NCT05645276

A Study of AK129 in Patients With Advanced Malignant Tumors

A Phase Ia/Ib, Open Label, Dose Escalation and Dose Extension Trial of Anti-PD-1 and LAG-3 Bispecific Antibody AK129 to Evaluate the Safety, Tolerability and Antitumor Efficacy in Patients With Advanced Malignant Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 182 (estimated)
• Sponsor: Akeso · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A Phase Ia/Ib, open label, dose escalation and dose extension trial of Anti-PD-1 and LAG-3 bispecific antibody, AK129, to evaluate the safety, tolerability and antitumor efficacy in patients with advanced malignant tumors

Detailed description

Anti Lymphocyte Activation Gene-3(LAG-3) combination therapy showed a preliminary antitumor signal in multiple solid tumors and hematologic tumor.LAG-3 targeted drug Relatilimab in a Phase 2/3 study comparing a combination of relatilimab and nivolumab to nivolumab alone in previously untreated patients with metastatic or unresectable melanoma.The combination therapy of Relatilimab with nivolumab showed a statistically significant and clinically significant progression-free survival(PFS) benefit compared to the nivolumab group, Because of this study, the FDA approved the combination therapy for first-line therapy of melanoma. AK129 is a humanized immunoglobulin G1(IgG1) bispecial antibody(BsAb), which can bind anti-programmed death receptor 1(PD-1) and LAG-3 at the same time, and block the interaction of PD-1/programmed cell death - ligand 1(PD-L1), LAG-3/ major histo-compatibility complex II(MHCII),etc. The aim of the first human, dose-escalation study of this investigational drug is to explore its safety, tolerability, and initial antitumor efficacy, and to evaluate its pharmacokinetic and pharmacokinetic characteristics to identify the appropriate dose and regimen.

Conditions

• Advanced Malignant Tumors(Stage IA-IB)

Interventions

Type	Name	Description
DRUG	AK129 IV infusion	AK129 is administered intravenously according to the frequency and dosage of administration at different stages.

Timeline

• Start date: 2023-03-02
• Primary completion: 2026-02-01
• Completion: 2026-06-01
• First posted: 2022-12-09
• Last updated: 2025-03-03

Locations

1 site across 1 country: China