A Study of ASKG915 in Patients With Selected Advanced Solid Tumors.
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|ClinicalTrials.gov Identifier: NCT05867420|
Recruitment Status : Not yet recruiting
First Posted : May 22, 2023
Last Update Posted : May 22, 2023
AskGene Pharma, Inc.
Jiangsu Aosaikang Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
AskGene Pharma, Inc.
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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|
|Advanced Solid Tumors||Biological: ASKG915||Phase 1|
|Study Type :||Interventional|
|Estimated Enrollment :||104 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Estimated Study Start Date :||June 2023|
|Estimated Primary Completion Date :||December 2024|
|Estimated Study Completion Date :||December 2025|
Single or multiple ascending dose of ASKG915.
ASKG915 is administered intravenously at a fixed dose. The drug was given once every 3 weeks for a cycle.
Primary Outcome Measures :
- Dose limiting toxicities (DLTs) [ Time Frame: 21days ]To evaluate the safery of ASKG915 in subjects.
- Adverse events(AEs) [ Time Frame: 21days ]To evaluate the safery of ASKG915 in subjects.
Secondary Outcome Measures :
- Maximum plasma concentration (Cmax) [ Time Frame: 21days ]To evaluate the systemic pharmacokinetics of ASKG915 in subjects.
- Area under the concentration time curve (AUC) [ Time Frame: 21days ]To evaluate the systemic pharmacokinetics of ASKG915 in subjects.
- Plasma clearance rate (CL) [ Time Frame: 21days ]To evaluate the systemic pharmacokinetics of ASKG915 in subjects.
- Evaluation of immunogenicity [ Time Frame: Up to 2 years from date of treatment start until data cut-off ]Incidence of anti-drug antibodies (ADA)
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
No Contacts or Locations Provided
|Responsible Party:||AskGene Pharma, Inc.|
|Other Study ID Numbers:||
|First Posted:||May 22, 2023 Key Record Dates|
|Last Update Posted:||May 22, 2023|
|Last Verified:||May 2023|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Additional relevant MeSH terms: