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

NCT05757492 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: CHS-006-01
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 4

Brief 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

Advanced Solid Tumor; Non-Small Cell Lung Cancer; Hepatocellular Carcinoma

Keywords

TIGIT inhibitor; PD-1 inhibitor; Advanced Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Assessment of the number of participants with treatment-emergent adverse events (TEAEs) receiving CHS-006 administered in combination with toripalimab

  Assessed by number of participants with TEAEs assessed by the investigator as per CTCAE v5.0.

  Day 1 of study treatment through up to 90 days post last dose of study treatment

Secondary Outcomes (8)

• Description of the PK profile of CHS-006 in combination with toripalimab

  Measured at multiple timepoints from Day 1 of study treatment through up to 90 days post last dose of study treatment

• Immunogenicity of CHS-006 and/or toripalimab

  Measured at multiple timepoints from Day 1 of study treatment through up to 90 days post last dose of study treatment

• Objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 assessed by the investigator

  Measured at multiple timepoints from Day 1 of study treatment through +/- 7 days at the completion of or premature withdrawal from the study

• Duration of response (DoR) using RECIST v1.1 assessed by the investigator

  Measured at multiple timepoints from Day 1 of study treatment through +/- 7 days at the completion of or premature withdrawal from the study

• Disease control rate (DCR) using RECIST v1.1 assessed by the investigator

  Measured at multiple timepoints from Day 1 of study treatment through +/- 7 days at the completion of or premature withdrawal from the study

Study Arms (4)

Dose Optimization Phase - Arm A

ACTIVE COMPARATOR

Advanced solid tumor participants will receive CHS-006 in combination with toripalimab Q3W

Drug: CHS-006 (anti-TIGIT); Drug: toripalimab (anti-PD-1)

Dose Optimization Phase - Arm B

ACTIVE COMPARATOR

Advanced solid tumor participants will receive CHS-006 in combination with toripalimab Q3W

Drug: CHS-006 (anti-TIGIT); Drug: toripalimab (anti-PD-1)

Indication-specific Expansion Phase - Cohort 1 NSCLC-NS

ACTIVE COMPARATOR

NSCLC-NS participants will receive CHS-006 in combination with toripalimab Q3W

Drug: CHS-006 (anti-TIGIT); Drug: toripalimab (anti-PD-1)

Indication-specific Expansion Phase - Cohort 2 HCC

ACTIVE COMPARATOR

HCC participants will receive CHS-006 in combination with toripalimab Q3W

Drug: CHS-006 (anti-TIGIT); Drug: toripalimab (anti-PD-1)

Interventions

CHS-006 (anti-TIGIT) DRUG

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

Also known as: JS006

Dose Optimization Phase - Arm A; Dose Optimization Phase - Arm B; Indication-specific Expansion Phase - Cohort 1 NSCLC-NS; Indication-specific Expansion Phase - Cohort 2 HCC

toripalimab (anti-PD-1) DRUG

Arm B participants will receive toripalimab administered via IV Q3W.

Also known as: CHS-007, TAB001, JS001

Dose Optimization Phase - Arm A; Dose Optimization Phase - Arm B; Indication-specific Expansion Phase - Cohort 1 NSCLC-NS; Indication-specific Expansion Phase - Cohort 2 HCC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Coherus Oncology, Inc.: lead
• Medpace, Inc.: collaborator
• Shanghai Junshi Bioscience Co., Ltd.: collaborator

Study Sites (4)

University of Florida Health Cancer Center

Orlando, Florida, 32806, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Renown Institute for Cancer

Reno, Nevada, 89502, United States

Location

Gabrail Cancer and Research Center

Canton, Ohio, 44718, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Carcinoma, Hepatocellular

Interventions

toripalimab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Liver Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a Phase 1, open-label, multiple-phase, multiple phase study. Participants within the advanced solid tumor dose optimization phase will be assigned to one of two dosing arms. After one CHS-006 dose has been selected from Phase 1, Phase 2 participants will be dosed with that dose in combination with toripalimab.

Study Record Dates

• First Submitted: January 2, 2023
• First Posted: March 7, 2023
• Study Start: April 26, 2023
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: May 1, 2025

Record last verified: 2025-04

Locations

US (4)