Loading clinical trials...

Study to Evaluate Safety and PK of CHS-006 in Combination With Toripalimab in Patients With Advanced Solid Tumors | Clinical Trials | Clareo Health

TERMINATEDPHASE1

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

A Phase 1, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CHS-006, as Monotherapy and in Combination With Toripalimab, in Participants With Advanced Solid Tumors

NCT05757492•Coherus Oncology, Inc.

View on ClinicalTrials.gov

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 \[HCC\])

Detailed Description

The Dose Optimization phase will enroll participants with advanced/metastatic solid tumors (except pancreatic). Up to 20 participants will be randomized into two dosing arms. Two different primary advanced solid tumors have been selected for investigation of antitumor activity in the Indication-specific Expansion phase. Up to 40 participants will be enrolled into each Indication-specific Expansion phase cohort. All participants in both phases will receive CHS-006 in combination with toripalimab intravenously (IV) every 3 weeks (Q3W).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Males and females, ≥18 years old;
•Histopathologically or cytologically confirmed advanced solid tumor (except pancreatic) with disease progression after at least 1 prior line of standard therapy (Dose Optimization phase);
•Tumor-specific criteria (Indication-specific Expansion phase):
•NSCLC-NS (without sensitizing EGFR/ALK/ROS-1/MET mutations) 2nd line plus (2L+): has received and progressed on at least 1 prior chemotherapy regimen. Prior treatment with both anti-PD-1 therapy and platinum-based chemotherapy either concurrently or sequentially are eligible.
•Hepatocellular carcinoma (HCC) 2L+: has received and progressed on at least 1 prior anticancer regimen. Participants with prior treatment with an anti-PD-1 or PD-L1 agent are eligible.
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and expected survival ≥12 weeks;
•At least 1 measurable lesion per RECIST v1.1;
•Adequate organ and marrow function

Exclusion Criteria

•Current or prior use of systemic anticancer therapy, including but not limited to chemotherapy, immunotherapy, biologic therapy, hormone therapy, and targeted therapy, within 28 days prior to the 1st dose of CHS-006;
•NSCLC participants with genomic mutations (e.g., EGFR, ALK, ROS-1, MET, etc.) for which FDA-approved targeted therapies are available or require progression on appropriate prior to enrollment;
•Prior exposure to monoclonal antibodies (mAbs) targeting TIGIT or any of its ligands, including CD155, CD112, or CD113;
•Major surgery within 28 days prior to the 1st dose of CHS-006 or still recovering from prior surgery;
•Symptomatic or untreated central nervous system (CNS) metastases;
•Use of therapeutic immunosuppressive medication within 28 days prior to the 1st planned dose of CHS-006;
•Receipt of live, attenuated vaccination within 30 days prior to the 1st dose of CHS- 006;
•History of active autoimmune disease within the past 2 years, with the following exceptions: vitiligo, alopecia, endocrinopathies controlled by hormone replacement therapy, rheumatoid arthritis and other arthropathies that have not required immunosuppression other than nonsteroidal anti-inflammatory agents, celiac disease controlled by diet, or psoriasis controlled with topical medication;
•Participants with another active solid tumor that has not been curatively treated.

Locations (4)

University of Florida Health Cancer Center

Orlando, Florida, United States

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Renown Institute for Cancer

Reno, Nevada, United States

Gabrail Cancer and Research Center

Canton, Ohio, United States

Key Dates

Start Date

April 26, 2023

Primary Completion Date

July 31, 2024

Completion Date

July 31, 2024

Last Updated

May 1, 2025

Enrollment

ACTUAL participants

Conditions

Advanced Solid TumorNon-Small Cell Lung CancerHepatocellular Carcinoma

Interventions

CHS-006 (anti-TIGIT)

DRUG

toripalimab (anti-PD-1)

DRUG

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

NCT06066138

Locally Advanced Alveolar Soft Part SarcomaMetastatic Alveolar Soft Part Sarcoma+8 more

View study

RECRUITING

Early Detection of Liver Cancer by QUS

NCT06345508

Hepatocellular CarcinomaLiver Cancer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 1, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

Early Detection of Liver Cancer by QUS

Testing the Addition of an Anti-cancer Drug, Sapanisertib, to the Usual Chemotherapy Treatment (Cabozantinib) in Metastatic Liver Cell Cancer With a Change in Genes for the Protein β-Catenin, The SAPHIRE Trial

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)