NCT03950297

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. · Industry
• Sex: All
• Age: 18 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

Detailed description

This is a first-in-human (FIH), open-label, phase 1 dose-escalation study of 609A, a recombinant monoclonal anti-PD-1 antibody product, in subjects with Locally advanced/Metastatic Solid Tumors, who must have received, or be intolerant to all available approved or standard therapies known to confirm clinical benefit, or for whom no standard therapy exits.

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: 2019-05-01
• Primary completion: 2020-10-24
• Completion: 2022-05-24
• First posted: 2019-05-15
• Last updated: 2020-04-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study