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
The study is a Phase 1, open-label, multicenter, dose escalation study to evaluate the safety, tolerability, PK and PD of ASKG315 as a single agent in patients with advanced solid tumors.
Each part of the study consists of 3 periods: screening (up to 28 days), treatment and follow-up. After an initial screening period, ASKG315 will be administered once every 3 weeks by intravenous (IV) infusion. The Part 1 dose escalation consists of 6 planned escalation cohorts, with a starting dose of 3 mg.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASKG315 | Experimental | Single or multiple ascending dose of ASKG315 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASKG315 | Biological | Injection with dose escalation stage of 3mg up to 45mg as well as dose expansion stage with recommended dose level from dose escalation stage. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose limiting toxicities (DLTs) | To evaluate the safery of ASKG315 in subjects. | 21days |
| Adverse events(AEs) | To evaluate the safery of ASKG315 in subjects. | 21days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) | To evaluate the systemic pharmacokinetics of ASKG315 in subjects. | 21days |
| Area under the concentration time curve (AUC) | To evaluate the systemic pharmacokinetics of ASKG315 in subjects. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Chen, MD | Contact | 086-15895835292 | chenjing@ask-pharm.com | |
| Luwei Han | Contact | 086- 15195873396 | hanluwei@ask-pharm.com |
| Name | Affiliation | Role |
|---|---|---|
| Jin Li, MD | Shanghai East Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harbin Medical University Cancer Hospital | Not yet recruiting | Harbin | Heilongjiang | China |
There is no plan to make IPD or supporting information available.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 21days |
| Cytokine | Increase in circulating cytokine levels. | 21days |
| Immunocyte | Changes in immunocyte levels by flow cytometry. | 21days |
| the First Affiliated Hospital of Nanchang University | Recruiting | Nanchang | Jiangxi | China |
|
| Shandong cancer hospital | Recruiting | Jinan | Shandong | China |
|
| Shanghai East Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
|