NCT03998345

Phase 1, First in Human, Open-Label, Dose-Escalation Study of 609A in China

A First-in-Human, Open-label, Phase 1 Dose-Escalation Study of 609A in Subjects With Locally Advanced/Metastatic Solid Tumors in China

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Phase 1, First in Human, Open-Label, Dose-Escalation Study of 609A in the Patients with Locally advanced/Metastatic Solid Tumors in China.

Detailed description

This is a first-in-human (FIH), open-label, phase 1 dose-escalation study of 609A in China, a recombinant monoclonal anti-PD-1 antibody product, in subjects with Locally advanced/Metastatic Solid Tumors, who must have failed standard treatment (disease progression or intolerance) or lack of standard treatment. If there is a driver gene variant, the subjects must have failed the standard treatment for the driver gene, and there is no other standard treatment.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	609A	609A is a recombinant anti-PD-1 humanized IgG4 kappa antibody that targets the human PD-1

Timeline

• Start date: 2020-07-25
• Primary completion: 2020-12-24
• Completion: 2020-12-30
• First posted: 2019-06-26
• Last updated: 2020-09-09

Locations

1 site across 1 country: China