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ADG126 Mono

Phase 1

Advanced/Metastatic Solid Tumors | Monoclonal antibody | Oncology |Adagene Inc.|Last Updated: Aug 14, 2024

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 Trials1
Total Enrollment58
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04645069ADG126, ADG126 in Combination With Anti PD1 Antibody, and ADG126 in Combination With ADG106 in Advanced/Metastatic Solid TumorsPHASE1 COMPLETED 58 — — Mar 15, 2021May 17, 2024Aug 14, 20249 United States, Australia +1
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Study Endpoints
Primary Endpoints
Number of participants experiencing dose-limiting toxicities escalating dose levels in adults with advanced / metastatic solid tumors
From first dose of ADG126 (Week 1 Day 1) until 21 days
Number of participants with adverse events as assessed by CTCAE v5.0 ADG126-ADG106 combination regimens
From first dose of ADG126 (Week 1 Day 1) to 90 days post last dose
Secondary Endpoints
Antidrug antibodies (ADAs)
From first dose (Cycle 1 Day 1, ) until the last dose (up to 2 years)
Area under the time concentration curve (AUC) from time zero to infinity (AUC0-inf)
From first dose (Cycle 1 Day 1, ) until the last dose (up to 2 years)
Maximum (peak) plasma concentration (Cmax)
From first dose (Cycle 1 Day 1, ) until the last dose (up to 2 years)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ADG126 mono dose escalationEXPERIMENTALADG126 monotherapy dose escalation will be traditional 3+3 cohort design.
ADG126 mono dose expansionEXPERIMENTALMonotherapy dose expansion is designed to evaluate the preliminary antitumor activity of ADG126 at RP2D or the doses approved by the SRC.
ADG126-anti PD1 drug dose escalationEXPERIMENTALCombination therapy will commence at a dose level lower than the cleared dose from the monotherapy dose escalation arms and approved by the SRC.
ADG126-anti PD1 drug dose expansionEXPERIMENTALCombination therapy expansion will commence at RP2D or the dose approved by the SRC.
ADG126-ADG106 dose escalationEXPERIMENTALCombination therapy will commence at a dose level lower than the cleared dose from the monotherapy dose escalation arms and approved by the SRC.
ADG126-ADG106 dose expansionEXPERIMENTALCombination therapy expansion will commence at RP2D or the dose approved by the SRC.
Interventions
NameTypeDescription
ADG126 MonoBIOLOGICALADG126 will be administered as an IV infusion over 30-60 minutes ± 15 minutes.
ADG126-anti PD1BIOLOGICALADG126-toripalimab combination regimen will receive of toripalimab 15 to 30 minutes after the end of the ADG126 infusion
ADG126-ADG106BIOLOGICALADG126-ADG106 combination regimen will be receive of ADG106 15 to 30 minutes after the end of the ADG126 infusion
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion criteria 1. Adults ≥18 years of age. 2. ECOG performance status 0 or 1. 3. Estimated life expectancy of more than 12 weeks . 4. Patients with advanced or metastatic solid tumors, confirmed by histologically or pathologically documented, who have progressed after all standard therapies, or...

Countries:United StatesAustraliaSingapore
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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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