A Study of ASKG915 in Patients With Selected Advanced Solid Tumors.
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
Detailed Description
A two-part, dose-escalation and expansion study of ASKG915 was initiated to determine the safety, tolerability, PK and PD.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: ASKG915 Single or multiple ascending dose of ASKG915. |
Biological: ASKG915
ASKG915 is administered intravenously at a fixed dose. The drug was given once every 3 weeks for a cycle.
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Outcome Measures
Primary Outcome Measures
- Dose limiting toxicities (DLTs) [21days]
To evaluate the safery of ASKG915 in subjects.
- Adverse events(AEs) [21days]
To evaluate the safery of ASKG915 in subjects.
Secondary Outcome Measures
- Maximum plasma concentration (Cmax) [21days]
To evaluate the systemic pharmacokinetics of ASKG915 in subjects.
- Area under the concentration time curve (AUC) [21days]
To evaluate the systemic pharmacokinetics of ASKG915 in subjects.
- Plasma clearance rate (CL) [21days]
To evaluate the systemic pharmacokinetics of ASKG915 in subjects.
- Evaluation of immunogenicity [Up to 2 years from date of treatment start until data cut-off]
Incidence of anti-drug antibodies (ADA)
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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ECOG performance status of ≤ 2.
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Life expectancy of ≥ 3 months.
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The results of the laboratory tests must meet all criteria.
Exclusion Criteria:
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Patients have received antitumor therapy during the first 4 weeks before study drug use.
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Received a live attenuated vaccine within 4 weeks prior to C1D1.
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Known cerebral parenchymal metastasis or meningeal metastasis.
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History of serious cardiovascular or cerebrovascular diseases.
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Active or recurrent autoimmune diseases.
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History of ascites or pleural effusion requiring drainage.
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Pregnant or lactating or planning to become pregnant at any time during the study, including the Follow-up Period.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- AskGene Pharma, Inc.
- Jiangsu Aosaikang Pharmaceutical Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ASKG915-101