NCT05867420

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

A Phase 1 Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ASKG915 in Patients With Selected Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 594 (estimated)
• Sponsor: AskGene Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-08-02
• Primary completion: 2026-12-31
• Completion: 2028-06-30
• First posted: 2023-05-22
• Last updated: 2026-01-27

Locations

4 sites across 2 countries: United States, China

Regulatory

• FDA-regulated drug study