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Tislelizumab

Phase 2

Minimal Residual Disease | Small molecule | Oncology |Takeda Pharmaceutical Company Limited|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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07136077A Phase 2 Trial of Fruquintinib and Tislelizumab in ctDNA-defined Minimal Residual Disease in Colorectal Cancer After Completion of Adjuvant ChemotherapyPHASE2 RECRUITING 20Sep 18, 2025Apr 1, 2028Apr 6, 20261 United States
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Study Endpoints
Primary Endpoints
Safety and adverse events (AEs)
Through study completion; an average of 1 year.

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Phase II: Treatment with Fruquintinib and TislelizumabEXPERIMENTALTreatment with Fruquintinib and Tislelizumab
Interventions
NameTypeDescription
TislelizumabDRUGGiven by IV
FruquintinibDRUGGive by PO
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Eligibility Criteria * Participants must have histologically or cytologically confirmed microsatellite stable (MSS) colorectal adenocarcinoma. * Participants must have completed curative intent treatments of stages II, III, or IV colorectal cancer that must include ≥ 3 months of oxaliplatin contain...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT07136077studyFirstPostDate: changed