Advanced Solid Tumors
Conditions
Keywords
PD-1/IL-15
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALASKG915
ASKG915 is administered intravenously at a scheduled dose. The drug was given once every 3 weeks or 4 weeks for a cycle.
DRUGPaclitaxel + 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.
DRUGFruquintinib
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.
DRUGDocetaxel
Docetaxel is administered intravenously at 75 mg/m², once every 3 weeks on a 21-day cycle.
Sponsors
AskGene Pharma, Inc.
Jiangsu Aosaikang Pharmaceutical Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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. 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
1. Patients have received antitumor therapy during the first 4 weeks before study drug use. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose limiting toxicities (DLTs) | 21days or 28 days | To evaluate the safery of ASKG915 in subjects. |
| Adverse events(AEs) | From the first dose to 30 days after the last dose | To evaluate the safery of ASKG915 in subjects. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum plasma concentration (Cmax) | Until treatment discontinuation or for a maximum of 2 years | To evaluate the systemic pharmacokinetics of ASKG915 in subjects. |
| Area under the concentration time curve (AUC) | Until treatment discontinuation or for a maximum of 2 years | To evaluate the systemic pharmacokinetics of ASKG915 in subjects. |
| Plasma clearance rate (CL) | Until treatment discontinuation or for a maximum of 2 years | To evaluate the systemic pharmacokinetics of ASKG915 in subjects. |
| Evaluation of immunogenicity | Until treatment discontinuation or for a maximum of 2 years | Incidence of anti-drug antibodies (ADA) |
| Objective Response Rate (ORR) | Until disease progression or for a maximum of 2 years | The percentage of patients having a best overall response of complete response (CR) or partial response (PR) |
| Duration of response (DOR) | Until disease progression or for a maximum of 2 years | The DOR will be calculated from the time of initial response (PR or better that is subsequently confirmed) to progression (after PR) or death |
| Progression-free survival (PFS) | Until disease progression or for a maximum of 2 years | 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 |
Countries
China, United States
Contacts
CONTACTMedical Director
CONTACTChief Executive Officer
STUDY_DIRECTORJing Chen, MD
Ask-Gene Pharma, Inc.
Outcome results
None listed