NCT05200273

A Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK114

A Phase 1a, Multicenter, Open-label, Dose-escalation Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK114 in Subjects With Advanced or Metastatic Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Akeso · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Phase 1 study to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary antitumor activity of AK114.

Detailed description

This is a first-in-human (FIH), Phase 1a, multicenter, open-label, single-arm dose-escalation study of AK114 to evaluate the safety, tolerability, PK, pharmacodynamics, antitumor activity and immunogenicity in adult subjects with advanced or metastatic solid tumors. The study is comprised of dose escalation phase. Approximately 30 subjects will be treated in this study.

Conditions

• Advanced or Metastatic Solid Tumors
• Malignancy
• Metastasis

Interventions

Type	Name	Description
DRUG	AK114	AK114 administered by subcutaneous injection

Timeline

• Start date: 2022-03-15
• Primary completion: 2023-12-30
• Completion: 2023-12-30
• First posted: 2022-01-20
• Last updated: 2022-01-20

Locations

1 site across 1 country: Australia