MedTrace Logo

Study to Evaluate Safety and PK of CHS-006 in Combination With Toripalimab in Patients With Advanced Solid Tumors

NCT05757492 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-05-01

No results posted yet for this study

Summary

This phase 1 open-label study will evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of CHS-006 in combination with toripalimab in 2 phases. Phase 1 (Dose Optimization phase) will explore 2 different dose combinations in participants with advanced/metastatic solid tumors (except pancreatic) and Phase 2 (Indication-specific Expansion phase) will use one selected dose in specific tumor types (non-small cell lung cancer-non squamous \[NSCLC-NS\] and Hepatocellular carcinoma \[HCC\])

Conditions

Interventions

DRUG

CHS-006 (anti-TIGIT)

Arm A participants will receive CHS-006 administered via IV Q3W.

DRUG

toripalimab (anti-PD-1)

Arm B participants will receive toripalimab administered via IV Q3W.

Sponsors & Collaborators

  • Medpace, Inc.

    collaborator INDUSTRY

  • Shanghai Junshi Bioscience Co., Ltd.

    collaborator OTHER

  • Coherus Oncology, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-26
Primary Completion
2024-07-31
Completion
2024-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT05757492 on ClinicalTrials.gov