NCT05277402

ADG116 in Combination With Pembrolizumab in Patients With Advanced/Metastatic Solid Tumors

A Phase 1b, Open-Label, Dose Escalation Study of ADG116 in Combination With Pembrolizumab (Anti-PD-1 Antibody) in Patients With Advanced/Metastatic Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Adagene Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1b, open-label, dose escalation study to evaluate the safety, tolerability, PK, and immunogenicity of an ADG116-pembrolizumab combination regimen in patients with advanced/metastatic solid tumors. Study drug ADG116, is an anti -CTLA-4 fully human monoclonal antibody that specifically binds to human CTLA-4. Pembrolizumab is a PD-1 receptor-blocking antibody (a humanized IgG4 monoclonal antibody) which is indicated for the treatment of patients across a number of indications. The treatment strategy of using anti-PD 1 therapy combined with anti-CTLA-4 therapy is to explore the potential of combination checkpoint inhibition regimens for the enhanced antitumor efficacy results.

Conditions

• Advanced/Metastatic Solid Tumors

Interventions

Type	Name	Description
DRUG	ADG116	IV infusion

Timeline

• Start date: 2022-02-09
• Primary completion: 2022-08-01
• Completion: 2022-12-01
• First posted: 2022-03-14
• Last updated: 2024-02-26

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study