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HEC169096

Phase 1

Advanced Solid Tumor | Small molecule | Oncology |Sunshine Biopharma Inc.|Last Updated: Apr 28, 2026

Success Probability
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Market & Valuation
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment456
FDA Designations
No designations recorded
Clinical trial landscape

HEC169096 · 1 trial · 1 indication

Phase 1 1
NCT05451602HEC169096 in Participants With Advanced Solid TumorsAdvanced Solid Tumor
RECRUITING456 Analytics
PHASE1RECRUITING
HEC169096 in Participants With Advanced Solid Tumors
Advanced Solid Tumor
NCT05451602456
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Study Endpoints
Primary Endpoints
Phase 1: MTD and RP2D of HEC169096
Cycle 1 (28 days) of treatment for MTD and at the end of every 2 cycle for RP2D for approximately 12 months or earlier if participant terminates from the study

Determination of Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of HEC169096

Phase 2: Overall Response Rate
through study completion, an average of 1 year

As assessed by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)

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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
HEC169096EXPERIMENTALMultiple doses of HEC169096
Interventions
NameTypeDescription
HEC169096DRUGMultiple doses of HEC169096 during Phase 2；Oral dose of HEC169096 as determined during Phase 2.
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Phase 1：Pathologically documented, definitively diagnosed non-resectable advanced solid tumor. * Phase 2： All participants must have an oncogenic RET-rearrangement/fusion or mutation (excluding synonymous, frameshift, and nonsense mutations) solid tumor. * Participants has Eas...

Countries:China
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced Solid Tumor")
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
AstraZeneca PLCAZN1 - Trastuzumab deruxtecan
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Recent Changes (Last 90 Days)
LOWJul 5, 2026NCT05451602primaryCompletionDate: changed
LOWJul 5, 2026NCT05451602primaryCompletionDate: changed
LOWJul 5, 2026NCT05451602primaryCompletionDate: changed
LOWMay 24, 2026NCT05451602studyFirstPostDate: changed