A Study of ASKG915 in Patients With Selected Advanced Solid Tumors.
NCT ID: NCT05867420
Last Updated: 2026-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
594 participants
INTERVENTIONAL
2023-08-02
2028-06-30
Brief Summary
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Detailed Description
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A dose-escalation (Part A) and expansion (Part B) study of ASKG915 monotherapy was initiated to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) in patients with advanced solid tumors.
Combination therapy:
A dose-optimization (Part C) srudy of ASKG915 in combination with standard of care (SOC) in patients was conducted to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) in patients with selected types of advanced solid tumors.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ASKG915
For monotherapy (Part A and Part B), subjects will receive ASKG915 via intravenous (IV) infusion at a frequency of once every 3 weeks (Q3W) or once every 4 weeks (Q4W), at either the prespecified dose levels or the levels determined by the Study Review Committee (SRC).
ASKG915
ASKG915 is administered intravenously at a scheduled dose. The drug was given once every 3 weeks or 4 weeks for a cycle.
ASKG915 combination with SOC
For combination therapy phase (Part C), subjects will receive ASKG915 at recommended dose levels via intravenous (IV) infusion, administered once every 3 weeks (Q3W) or once every 4 weeks (Q4W), and in combination with the standard treatment regimen for the selected tumor types.
ASKG915
ASKG915 is administered intravenously at a scheduled dose. The drug was given once every 3 weeks or 4 weeks for a cycle.
Paclitaxel + Bevacizumab
Paclitaxel is administered intravenously at a dose of 80 mg/m², once weekly on a 21-day cycle.
Bevacizumab is administered intravenously at dose of 15mg/kg, once every 3 weeks on a 21-day cycle.
Fruquintinib
The recommended dose of Fruquintinib is 5 mg orally once daily, with or without food for the first 21 days of each 28-day cycle.
Docetaxel
Docetaxel is administered intravenously at 75 mg/m², once every 3 weeks on a 21-day cycle.
Interventions
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ASKG915
ASKG915 is administered intravenously at a scheduled dose. The drug was given once every 3 weeks or 4 weeks for a cycle.
Paclitaxel + Bevacizumab
Paclitaxel is administered intravenously at a dose of 80 mg/m², once weekly on a 21-day cycle.
Bevacizumab is administered intravenously at dose of 15mg/kg, once every 3 weeks on a 21-day cycle.
Fruquintinib
The recommended dose of Fruquintinib is 5 mg orally once daily, with or without food for the first 21 days of each 28-day cycle.
Docetaxel
Docetaxel is administered intravenously at 75 mg/m², once every 3 weeks on a 21-day cycle.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Jiangsu Aosaikang Pharmaceutical Co., Ltd.
INDUSTRY
AskGene Pharma, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jing Chen, MD
Role: STUDY_DIRECTOR
Ask-Gene Pharma, Inc.
Locations
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Columbia University Irving Medical Center
New York, New York, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Peking University Cancer Hospital
Beijing, Beijing Municipality, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Mark Stein, MD
Role: primary
Jason Luke, MD
Role: primary
Other Identifiers
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ASKG915-101
Identifier Type: -
Identifier Source: org_study_id
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