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Pembrolizumab & ADG106

Phase 1

Advanced Solid Tumor | Small molecule | Oncology |Adagene Inc.|Last Updated: Jul 25, 2025

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 Enrollment51
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05491083Pembrolizumab and ADG106 in Advanced Solid Cancers and Triple Negative Breast CancerPHASE1 RECRUITING 51Jun 12, 2023Dec 31, 2026Jul 25, 20251 Singapore
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Study Endpoints
Primary Endpoints
Number of participant with treatment related toxicities (Phase Ib)
3 years

Toxicities will be graded using the Common Terminology Criteria for Adverse Events (CTCAE) toxicity grading Version 5

Objective response rate (ORR) in Phase II
3 years

Complete and partial clinical response will be measured by RECIST 1.1.

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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Phase 1b Pembrolizumab & ADG106EXPERIMENTALIntravenous Pembrolizumab + ADG106 on day 1 of each 3-weekly cycle
Phase 2 Pembrolizumab & ADG106EXPERIMENTALIntravenous Pembrolizumab + ADG106 each 3-weekly cycle
Interventions
NameTypeDescription
Pembrolizumab & ADG106 (Phase Ib)DRUGDrug: ADG106 Administered as an intravenous infusion over 60-90 minutes in the initial cycle and over 30 minutes in subsequent cycle if well tolerated. Pembrolizumab Administered as an intravenous infusion over 30 minutes
Pembrolizumab & ADG106 (Phase II)DRUGDrug: ADG106 Administered as an intravenous infusion over 60-90 minutes in the initial cycle and over 30 minutes in subsequent cycle if well tolerated. Pembrolizumab Administered as an intravenous infusion over 30 minutes
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Eligibility Criteria
Age Range21 Years — 99 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * 21 years and above of age * Estimated life expectancy of at least 12 weeks. * Has recovered from acute toxicities from prior anti-cancer therapies. * Has a tumor lesion that can be safely biopsied and who is willing to undergo tumor biopsy at baseline before starting study tre...

Countries:Singapore
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05491083primaryCompletionDate: changed
LOWMay 24, 2026NCT05491083studyFirstPostDate: changed