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ATRA

Phase 1

Advanced Pancreatic Ductal Adenocarcinoma | Small molecule | Oncology |BeOne Medicines Ltd.|Last Updated: Jan 16, 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 Enrollment10
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07348107ATRA and SDK002 in Combination With Chemotherapy and Anti-PD-1 Inhibitor in Patients With Advanced Pancreatic Ductal Adenocarcinoma.PHASE1 NOT YET_RECRUITING 10Feb 15, 2026Mar 1, 2027Jan 16, 20261 Canada
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Study Endpoints
Primary Endpoints
Number of Participants with Adverse Events as Assessed by CTCAE v5.0
Up to 6 months.

Safety will be evaluated by the incidence of adverse events (AEs), including serious adverse events (SAEs), grade 3 and 4 adverse events, adverse events of all grades, and adverse events leading to the discontinuation of study medication. Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Safety outcomes will be analyzed using descriptive analyses, including the number and percentage of participants with AEs, SAEs, deaths, adverse events leading to treatment discontinuation, and adverse events by severity and relatedness. Adverse events will be summarized by system organ class and preferred term using the Medical Dictionary for Regulatory Activities (MedDRA). Clinically significant changes in vital signs and clinical laboratory results will be summarized descriptively, and shift tables will be provided showing change in CTCAE grade from baseline to worst post-baseline grade.

Secondary Endpoints
6-Month Progression-Free Survival Rate
6 months.
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TreatmentEXPERIMENTALATRA - 45mg/m2, oral, daily SDK002 - 10mg, oral, daily Gemcitabine - 800mg/m2, IV, Days 1, 8, 15 of a 28 day cycle Nab-paclitaxel - 125mg/m2, IV, Days 1, 8, 15 of a 28 day cycle Tislelizumab - 300mg, IV, Day 1 of a 28 day cycle
Interventions
NameTypeDescription
ATRADRUGOrally administered all-trans retinoic acid (ATRA) for up to 6 cycles in combination with chemotherapy and immunotherapy.
Arsenic Trioxide (ATO)DRUGOrally administered SDK002 for up to 6 cycles in combination with chemotherapy and immunotherapy.
GemcitabineDRUGStandard intravenous chemotherapy, administered per protocol.
Nab-paclitaxelDRUGStandard intravenous chemotherapy, administered per protocol.
TislelizumabDRUGAnti-PD-1 immune checkpoint inhibitor, administered intravenously for up to 26 cycles.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria * Participants must have previously untreated unresectable/ metastatic PDAC, without plans for a curative surgery, previous neoadjuvant therapy with 5-FU based therapy is permitted but neoadjuvant gemcitabine-based therapy must have been completed at least 6-months prior to enrol...

Countries:Canada
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT07348107studyFirstPostDate: changed