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2022-07-07
2027-08-31
2027-08-31
180
NCT06245330
Ascentawits Pharmaceuticals, Ltd
Ascentawits Pharmaceuticals, Ltd
INTERVENTIONAL
A Phase I/II Study of AST-001 in Subjects With Advanced Solid Tumors
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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2024-01-10 | N/A | 2024-01-31 |
2024-01-31 | N/A | 2024-02-07 |
2024-02-07 | N/A | 2024-01 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Non Randomized
Interventional Model:
Sequential
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Dose escalation phase 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. | DRUG: AST-001
|
| EXPERIMENTAL: phase II pancreatic cancer AST-001 (RP2D) will be administered by IV infusion on Days 1, 8 and 15 of each 28-day cycle | DRUG: AST-001
|
| Primary Outcome Measures | 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) | 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) |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Claire Hao Phone Number: (0086)13207649065 Email: claire.hao@ascentawitspharm.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
