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Trial Title:
A Study of ASKG915 in Patients With Selected Advanced Solid Tumors.
NCT ID:
NCT05867420
Condition:
Advanced Solid Tumors
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
ASKG915
Description:
ASKG915 is administered intravenously at a fixed dose. The drug was given once every 3
weeks for a cycle.
Arm group label:
ASKG915
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. 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.
2. ECOG performance status of ≤ 2.
3. Life expectancy of ≥ 3 months.
4. The results of the laboratory tests must meet all criteria.
Exclusion Criteria:
1. Patients have received antitumor therapy during the first 4 weeks before study drug
use.
2. Received a live attenuated vaccine within 4 weeks prior to C1D1.
3. Known cerebral parenchymal metastasis or meningeal metastasis.
4. History of serious cardiovascular or cerebrovascular diseases.
5. Active or recurrent autoimmune diseases.
6. History of ascites or pleural effusion requiring drainage.
7. Pregnant or lactating or planning to become pregnant at any time during the study,
including the Follow-up Period.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Columbia University Irving Medical Center
Address:
City:
New York
Zip:
10032
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mark Stein, MD
Facility:
Name:
UPMC Hillman Cancer Center
Address:
City:
Pittsburgh
Zip:
15232
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jason Luke, MD
Start date:
August 3, 2023
Completion date:
December 2025
Lead sponsor:
Agency:
AskGene Pharma, Inc.
Agency class:
Industry
Collaborator:
Agency:
Jiangsu Aosaikang Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
AskGene Pharma, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05867420
