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ADG126

Phase 2

Locally Advanced Colorectal Cancer | 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06846268Neoadjuvant ADG126 and Pembrolizumab in Locally Advanced Colorectal CancerPHASE2 RECRUITING 20Apr 14, 2025Dec 31, 2027Jul 25, 20251 Singapore
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Study Endpoints
Primary Endpoints
Rate of Major Pathologic Response (MPR)
Up to 4 months

MPR is defined as less than or equal to 10% of residual viable tumour in the surgical specimen.

Secondary Endpoints
Rate of Pathologic Complete Response (pCR)
Up to 4 months.
Objective Response Rate (ORR)
Up to 4 months.
Disease-free survival (DFS)
Up to 5 years from surgery.
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ADG126 in combination with pembrolizumabEXPERIMENTALADG 126 will be administered with Pembrolizumab on Day 1 and Day 22 or Pembrolizumab on Day 22 alone depending on the dose level.
Interventions
NameTypeDescription
ADG126DRUGAdministered via intravenous infusion on Day 1 only (Q6W) or Day 1 and Day 22 (Q3W).
PembrolizumabDRUGAdministered via intravenous infusion on Day 1 and Day 22.
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Eligibility Criteria
Age Range21 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Willing and able to provide written informed consent for the trial. 2. Be ≥ 21 years of age on the date of signing informed consent. 3. ECOG performance status of 0 or 1. 4. Histologically confirmed colorectal adenocarcinoma. Rectal cancers allowed if the treatment plan was u...

Countries:Singapore
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06846268primaryCompletionDate: changed
LOWMay 24, 2026NCT06846268studyFirstPostDate: changed