A Study of ASKG915 in Patients With Selected Advanced Solid Tumors.
NCT05867420 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 594
Last updated 2026-01-27
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.
Conditions
Interventions
- DRUG
-
Docetaxel is administered intravenously at 75 mg/m², once every 3 weeks on a 21-day cycle.
- 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
-
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.
Sponsors & Collaborators
-
Jiangsu Aosaikang Pharmaceutical Co., Ltd.
collaborator INDUSTRY -
AskGene Pharma, Inc.
lead INDUSTRY
Principal Investigators
-
Jing Chen, MD · Ask-Gene Pharma, Inc.
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-08-02
- Primary Completion
- 2026-12-31
- Completion
- 2028-06-30
- FDA Drug
- Yes
Countries
- United States
- China
Study Locations
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