Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Jiangsu Aosaikang Pharmaceutical Co., Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
The study is a dose-escalation and dose-expansion study to evaluate the safety, tolerability, and pharmacokinetics of ASKG915 as a single agent or in combination with standard of care (SOC) in patients with selected types of advanced solid tumors.
Monotherapy:
A dose-escalation (Part A) and expansion (Part B) study of ASKG915 monotherapy was initiated to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) in patients with advanced solid tumors.
Combination therapy:
A dose-optimization (Part C) srudy of ASKG915 in combination with standard of care (SOC) in patients was conducted to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) in patients with selected types of advanced solid tumors.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASKG915 | Experimental | For monotherapy (Part A and Part B), subjects will receive ASKG915 via intravenous (IV) infusion at a frequency of once every 3 weeks (Q3W) or once every 4 weeks (Q4W), at either the prespecified dose levels or the levels determined by the Study Review Committee (SRC). |
|
| ASKG915 combination with SOC | Experimental | For combination therapy phase (Part C), subjects will receive ASKG915 at recommended dose levels via intravenous (IV) infusion, administered once every 3 weeks (Q3W) or once every 4 weeks (Q4W), and in combination with the standard treatment regimen for the selected tumor types. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASKG915 | Biological | ASKG915 is administered intravenously at a scheduled dose. The drug was given once every 3 weeks or 4 weeks for a cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose limiting toxicities (DLTs) | To evaluate the safery of ASKG915 in subjects. | 21days or 28 days |
| Adverse events(AEs) | To evaluate the safery of ASKG915 in subjects. | From the first dose to 30 days after the last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) | To evaluate the systemic pharmacokinetics of ASKG915 in subjects. | Until treatment discontinuation or for a maximum of 2 years |
| Area under the concentration time curve (AUC) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Contact | 805-389-2956 | chenjing@ask-pharm.com | |
| Chief Executive Officer | Contact | 805-389-2956 | jeff.lu@ask-gene.com |
| Name | Affiliation | Role |
|---|---|---|
| Jing Chen, MD | Ask-Gene Pharma, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Irving Medical Center | Recruiting | New York | New York | 10032 | United States |
Not provided
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D000068258 | Bevacizumab |
| C000591844 | HMPL-013 |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Paclitaxel + Bevacizumab | Drug | Paclitaxel is administered intravenously at a dose of 80 mg/m², once weekly on a 21-day cycle. Bevacizumab is administered intravenously at dose of 15mg/kg, once every 3 weeks on a 21-day cycle. |
|
| Fruquintinib | Drug | The recommended dose of Fruquintinib is 5 mg orally once daily, with or without food for the first 21 days of each 28-day cycle. |
|
| Docetaxel | Drug | Docetaxel is administered intravenously at 75 mg/m², once every 3 weeks on a 21-day cycle. |
|
To evaluate the systemic pharmacokinetics of ASKG915 in subjects.
| Until treatment discontinuation or for a maximum of 2 years |
| Plasma clearance rate (CL) | To evaluate the systemic pharmacokinetics of ASKG915 in subjects. | Until treatment discontinuation or for a maximum of 2 years |
| Evaluation of immunogenicity | Incidence of anti-drug antibodies (ADA) | Until treatment discontinuation or for a maximum of 2 years |
| Objective Response Rate (ORR) | The percentage of patients having a best overall response of complete response (CR) or partial response (PR) | Until disease progression or for a maximum of 2 years |
| Duration of response (DOR) | The DOR will be calculated from the time of initial response (PR or better that is subsequently confirmed) to progression (after PR) or death | Until disease progression or for a maximum of 2 years |
| Progression-free survival (PFS) | PFS is defined as the time from the date of first dose of study treatment until the date of progressive disease or death, whichever is earlier | Until disease progression or for a maximum of 2 years |
| UPMC Hillman Cancer Center | Recruiting | Pittsburgh | Pennsylvania | 15232 | United States |
|
| Peking University Cancer Hospital | Not yet recruiting | Beijing | Beijing Municipality | 100089 | China |
|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 201321 | China |
|
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |