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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Coherus Oncology, Inc.
Study ID
NCT06657144
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumor
  • Metastatic Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CHS-114 — DRUG
    Solution for infusion
  • Toripalimab — DRUG
    Solution for infusion
  • 5 Fluorouracil — DRUG
    Solution for infusion
  • Cisplatin — DRUG
    Solution for infusion

Study Details

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.

Key Dates

Start date
Apr 1, 2025
Status verified
Apr 2026
Primary completion
Jan 31, 2028
Completion
Jan 31, 2028

Study Design

Enrollment
154 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A - Arm A1: CHS-114 Dose A + Toripalimab
    Participants will be treated with dose A of CHS-114 administered as an intravenous (IV) infusion in combination with toripalimab every 3 weeks (Q3W).
  • Experimental: Cohort A - Arm A2: CHS-114 Dose B + Toripalimab
    Participants will be treated with dose B of CHS-114 administered as an IV infusion in combination with toripalimab Q3W.
  • Experimental: Cohort B - Arm B1: CHS-114 Dose A + Toripalimab
    Participants will be treated with dose A of CHS-114 administered as an IV infusion in combination with toripalimab Q3W.
  • Experimental: Cohort B - Arm B2: CHS-114 Dose B + Toripalimab
    Participants will be treated with dose B of CHS-114 administered as an IV infusion in combination with toripalimab Q3W.
  • Experimental: Cohort C - Arm C: CHS-114 Dose B + Toripalimab + 5 fluorouracil (5 FU) + Cisplatin
    Participants will be treated with dose B of CHS-114 administered as an IV infusion in combination with toripalimab, 5 FU, and cisplatin Q3W.
  • Experimental: Experimental: Cohort D - Arm D1 (Liver Mets): CHS-114 + Toripalimab
    Participants will be treated with CHS-114 administered as an IV infusion in combination with toripalimab Q3W.
  • Experimental: Experimental: Cohort D - Arm D2 (Non-Liver Mets): CHS-114 + Toripalimab
    Participants will be treated with CHS-114 administered as an IV infusion in combination with toripalimab Q3W.

Primary Outcome Measure

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

Central Contacts

Locations (20)

FacilityCityStateZIPSite coordinators
The University of Arizona Cancer CenterTucsonArizona85724-
City of HopeDuarteCalifornia91010
Edwin Smura
[email protected]
626-218-0115
Dani Castillo, MD (PRINCIPAL_INVESTIGATOR)
University of Colorado - Aurora Cancer CenterAuroraColorado80045
Emily Harper
[email protected]
303-724-9407
Sunnie Kim, MD (PRINCIPAL_INVESTIGATOR)
Winship Cancer Center - Emory UniversityAtlantaGeorgia30322
Kathleen Coleman
[email protected]
404-251-1278
Oluwadunni Emiloju, MD (PRINCIPAL_INVESTIGATOR)
Ochsner HealthNew OrleansLouisiana70121
Lauren Roddy
[email protected]
Jonathan Mizrahi, MD (PRINCIPAL_INVESTIGATOR)
Henry Ford Health SystemDetroitMichigan48202
Gazala Khan, MD (PRINCIPAL_INVESTIGATOR)
Comprehensive Cancer Center of NevadaLas VegasNevada89169
AnaArlene Ramirez
[email protected]
702-487-9428
Kyaw Thein, MD (PRINCIPAL_INVESTIGATOR)
Christus St Vincent Regional Medical CenterSanta FeNew Mexico87505
Christopher Gallegos
[email protected]
Andrea Teague, MD (PRINCIPAL_INVESTIGATOR)
START New YorkLake SuccessNew York11042
Sadie Morium
[email protected]
363-207-5166
Geraldine O'Sullivan Coyne, MD (PRINCIPAL_INVESTIGATOR)
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Amin Yaqubie
[email protected]
646-888-4327
Yelena Janjigian, MD (PRINCIPAL_INVESTIGATOR)
Icahn School of Medicine at Mount SinaiNew YorkNew York11766
Joseph Waters
[email protected]
Dan Feng, MD (PRINCIPAL_INVESTIGATOR)
University of Pittsburg Medical Center _UPMC Hillman Cancer CenterPittsburghPennsylvania15232
Nicholas Kerin
[email protected]
412-623-2466
Anwaar Saeed, MD (PRINCIPAL_INVESTIGATOR)
Prisma Health Cancer InstituteGreenvilleSouth Carolina29605
Jill Roemmich
[email protected]
Ki Chung, MD (PRINCIPAL_INVESTIGATOR)
SCRI Oncology PartnersNashvilleTennessee37203
Karlie Williams
[email protected]
Meredith S Pelster, MD (PRINCIPAL_INVESTIGATOR)
Texas Oncology - Central SouthAustinTexas78731
Marian Heaven
[email protected]
Vivian Cline, MD (PRINCIPAL_INVESTIGATOR)
START San Antonio, LLC.San AntonioTexas78229
Isabel Jimenez
[email protected]
210-593-5265
Amita Patnaik, MD (PRINCIPAL_INVESTIGATOR)
Huntsman Cancer Institute, University of UtahSalt Lake CityUtah84112
Jamie White
[email protected]
801-213-6106
Christopher Nevala-Plagemann, MD (PRINCIPAL_INVESTIGATOR)
START Mountain Region, LLC.West Valley CityUtah84119
Marie Asay
[email protected]
801-907-4770
William McKean, MD (PRINCIPAL_INVESTIGATOR)
Virginia Cancer SpecialistsFairfaxVirginia22031
Marcy Sullivan
[email protected]
Mohamad A Salkeni, MD (PRINCIPAL_INVESTIGATOR)
Virginia Oncology AssociatesNorfolkVirginia23502
Amber Ingram
[email protected]
Yue Zhang, MD (PRINCIPAL_INVESTIGATOR)

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