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Clinical Trials in the USA / NCT05867420
Recruiting Phase 1/2

A Study of ASKG915 in Patients With Selected Advanced Solid Tumors.

NCT05867420 · tracked via the Priya Life Science USA tracker
Sponsor
AskGene Pharma, Inc.
Phase
Phase 1/2
Started
2023-08-02
Last updated
2026-01-27

Condition(s) studied

Advanced Solid Tumors

Investigational drug(s) / intervention(s)

ASKG915Paclitaxel + BevacizumabFruquintinibDocetaxel

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
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.

Primary outcome measure(s)

Trial sites (4)

FacilityCityRegionStatus
Columbia University Irving Medical Center New York New York Recruiting
UPMC Hillman Cancer Center Pittsburgh Pennsylvania Recruiting
Peking University Cancer Hospital Beijing Beijing Municipality Not Yet Recruiting
Fudan University Shanghai Cancer Center Shanghai Shanghai Municipality Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05867420 on ClinicalTrials.gov ↗ ← All trials in the USA