RECRUITING

A Study of CHS-114 in Combination With Toripalimab and/or Other Treatments in Participants With Advanced Solid Tumors

Conditions

Metastatic Solid Tumor Advanced Solid Tumor Solid Tumors Advanced Solid Tumors Cancer Oncology Tumor CCR8 PD-1

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The main purpose of this study is to evaluate the safety and preliminary efficacy of CHS-114 in combination with toripalimab and/or other standard of care (SOC) compound(s) in participants with advanced or metastatic solid tumors.

Official Title

A Phase 1B, Multicenter, Open-Label Study of the Safety and Efficacy of CHS-114 in Combination With Toripalimab With or Without Other Treatments in Participants With Advanced or Metastatic Solid Tumors

Quick Facts

Study Start:2025-04-01

Study Completion:2027-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06657144

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* At least 1 measurable lesion based on RECIST v1.1 as determined by the Investigator. * Resolved acute effects of any prior therapy to baseline severity or Grade 1 in accordance with National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) v5.0, except for adverse events (AEs) not constituting a safety risk per Investigator judgement. * Histologically or cytologically documented unresectable, locally advanced or metastatic gastric adenocarcinoma or adenocarcinoma of gastro-esophageal-junction (GEJ) human epidermal growth factor receptor 2 (HER2)- negative and microsatellite stable (MSS)/proficient mismatch repair (pMMR). * Progressed during or after first line systemic therapy that includes a platinum and fluoropyrimidine doublet with or without anti-programmed death receptor 1 (PD-1)/programmed death ligand 1 (PD-L1)-directed therapy (that is, in the second line setting). * Consent to provide tumor tissue samples (baseline and on-treatment) is required for enrollment.	* History of prior malignancy other than the cancer under study that is progressing or has required active treatment within the past 3 years. * Symptomatic or untreated central nervous system metastases, including leptomeningeal metastases, requiring concurrent treatment, including but not limited to surgery, radiation, and/or corticosteroids. * Major surgery requiring general anesthesia within 28 days prior to the first dose of study treatment, still recovering from prior surgery, or with surgery scheduled during the study. * Prior exposure to anti-C-C motif chemokine receptor 8 (CCR8) antibody. * History of Grade 4 allergic or anaphylactic reaction to any monoclonal antibody (mAb) therapy or any excipient in the study treatment. * Active uncontrolled bacterial, fungal, or viral infection including hepatitis B virus (HBV), hepatitis C virus (HCV), known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness. * Any condition that, in the opinion of the Investigator or Sponsor, would interfere with the interpretation of study results. * Received ≥ 2 prior systemic anticancer therapies for advanced or metastatic disease.

Inclusion Criteria

Exclusion Criteria

* At least 1 measurable lesion based on RECIST v1.1 as determined by the Investigator.
* Resolved acute effects of any prior therapy to baseline severity or Grade 1 in accordance with National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) v5.0, except for adverse events (AEs) not constituting a safety risk per Investigator judgement.
* Histologically or cytologically documented unresectable, locally advanced or metastatic gastric adenocarcinoma or adenocarcinoma of gastro-esophageal-junction (GEJ) human epidermal growth factor receptor 2 (HER2)- negative and microsatellite stable (MSS)/proficient mismatch repair (pMMR).
* Progressed during or after first line systemic therapy that includes a platinum and fluoropyrimidine doublet with or without anti-programmed death receptor 1 (PD-1)/programmed death ligand 1 (PD-L1)-directed therapy (that is, in the second line setting).
* Consent to provide tumor tissue samples (baseline and on-treatment) is required for enrollment.

* History of prior malignancy other than the cancer under study that is progressing or has required active treatment within the past 3 years.
* Symptomatic or untreated central nervous system metastases, including leptomeningeal metastases, requiring concurrent treatment, including but not limited to surgery, radiation, and/or corticosteroids.
* Major surgery requiring general anesthesia within 28 days prior to the first dose of study treatment, still recovering from prior surgery, or with surgery scheduled during the study.
* Prior exposure to anti-C-C motif chemokine receptor 8 (CCR8) antibody.
* History of Grade 4 allergic or anaphylactic reaction to any monoclonal antibody (mAb) therapy or any excipient in the study treatment.
* Active uncontrolled bacterial, fungal, or viral infection including hepatitis B virus (HBV), hepatitis C virus (HCV), known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
* Any condition that, in the opinion of the Investigator or Sponsor, would interfere with the interpretation of study results.
* Received ≥ 2 prior systemic anticancer therapies for advanced or metastatic disease.

Contacts and Locations

Study Contact

Senior Director, Clinical Operations

CONTACT

+1-800-794-5434

spaige@coherus.com

Study Locations (Sites)

Prisma Health Cancer Institute

Greenville, South Carolina, 29605

United States

Collaborators and Investigators

Sponsor: Coherus Biosciences, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-01

Study Completion Date2027-05

Study Record Updates

Study Start Date2025-04-01

Study Completion Date2027-05

Terms related to this study

Keywords Provided by Researchers

Solid Tumors
Advanced Solid Tumors
Metastatic Solid Tumor
Cancer
Oncology
Tumor
CCR8
PD-1

Additional Relevant MeSH Terms

Metastatic Solid Tumor
Advanced Solid Tumor