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Tislelizumab

Phase 3

Advanced Malignancies | Small molecule | Other |BeOne Medicines Ltd.|Last Updated: Jun 3, 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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment404
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04164199Study of Tislelizumab, Pamiparib, and Other Investigational Agents in Participants With Advanced MalignanciesPHASE3 COMPLETED 404Dec 19, 2019May 23, 2026Jun 3, 2026106 United States, Australia +11
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Study Endpoints
Primary Endpoints
Number of Participants with Immune-Mediated Adverse Events, Serious Adverse Events, and Adverse Events Grade 3 or Higher
up to 7 years

Safety as assessed by the number of participants with immune-mediated adverse events (imAEs), ≥ Grade 3 adverse events, and serious adverse events.

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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
A - Tislelizumab MonotherapyEXPERIMENTAL -
B - Pamiparib MonotherapyEXPERIMENTAL -
C - Sitravatinib MonotherapyEXPERIMENTAL -
D - BGB-15025 MonotherapyEXPERIMENTAL -
E - Zanidatamab MonotherapyEXPERIMENTAL -
F - Pamiparib and Temozolomide Combination TherapyEXPERIMENTAL -
G - Tislelizumab and Pamiparib Combination TherapyEXPERIMENTAL -
H - Tislelizumab and Sitravatinib Combination TherapyEXPERIMENTAL -
I - Tislelizumab and Ociperlimab Combination TherapyEXPERIMENTAL -
J - Tislelizumab and BAT1706 Combination Therapy, or BAT1706 MonotherapyEXPERIMENTAL -
K - Tislelizumab and Fruquintinib Combination TherapyEXPERIMENTAL -
L - Tislelizumab and BGB-A445 Combination TherapyEXPERIMENTAL -
M - Tislelizumab and Surzebiclimab Combination TherapyEXPERIMENTAL -
N - Tislelizumab and BGB-15025 Combination TherapyEXPERIMENTAL -
O - Tislelizumab and Lenvatinib Combination TherapyEXPERIMENTAL -
P - Tislelizumab and Zanidatamab Combination TherapyEXPERIMENTAL -
Q - Tislelizumab and LBL-007 Combination TherapyEXPERIMENTAL -
R - Tislelizumab and Surzebiclimab and LBL-007 Combination TherapyEXPERIMENTAL -
Interventions
NameTypeDescription
TislelizumabDRUGAdministered intravenously.
PamiparibDRUGAdministered orally.
TemozolomideDRUGAdministered orally.
SitravatinibDRUGAdministered orally.
OciperlimabDRUGAdministered intravenously.
BAT1706DRUGAdministered intravenously.
FruquintinibDRUGAdministered orally.
BGB-15025DRUGAdministered orally.
ZanidatamabDRUGAdministered intravenously.
BGB-A445DRUGAdministered intravenously.
SurzebiclimabDRUGAdministered intravenously.
LenvatinibDRUGAdministered orally.
LBL-007DRUGAdministered intravenously.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites106

Key Inclusion Criteria: 1. Currently participating in a BeiGene- or BeOne-sponsored eligible parent study 2. Fulfills treatment criteria specified in the parent study protocol 3. In the opinion of the investigator, the participant will continue to benefit from and tolerate any of the parent study t...

Countries:United StatesAustraliaChinaFranceItalyJapanMalaysiaNew ZealandPolandSouth KoreaTaiwanThailandTurkey (Türkiye)
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Recent Changes (Last 90 Days)
HIGHJun 3, 2026NCT04164199Status: ACTIVE_NOT_RECRUITING → COMPLETED
HIGHJun 3, 2026NCT04164199Status: ACTIVE_NOT_RECRUITING → COMPLETED
MEDIUMMay 26, 2026NCT04164199Status: ENROLLING_BY_INVITATION → ACTIVE_NOT_RECRUITING
LOWMay 24, 2026NCT04164199studyFirstPostDate: changed