NCT04363242

A Study to Find the MTD of SYN125 in People With Solid Tumors and the MTD of SYN125 With a Fixed Dose of SYN004 in People in Patients With Epithelial Cancers With EGFR Expressions

A Phase 1 Dose Escalation Trial of SYN125 Single Agent in Solid Tumors and in Combination With Fixed Dose SYN004 in Patients With Epithelial Cancers With EGFR Expressions.

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Synermore Biologics Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Phase 1 Dose Escalation Trial of SYN125 Single Agent in the Treatment of Solid Tumors and in Combination With Fixed Dose SYN004 in Patients With Cancer of the Internal or External Lining of the Body.

Detailed description

Humans have an immune system that can protect and fight infections and abnormal cells. T-cells are a type of cell produced by the body that can attack and kill cancer cells. Unfortunately, many cancer cells have ways preventing T-cells from working properly. SYN125 and SYN004 can make T-cells work again. This is a study to find the maximum tolerated dose of SYN125 when it is used as a single treatment (Part A) for solid tumors, and when it is used as a combined treatment with a fixed dose of SYN004 (Part B), in patients with epithelial cancers with EGFR (epithelial growth factor receptor) expressions.

Conditions

• Epithelial Carcinoma
• Solid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	SYN125	Administered by IV infusion
BIOLOGICAL	SYN004	Administered by IV infusion

Timeline

• Start date: 2020-04-09
• Primary completion: 2023-07-31
• Completion: 2023-09-30
• First posted: 2020-04-27
• Last updated: 2023-04-12

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study