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ADG126 in Combination With Pembrolizumab in Patients With Advanced/Metastatic Solid Tumors

← catalyst calendar

NCT05405595 · readout in 72 d

Sponsored by Adagene Inc (industry) · ADAG — their whole pipeline →. With Merck Sharp & Dohme LLC.

Phase
Phase 1/2
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
186estimated
Sites
21
Countries
China, South Korea, United States

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2022-06-15actualWhen the study began enrolling
Primary completion2026-10-31estimatedThe date the last participant is measured for the primary outcome — the readout window
Study completion2027-04-30estimatedThe whole study's end, after follow-up
First posted2022-06-06actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-01-07actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

  • Advanced/Metastatic Solid Tumors

Interventions

  • Drug: ADG126
  • Drug: Pembrolizumab (KEYTRUDA®) — also filed as KEYTRUDA®
  • Drug: Standard of Care (Trifluridine/Tipiracil-Bevacizumab) — also filed as Lonsurf and Avastin
  • Drug: Standard of care (Fruquintinib) — also filed as Fruzaqla

Primary outcomes

what the primary-completion date above is the date OF
Maximum tolerated dose (MTD) and RP2D for ADG126 in combination with pembrolizumab.
measured 9 months
the safety and tolerability of ADG126 at escalating dose level in combination with pembrolizumab in adults with advanced metastatic solid tumors
measured 9 months
Access the preliminary antitumor activity of ADG126-pembrolizumab combination regimens
measured 9 months
Maximum tolerated dose (MTD) and/or RP2D for ADG126 with Trifluridine/Tipiracil-Bevacizumab
measured 6 months
Access the preliminary antitumor activity of ADG126 with Pembrolizumab in combination standard of care
measured 6 months
Access and characterize the optimal dose based on safety and efficacy parameters
measured 9 months

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