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ADG206

Phase 1

Advanced/Metastatic Solid Tumors | Small molecule | Oncology |Adagene Inc.|Last Updated: Jan 8, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment14
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05614258Study of ADG206 in Subjects With Advanced/Metastatic Solid TumorsPHASE1 ACTIVE NOT_RECRUITING 14 — — Feb 13, 2023Aug 30, 2026Jan 8, 20262 Australia
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Study Endpoints
Primary Endpoints
Number of participants experiencing dose-limiting toxicities escalating dose levels
At the end of Cycle 1 (each cycle is 21 days)
Number of participants with adverse events (AE)
At the end of 90 days post last dose (each cycle is 21 days)
Maximum administered dose (MAD) of ADG206
At the end of the last dose (each cycle is 21 days)
Maximum tolerated dose (MTD) of ADG 206
At the end of the last dose (each cycle is 21 days)
Recommended Phase 2 dose (RP2D) of ADG206
At the end of the last dose (each cycle is 21 days)
Secondary Endpoints
The area under the curve (AUC) of plasma concentration of drug
At the end of the last dose (each cycle is 21 days)
Immunogenicity endpoints include antidrug antibodies (ADAs)
At the end of the last dose (each cycle is 21 days)
Maximum concentration (Cmax)
At the end of the last dose (each cycle is 21 days)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ADG206 dose escalationEXPERIMENTAL -
Interventions
NameTypeDescription
ADG206DRUGAll participants in this study will receive the study drug ADG206 in one of the designed dosage level. ADG206 will be administered by intravenous infusion over 60-90 minutes on Day 1 of each treatment cycle until disease progression, intolerable toxicities or withdrawal of consent, or up to 2 years.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status ≤1. * Subjects with advanced or metastatic solid tumors (except thymic tumors), which have progressed after all standard therapies, or no further standard therapies exists. * At least 1 measurable lesion per Response...

Countries:Australia
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Competitive Landscape -Other Solid Tumors 9 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab, V503, GARDASIL
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
AstraZeneca PLCAZN1 — Trastuzumab deruxtecan
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05614258primaryCompletionDate: changed
LOWMay 24, 2026NCT05614258studyFirstPostDate: changed