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Quemliclustat

Phase 3

Metastatic Pancreatic Ductal Adenocarcinoma | Small molecule | Oncology |Arcus Biosciences, Inc.|Last Updated: Jun 2, 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
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment610
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06608927Study of Quemliclustat and Chemotherapy Versus Placebo and Chemotherapy in Patients With Metastatic Pancreatic Ductal AdenocarcinomaPHASE3 ACTIVE NOT_RECRUITING 610Dec 13, 2024Nov 30, 2030Jun 2, 2026111 United States, Australia +11
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Study Endpoints
Primary Endpoints
Overall Survival (OS)
Up to 72 months
Secondary Endpoints
Progression-free Survival (PFS) as determined by the Investigator according to RECIST v1.1
Up to 72 months
Objective response rate (ORR) as determined by the Investigator according to RECIST v1.1
Up to 72 months
Duration of response (DoR) as determined by the Investigator according to RECIST v1.1
Up to 72 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm A (Experimental Arm)EXPERIMENTALQuemliclustat, nab-paclitaxel and gemcitabine will be administered by IV infusion
Arm B (Comparator Arm)PLACEBO_COMPARATORPlacebo, nab-paclitaxel and gemcitabine will be administered by IV infusion
Interventions
NameTypeDescription
QuemliclustatDRUGAdministered as specified in the treatment arm
PlaceboDRUGAdministered as specified in the treatment arm
Nab-paclitaxelDRUGAdministered as specified in the treatment arm
GemcitabineDRUGAdministered as specified in the treatment arm
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites111

Inclusion Criteria: * Have histologically or cytologically confirmed PDAC that is metastatic. * Have not been previously treated for PDAC in the metastatic setting. 1. Prior neoadjuvant and/or adjuvant therapy for PDAC is permitted if completed at least 12 months before randomization. 2. Prior...

Countries:United StatesAustraliaAustriaBelgiumCanadaCzechiaFranceGermanyItalyJapanSouth KoreaSpainUnited Kingdom
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Recent Changes (Last 90 Days)
LOWJun 2, 2026NCT06608927lastUpdatePostDate: changed
LOWJun 2, 2026NCT06608927lastUpdatePostDate: changed
LOWJun 2, 2026NCT06608927lastUpdatePostDate: changed
LOWMay 26, 2026NCT06608927primaryCompletionDate: changed
LOWMay 24, 2026NCT06608927studyFirstPostDate: changed