RecruitingPhase 1NCT06657144

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

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 (TREGCHECK 102)


Sponsor

Coherus Oncology, Inc.

Enrollment

154 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing CHS-114 — a new experimental drug — combined with toripalimab (an immunotherapy) and/or other cancer treatments in patients with advanced solid tumors (cancers that have spread and have not responded to standard treatments). **You may be eligible if...** - You have advanced solid tumor cancer with at least one measurable tumor on imaging - Any side effects from prior cancer treatments have resolved to mild or baseline levels - You are in adequate overall health and your organ function meets study requirements - You are willing to undergo biopsies and study procedures **You may NOT be eligible if...** - You have active, uncontrolled brain metastases - You have serious autoimmune disease or are on high-dose immune-suppressing medications - You have had certain prior immunotherapy treatments that conflict with this study - You have serious heart, liver, or kidney problems Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCHS-114

Solution for infusion

DRUGToripalimab

Solution for infusion

DRUG5 Fluorouracil

Solution for infusion

DRUGCisplatin

Solution for infusion


Locations(30)

The University of Arizona Cancer Center

Tucson, Arizona, United States

City of Hope

Duarte, California, United States

University of Colorado - Aurora Cancer Center

Aurora, Colorado, United States

Winship Cancer Center - Emory University

Atlanta, Georgia, United States

Ochsner Health

New Orleans, Louisiana, United States

Henry Ford Health System

Detroit, Michigan, United States

Comprehensive Cancer Center of Nevada

Las Vegas, Nevada, United States

Christus St Vincent Regional Medical Center

Santa Fe, New Mexico, United States

START New York

Lake Success, New York, United States

David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

New York, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

University of Pittsburg Medical Center _UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Prisma Health Cancer Institute

Greenville, South Carolina, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

Texas Oncology - Central South

Austin, Texas, United States

START San Antonio, LLC.

San Antonio, Texas, United States

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, United States

START Mountain Region, LLC.

West Valley City, Utah, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Virginia Oncology Associates

Norfolk, Virginia, United States

Changhua Christian Hospital

Chang-hua, Taiwan

E-Da Cancer Hospital

Kaohsiung City, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

China Medical University Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

Chi Mei Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Mackay Memorial Hospital

Taipei, Taiwan

View Full Details on ClinicalTrials.gov

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NCT06657144


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