A Phase 1/2 interventional study of ASKG915 and Paclitaxel + Bevacizumab in Advanced Solid Tumors, sponsored by AskGene Pharma, Inc.. Recruiting at 4 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-27.
Sponsored by AskGene Pharma, Inc. · Phase 1/2, Interventional, and Treatment
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.
Monotherapy:
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.
AskGene Pharma, Inc. is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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).
Biological: ASKG915
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.
Biological: ASKG915 · Drug: Paclitaxel + Bevacizumab · Drug: Fruquintinib · Drug: Docetaxel
ASKG915 is administered intravenously at a scheduled dose. The drug was given once every 3 weeks or 4 weeks for a cycle.
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.
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 is administered intravenously at 75 mg/m², once every 3 weeks on a 21-day cycle.
Dose limiting toxicities (DLTs)
To evaluate the safery of ASKG915 in subjects.
Time frame: 21days or 28 days
Adverse events(AEs)
To evaluate the safery of ASKG915 in subjects.
Time frame: From the first dose to 30 days after the last dose
Maximum plasma concentration (Cmax)
To evaluate the systemic pharmacokinetics of ASKG915 in subjects.
Time frame: Until treatment discontinuation or for a maximum of 2 years
Area under the concentration time curve (AUC)
To evaluate the systemic pharmacokinetics of ASKG915 in subjects.
Time frame: Until treatment discontinuation or for a maximum of 2 years
Plasma clearance rate (CL)
To evaluate the systemic pharmacokinetics of ASKG915 in subjects.
Time frame: Until treatment discontinuation or for a maximum of 2 years
Evaluation of immunogenicity
Incidence of anti-drug antibodies (ADA)
Time frame: Until treatment discontinuation or for a maximum of 2 years
Objective Response Rate (ORR)
The percentage of patients having a best overall response of complete response (CR) or partial response (PR)
Time frame: Until disease progression or for a maximum of 2 years
Duration of response (DOR)
The DOR will be calculated from the time of initial response (PR or better that is subsequently confirmed) to progression (after PR) or death
Time frame: Until disease progression or for a maximum of 2 years
Progression-free survival (PFS)
PFS is defined as the time from the date of first dose of study treatment until the date of progressive disease or death, whichever is earlier
Time frame: Until disease progression or for a maximum of 2 years
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AskGene Pharma, Inc.