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

NCT04374877 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2025-11-10

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Koho Iizuka, MD · Coherus BioSciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-22
Primary Completion
2025-05-28
Completion
2025-06-05
FDA Drug
Yes

Countries

  • United States
  • Singapore
  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04374877 on ClinicalTrials.gov