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Studies

Interventional Recruiting Phase 1

NCT06657144 on ClinicalTrials.gov

A Study of CHS-114 (Tagmokitug) in Combination With Toripalimab and/or Other Treatments in Participants With Advanced 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 (TREGCHECK 102)

  • Sponsor: Coherus Oncology, Inc.
  • Enrollment: 154 (Estimated)
  • Study start: 2025-04-01 (Actual)
  • Primary completion: 2028-01-01 (Estimated)
  • Study completion: 2028-01-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: None
  • PrimaryPurpose: Treatment

Brief 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.

Conditions

  • Metastatic Solid Tumor
  • Advanced Solid Tumor

Intervention / Treatment

  • Drug: CHS-114
  • Drug: Toripalimab
  • Drug: 5 Fluorouracil
  • Drug: Cisplatin

Primary Outcome Measures

  • Number of Participants With Treatment-emergent Adverse Events (TEAEs) (From first dose of study drug until 90 days after the last dose of study drug (up to approximately 2.25 years))

Countries

Taiwan, United States

Locations and Investigators

  • The University of Arizona Cancer Center, Tucson, United States (Withdrawn)
  • City of Hope, Duarte, United States (Recruiting)
    • Edwin Smura
    • Dani Castillo, MD (Principal Investigator)
  • University of Colorado - Aurora Cancer Center, Aurora, United States (Recruiting)
    • Emily Harper
    • Sunnie Kim, MD (Principal Investigator)
  • Winship Cancer Center - Emory University, Atlanta, United States (Recruiting)
    • Kathleen Coleman
    • Oluwadunni Emiloju, MD (Principal Investigator)
  • Ochsner Health, New Orleans, United States (Recruiting)
    • Lauren Roddy
    • Jonathan Mizrahi, MD (Principal Investigator)
  • Henry Ford Health System, Detroit, United States (Recruiting)
    • Gazala Khan, MD (Principal Investigator)
  • Comprehensive Cancer Center of Nevada, Las Vegas, United States (Recruiting)
    • AnaArlene Ramirez
    • Kyaw Thein, MD (Principal Investigator)
  • Christus St Vincent Regional Medical Center, Santa Fe, United States (Recruiting)
    • Christopher Gallegos
    • Andrea Teague, MD (Principal Investigator)
  • START New York, Lake Success, United States (Recruiting)
    • Sadie Morium
    • Geraldine O'Sullivan Coyne, MD (Principal Investigator)
  • David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center, New York, United States (Recruiting)
    • Amin Yaqubie
    • Yelena Janjigian, MD (Principal Investigator)
  • Icahn School of Medicine at Mount Sinai, New York, United States (Recruiting)
    • Joseph Waters
    • Dan Feng, MD (Principal Investigator)
  • University of Pittsburg Medical Center _UPMC Hillman Cancer Center, Pittsburgh, United States (Recruiting)
    • Nicholas Kerin
    • Anwaar Saeed, MD (Principal Investigator)
  • Prisma Health Cancer Institute, Greenville, United States (Recruiting)
    • Jill Roemmich
    • Ki Chung, MD (Principal Investigator)
  • SCRI Oncology Partners, Nashville, United States (Recruiting)
    • Karlie Williams
    • Meredith S Pelster, MD (Principal Investigator)
  • Texas Oncology - Central South, Austin, United States (Recruiting)
    • Marian Heaven
    • Vivian Cline, MD (Principal Investigator)
  • START San Antonio, LLC., San Antonio, United States (Recruiting)
    • Isabel Jimenez
    • Amita Patnaik, MD (Principal Investigator)
  • Huntsman Cancer Institute, University of Utah, Salt Lake City, United States (Recruiting)
    • Jamie White
    • Christopher Nevala-Plagemann, MD (Principal Investigator)
  • START Mountain Region, LLC., West Valley City, United States (Recruiting)
    • Marie Asay
    • William McKean, MD (Principal Investigator)
  • Virginia Cancer Specialists, Fairfax, United States (Recruiting)
    • Marcy Sullivan
    • Mohamad A Salkeni, MD (Principal Investigator)
  • Virginia Oncology Associates, Norfolk, United States (Withdrawn)
  • Changhua Christian Hospital, Chang-hua, Taiwan (Recruiting)
    • Ai-Ping Lai
    • Kuan-Ming Lai, MD (Principal Investigator)
  • E-Da Cancer Hospital, Kaohsiung City, Taiwan (Recruiting)
    • Wei-Ching Liu
    • Meng-Che Hsieh, MD (Principal Investigator)
  • Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City, Taiwan (Recruiting)
    • Ya-Chieh Tsui
    • Jaw-Yuan Wang, MD (Principal Investigator)
  • Taichung Veterans General Hospital, Taichung, Taiwan (Recruiting)
    • Yi-Ru Lai
    • Hsin-Chen Lin, MD (Principal Investigator)
  • China Medical University Hospital, Taichung, Taiwan (Recruiting)
    • Ya-Hui Ding
    • Li-Yuan Bai, MD, PhD (Principal Investigator)
  • National Cheng Kung University Hospital, Tainan, Taiwan (Recruiting)
    • Ting-Yu Tseng
    • Chia-Jui Yen, MD (Principal Investigator)
  • Chi Mei Hospital, Tainan, Taiwan (Recruiting)
    • Olivia Chen
    • Chien-Liang Lin, MD (Principal Investigator)
  • National Taiwan University Hospital, Taipei, Taiwan (Recruiting)
    • Jia Ping Jiang
    • Chia-Chi Lin, MD (Principal Investigator)
  • Taipei Veterans General Hospital, Taipei, Taiwan (Recruiting)
    • Chiu-Mei Wang
    • Ming-Huang Chen, MD (Principal Investigator)
  • Mackay Memorial Hospital, Taipei, Taiwan (Recruiting)
    • Chia Jung Lee
    • Nai-Wen Su, MD (Principal Investigator)

Study Officials

  • Study Director (Study Director) — Coherus Oncology