NCT04374877

Study of CHS-388 (Formerly Known as SRF388) in Patients With Advanced Solid Tumors

A Phase 1/1b Study of CHS-388 (Formerly Known as SRF388) in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 145 (actual)
• Sponsor: Coherus Oncology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1/1b, open-label, first-in-human, dose-escalation and expansion study of CHS-388, a monoclonal antibody that targets IL-27, as a monotherapy and in combination in patients with solid tumors.

Detailed description

This is a Phase 1/1b, open-label, first-in-human (FIH), dose-escalation and expansion study of CHS-388, a monoclonal antibody targeting IL-27, as a monotherapy and in combination in patients with solid tumors that will be conducted in 4 parts: * Part A: CHS-388 monotherapy dose-escalation portion of the study will evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of CHS-388 as monotherapy in patients with advanced solid tumors. * Part B: CHS-388 monotherapy expansion cohorts will evaluate the safety, efficacy, tolerability, PK, and pharmacodynamics of CHS-388 monotherapy in patients with advanced or metastatic ccRCC, advanced or metastatic HCC, and advanced or metastatic NSCLC in indication specific cohorts. * Part C will evaluate the safety, preliminary efficacy, tolerability, and PK of CHS-388 in combination with pembrolizumab in patients with advanced RCC,HCC, or NSCLC. * Part D will evaluate the safety, preliminary efficacy, tolerability, and PK of CHS-388 in combination with toripalimab in patients with advanced NSCLC.

Conditions

• Advanced Solid Tumor
• Clear Cell Renal Cell Carcinoma
• Hepatocellular Carcinoma
• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	CHS-388	CHS-388 is a fully human IgG1 antibody against IL-27. Inhibition of IL-27 with CHS-388 reduces STAT1 phosphorylation leading to increased pro-inflammatory (anti-tumor) cytokine secretion (e.g., IFN-g, TNF-a) and decreased expression of inhibitory immune checkpoint receptors (e.g., PD-L1, TIGIT, LAG3) on immune cells that may result in anticancer therapeutic activity.
DRUG	Pembrolizumab	Pembrolizumab by intravenous (IV) infusion
DRUG	Toripalimab	Toripalimab by IV infusion

Timeline

• Start date: 2020-04-22
• Primary completion: 2025-05-28
• Completion: 2025-06-05
• First posted: 2020-05-05
• Last updated: 2025-11-10

Locations

23 sites across 3 countries: United States, Singapore, South Korea

Regulatory

• FDA-regulated drug study