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CHS-1000

Phase 1

Advanced or Metastatic Solid Tumors | Monoclonal antibody | Oncology |Coherus Oncology, Inc.|Last Updated: Sep 19, 2024

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
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment48
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06389526A Study of CHS-1000 in Participants With Advanced or Metastatic Solid TumorsPHASE1 NOT YET_RECRUITING 48Feb 15, 2025May 30, 2028Sep 19, 2024 -
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Study Endpoints
Primary Endpoints
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Up to approximately 27 months
Secondary Endpoints
Maximum Observed Concentration (Cmax)
Up to approximately 27 months
Area Under the Concentration-time Curve (AUC)
Up to approximately 27 months
Terminal Half-life (t1/2)
Up to approximately 27 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part A: Single Agent CHS-1000EXPERIMENTAL -
Part B: Combination Agents CHS-1000 + ToripalimabEXPERIMENTAL -
Interventions
NameTypeDescription
CHS-1000BIOLOGICALSpecified dose on specified days
ToripalimabBIOLOGICALSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Key Inclusion Criteria: * Histopathologically or cytologically confirmed diagnosis of advanced or metastatic unresectable solid tumors (excluding glioblastoma multiforme (GBM)) by tissue biopsy or archival tumor specimen. Unresectable tumors are defined as tumors with lesions in which clear surgica...

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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06389526primaryCompletionDate: changed
LOWMay 24, 2026NCT06389526studyFirstPostDate: changed