the period from the initial administration of the investigational product (IP) to disease progression (PD). TTP assessed by the Investigator and evaluated according to RECIST 1.1 criteria. | Baseline through the end of each 28-day cycle, up to 6 months. |
| Progression-Free Survival (PFS) | Progression-Free Survival (PFS) is defined as the period from the initial administration of the IP to disease progression (PD) or death. PFS assessed by the Investigator and evaluated according to RECIST 1.1 criteria. | Baseline through the end of each 28-day cycle, up to 6 months. |
| Overall Survival(OS) | Overall Survival(OS) is defined as the period from the initial administration of the IP to death. | Baseline through the end of each 28-day cycle, up to 6 months. |
| CHA Bundang Medical Center | Recruiting | Seongnam | 13609 | South Korea |
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| Severance Hospital | Recruiting | Seoul | 03722 | South Korea |
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| Samsung Medical Center | Recruiting | Seoul | 06351 | South Korea |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D006528 | Carcinoma, Hepatocellular |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008113 | Liver Neoplasms |
| C537340 | Simpson-Golabi-Behmel syndrome |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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