NCT05393063

A Study to Evaluate the Efficacy and Safety of AK127 in Patients With Advanced Solid Tumors

A Phase I Open-label Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of AK127 Monotherapy in Patients With Advanced Malignant Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Akeso · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is to characterize the safety, tolerability and anti-tumor activity of AK127 as a single agent in adult subjects with advanced solid tumor malignancies.

Detailed description

This study is to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of AK127 as a single agent in adult subjects with advanced solid tumor malignancies. The study, as a dose escalation phase is to determine the maximum tolerated dose (MTD), or recommended Phase 2 dose (RP2D) for AK127 as a single agent, and describe Dose Limiting Toxicity (DLT).

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	AK127	Subjects will receive AK127 by intravenous administration（administered on Day 1 of each cycle, Q3W）

Timeline

• Start date: 2022-06-01
• Primary completion: 2023-06-01
• Completion: 2024-06-01
• First posted: 2022-05-26
• Last updated: 2022-05-26