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A first-in-human open-label, Phase I/II study to evaluate the safety, tolerability, MTD/RP2D, PK, and preliminary efficacy of AST-001 administered as a single agent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose escalation phase | Experimental | AST-001 (5.0 mg/m^2 to 40.0 mg/m^2) will be administered by IV infusion on Days 1, 8 and 15 of each 28-day cycle to determine the MTD and RP2D with a BOIN design. |
|
| phase II pancreatic cancer | Experimental | AST-001 (RP2D) will be administered by IV infusion on Days 1, 8 and 15 of each 28-day cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AST-001 | Drug | liquid formulation for Intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events (AEs) | Adverse events will be graded according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0. | Adverse events will be noted as it occurs. Timeframe for measure begins after informed consent until 30 days after last dose of study drug. |
| Assess safety changes in electrocardiogram (ECG) | Resting 12-lead ECGs will be obtained from all subjects' pre-AST-001 infusion and within 30 minutes post-AST-001 infusion in order to assess any impact AST-001 may have on the QT interval as assessed by the Fridericia's Correction Formula (QTcF). | Day 1 of each cycle(there are 26 cycles; 28 days for each cycle) |
| Assess safety changes of body weight. | If during treatment a subject's body weight changes by >10%, the dose should be adjusted. | pre-AST-001 infusion of each cycle (there are 26 cycles; 28 days for each cycle) |
| Number of participants with dose limiting toxicities (DLTs) | A DLT is defined as the occurrence of Grade 3/4 adverse events within the first cycle (the first 28 days) of treatment that are considered by the investigator to be at least possibly related to AST-001. | Throughout Cycle 1 (28 days for each cycle) |
| Define the Recommended Phase 2 Dose (RP2D) | Determination of the MTD, based on the frequently of DLTs observed in Cycle 1 in subjects recruited to the Dose Escalation Phase. | Days 1, 8 and 15 of each cycle (all 26 cycles and there are 28 days for each cycle) |
| Pharmacokinetics (PK) - Time to maximum concentration (Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
History of another primary malignancy within 2 years prior to Day 1, except for adequately treated basaloma, in situ cancer, or other cancers whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the current study.
Major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1.
Treatment with radiation therapy, chemotherapy, biotherapy, targeted therapies or hormones within 4 weeks prior to Day 1.
Receiving investigational therapy within 4 weeks prior to Day 1.
Concomitant use of repaglinide, medium/strong CYP2C8/CYP2B6/ CYP2C9 inhibitors/inducers.
Pleural effusion or ascites which need to be drained every other week or more frequently.
HBV infection and HBV-DNA ≥ 2,000 IU/mL
Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
History of human immunodeficiency virus (HIV) infection or syphilis infection.
History of cardiac disease fits any of the following conditions：
Females who are pregnant or breast-feeding
Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
Previously allergic to ethanol, polyoxyethylene (35) castor oil, N, N-dimethylacetamide.
Unwillingness or inability to comply with the study protocol for any reason
Inclusion Criteria:
Exclusion Criteria:
History of another primary malignancy within 2 years prior to Day 1, except for adequately treated basaloma, in situ cancer, or other cancers whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the current study.
Major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1.
Treatment with radiation therapy, chemotherapy, biotherapy, targeted therapies or hormones within 4 weeks prior to Day 1.
Receiving investigational therapy within 4 weeks prior to Day 1.
Concomitant use of repaglinide, medium/strong CYP2C8/CYP2B6/ CYP2C9 inhibitors/inducers.
Pleural effusion or ascites which need to be drained every other week or more frequently.
HBV infection and HBV-DNA ≥ 2,000 IU/mL
Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
History of human immunodeficiency virus (HIV) infection or syphilis infection.
History of cardiac disease fits any of the following conditions：
Females who are pregnant or breast-feeding
Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
Previously allergic to ethanol, polyoxyethylene (35) castor oil, N, N-dimethylacetamide.
Unwillingness or inability to comply with the study protocol for any reason
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Claire Hao | Contact | (0086)13207649065 | claire.hao@ascentawitspharm.com |
| Name | Affiliation | Role |
|---|---|---|
| Ying Cheng | Study Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jinlin Cancer Hospital | Recruiting | Changchun | Jinlin | 130000 | China |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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Tmax of AST-001 and AST-2660 will be computed for each subject where possible
| Days 1 and 15 of Cycle 1 (first cycle of 26 cycles and there are 28 days for each cycle) |
| PK - Maximum peak plasma concentration (Cmax) | Cmax of AST-001 and AST-2660 will be computed for each subject where possible. | Days 1 and 15 of Cycle 1 (first cycle of 26 cycles and there are 28 days for each cycle) |
| PK - Area under the concentration-time curve (AUClast) PK - Area under the concentration-time curve (AUClast) | AUClast from Hour 0 through the last quantifiable concentration time (LQCT), where LQCT is the time at which the last sample with a quantifiable concentration was drawn | Days 1 and 15 of Cycle 1 (first cycle of 26 cycles and there are 28 days for each cycle) |
| PK - Half-life (T1/2) | T1/2 computed as ln (2)/Kel of AST-001 and AST-2660 will be computed for each subject where possible. | Days 1 and 15 of Cycle 1 (first cycle of 26 cycles and there are 28 days for each cycle) |
| Efficacy: Objective response rate(ORR) | ORR will be assessed as a primary outcome in phase II. | up to 26 cycles (there are 28 days for each cycle) |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |