A Study of ASKG915 in Patients With Selected Advanced Solid Tumors.

Study Overview
=================
Brief Summary
-----------------
The study is a Phase 1dose escalation study to evaluate the safety, tolerability, and pharmacokinetics of ASKG915 as a single agent in patients with selected advanced solid tumors.

Detailed Description
-----------------
A two-part, dose-escalation and expansion study of ASKG915 was initiated to determine the safety, tolerability, PK and PD.

Official Title
-----------------
A Phase 1 Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ASKG915 as a Single Agent in Patients With Selected Advanced Solid Tumors.

Conditions
-----------------
Advanced Solid Tumors

Intervention / Treatment
-----------------
* Biological: ASKG915


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically confirmed advanced malignant tumor that is refractory to or intolerant of all standard therapy or for which no standard therapy is available. ECOG performance status of ≤ 2. Life expectancy of ≥ 3 months. The results of the laboratory tests must meet all criteria. Exclusion Criteria: Patients have received antitumor therapy during the first 4 weeks before study drug use. Received a live attenuated vaccine within 4 weeks prior to C1D1. Known cerebral parenchymal metastasis or meningeal metastasis. History of serious cardiovascular or cerebrovascular diseases. Active or recurrent autoimmune diseases. History of ascites or pleural effusion requiring drainage. Pregnant or lactating or planning to become pregnant at any time during the study, including the Follow-up Period.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASKG915<br>Single or multiple ascending dose of ASKG915. | Biological: ASKG915<br>* ASKG915 is administered intravenously at a fixed dose. The drug was given once every 3 weeks for a cycle.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose limiting toxicities (DLTs) | To evaluate the safery of ASKG915 in subjects. | 21days | 
| Adverse events(AEs) | To evaluate the safery of ASKG915 in subjects. | 21days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum plasma concentration (Cmax) | To evaluate the systemic pharmacokinetics of ASKG915 in subjects. | 21days | 
| Area under the concentration time curve (AUC) | To evaluate the systemic pharmacokinetics of ASKG915 in subjects. | 21days | 
| Plasma clearance rate (CL) | To evaluate the systemic pharmacokinetics of ASKG915 in subjects. | 21days | 
| Evaluation of immunogenicity | Incidence of anti-drug antibodies (ADA) | Up to 2 years from date of treatment start until data cut-off |