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ADG116

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
CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment78
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05277402ADG116 in Combination With Pembrolizumab in Patients With Advanced/Metastatic Solid TumorsPHASE1 COMPLETED 6Feb 9, 2022Dec 1, 2022Feb 26, 20242 United States
NCT04501276A Phase 1b/2 Study of ADG116, ADG116 Combined With Anti-PD-1 Antibody or Anti-CD137 Antibody in Solid Tumors PatientsPHASE1 COMPLETED 72Sep 23, 2020Nov 30, 2025Jan 8, 20264 United States, Australia
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Study Endpoints
Primary Endpoints
Dose-limiting toxicity (DLT) and RP2D of ADG116 in combination with pembrolizumab.
9 months

Number of participants experiencing dose-limiting toxicities escalating dose levels in adults with advanced / metastatic solid tumor

The safety and tolerability of ADG116 in combination with pembrolizumab
9 month

Number of participants with adverse events as assessed by CTCAE v5.0

Number of participants experiencing dose-limiting toxicities escalating dose levels in adults with advanced / metastatic solid tumors
From first dose of ADG116 (Week 1 Day 1) until 21 days
Number of participants with adverse events as assessed by CTCAE v5.0
From first dose of ADG116 (Week 1 Day 1) to 28 days post last dose
Secondary Endpoints
Pharmacokinetic (PK) profile/parameters
9 Months
Maximum (peak) plasma concentration (Cmax)
9 months
Time to maximum (peak) concentration (Tmax)
9 month
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Dose escalationEXPERIMENTALADG116 combination treatment with pembrolizumab (KEYTRUDA®), both drugs will be administered in each cohort.
Part A : Dose escalation of ADG116 monotherapyEXPERIMENTAL -
Part B : Dose escalation of ADG116 combined with anti PD1 drugEXPERIMENTAL -
Part C : Dose escalation of ADG116 combined with ADG106EXPERIMENTAL -
Interventions
NameTypeDescription
ADG116DRUGIV infusion
ADG106DRUGFor the ADG116-ADG106 combination regimen, ADG116 and ADG106 will be administered until disease progression, intolerable toxicities, or withdrawal of consent, or up to 2 years.
anti PD1 drugDRUGFor the ADG116-anti PD1 combination regimen, ADG116 and anti PD1 will be administered 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: * Patients must meet all of the following inclusion criteria to be eligible for participation in this study: 1. ≥ 18 years of age at the time of informed consent. 2. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 with no deterioration over the previous ...

Countries:United StatesAustralia
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