NCT05867420 · AskGene Pharma, Inc.
A Study of ASKG915 in Patients With Selected Advanced Solid Tumors.
What this study is about
The study is a gradually increasing doses and dose-expansion study to evaluate the safety, tolerability, and how the drug moves through the body of ASKG915 as a single agent or in combination with the usual treatment (SOC) in patients with selected types of advanced solid tumors.
View original scientific description
The study is a dose-escalation and dose-expansion study to evaluate the safety, tolerability, and pharmacokinetics of ASKG915 as a single agent or in combination with standard of care (SOC) in patients with selected types of advanced solid tumors.
Interventions
BIOLOGICAL
ASKG915
ASKG915 is administered intravenously at a scheduled dose. The drug was given once every 3 weeks or 4 weeks for a cycle.
DRUG
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.
DRUG
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.
DRUG
Docetaxel
Docetaxel is administered intravenously at 75 mg/m², once every 3 weeks on a 21-day cycle.
Primary outcome measures
Dose limiting toxicities (DLTs)
Time frame: 21days or 28 days
To evaluate the safery of ASKG915 in subjects.
Adverse events(AEs)
Time frame: From the first dose to 30 days after the last dose
To evaluate the safery of ASKG915 in subjects.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion 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.
Where
- New York, New York
- Pittsburgh, Pennsylvania
Collaborators
Jiangsu Aosaikang Pharmaceutical Co., Ltd.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 27, 2026 · Source of record for eligibility and locations