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CHS-114

Phase 1

Metastatic Solid Tumor | Small molecule | Oncology |Coherus Oncology, Inc.|Last Updated: Apr 6, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment154
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06657144A Study of CHS-114 (Tagmokitug) in Combination With Toripalimab and/or Other Treatments in Participants With Advanced Solid TumorsPHASE1 RECRUITING 154Apr 1, 2025Jan 1, 2028Apr 6, 202630 United States, Taiwan
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Study Endpoints
Primary Endpoints
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)
Secondary Endpoints
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Based on Investigator Assessment
Up to approximately 2.25 years
Duration of Response (DOR) Per RECIST v1.1 Based on Investigator Assessment
Up to approximately 2.25 years
Disease Control Rate (DCR) Per RECIST v1.1 Based on Investigator Assessment
Up to approximately 2.25 years
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort A - Arm A1: CHS-114 Dose A + ToripalimabEXPERIMENTALParticipants will be treated with dose A of CHS-114 administered as an intravenous (IV) infusion in combination with toripalimab every 3 weeks (Q3W).
Cohort A - Arm A2: CHS-114 Dose B + ToripalimabEXPERIMENTALParticipants will be treated with dose B of CHS-114 administered as an IV infusion in combination with toripalimab Q3W.
Cohort B - Arm B1: CHS-114 Dose A + ToripalimabEXPERIMENTALParticipants will be treated with dose A of CHS-114 administered as an IV infusion in combination with toripalimab Q3W.
Cohort B - Arm B2: CHS-114 Dose B + ToripalimabEXPERIMENTALParticipants will be treated with dose B of CHS-114 administered as an IV infusion in combination with toripalimab Q3W.
Cohort C - Arm C: CHS-114 Dose B + Toripalimab + 5 fluorouracil (5 FU) + CisplatinEXPERIMENTALParticipants will be treated with dose B of CHS-114 administered as an IV infusion in combination with toripalimab, 5 FU, and cisplatin Q3W.
Experimental: Cohort D - Arm D1 (Liver Mets): CHS-114 + ToripalimabEXPERIMENTALParticipants will be treated with CHS-114 administered as an IV infusion in combination with toripalimab Q3W.
Experimental: Cohort D - Arm D2 (Non-Liver Mets): CHS-114 + ToripalimabEXPERIMENTALParticipants will be treated with CHS-114 administered as an IV infusion in combination with toripalimab Q3W.
Interventions
NameTypeDescription
CHS-114DRUGSolution for infusion
ToripalimabDRUGSolution for infusion
5 FluorouracilDRUGSolution for infusion
CisplatinDRUGSolution for infusion
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites30

Key Inclusion 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...

Countries:United StatesTaiwan
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT06657144primaryCompletionDate: changed
LOWMay 24, 2026NCT06657144studyFirstPostDate: changed