A Study of ASKG315 in Patients With Advanced Solid Tumors.
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|ClinicalTrials.gov Identifier: NCT05554666|
Recruitment Status : Not yet recruiting
First Posted : September 26, 2022
Last Update Posted : September 26, 2022
AskGene Pharma, Inc.
Jiangsu Aosaikang Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
AskGene Pharma, Inc.
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.
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumors||Biological: ASKG315||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||56 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 ASKG315 as a Single Agent in Patients With Locally Advanced or Metastatic Malignant Solid Tumors.|
|Estimated Study Start Date :||October 2022|
|Estimated Primary Completion Date :||October 2023|
|Estimated Study Completion Date :||October 2024|
Single or multiple ascending dose of ASKG315
Injection with dose escalation stage of 3mg up to 45mg as well as dose expansion stage with recommended dose level from dose escalation stage.
Primary Outcome Measures :
- Dose limiting toxicities (DLTs) [ Time Frame: 21days ]To evaluate the safery of ASKG315 in subjects.
- Adverse events(AEs) [ Time Frame: 21days ]To evaluate the safery of ASKG315 in subjects.
Secondary Outcome Measures :
- Maximum plasma concentration (Cmax) [ Time Frame: 21days ]To evaluate the systemic pharmacokinetics of ASKG315 in subjects.
- Area under the concentration time curve (AUC) [ Time Frame: 21days ]To evaluate the systemic pharmacokinetics of ASKG315 in subjects.
- Cytokine [ Time Frame: 21days ]Increase in circulating cytokine levels.
- Immunocyte [ Time Frame: 21days ]Changes in immunocyte levels by flow cytometry.
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