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ADG206

Phase 1

Advanced/Metastatic Solid Tumors | Small molecule | Oncology |Adagene Inc.|Last Updated: Jan 8, 2026

Target and mechanism

Molecular targetCD137
Target classProtein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment14

FDA Designations

No designations recorded

Clinical trial landscape

ADG206 · 1 trial · 1 indication

Phase 1 1
NCT05614258Study of ADG206 in Subjects With Advanced/Metastatic Solid TumorsAdvanced/Metastatic Solid Tumors
ACTIVE NOT_RECRUITING14 Analytics
PHASE1ACTIVE NOT_RECRUITING
Study of ADG206 in Subjects With Advanced/Metastatic Solid Tumors
Advanced/Metastatic Solid TumorsUnlock trial analytics

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 to 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 (matched to "Advanced/Metastatic Solid Tumors")

Recent Changes (Last 90 Days)

LOWMay 26, 2026NCT05614258primaryCompletionDate: changed
LOWMay 24, 2026NCT05614258studyFirstPostDate: changed

Frequently asked questions about ADG206

What is ADG206 used for?

ADG206 is an investigational small molecule being developed for the treatment of advanced or metastatic solid tumors. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied in patients with advanced or metastatic solid tumors who are at least 18 years old.

What does ADG206 target?

ADG206 targets CD137, a protein involved in immune response. By targeting CD137, ADG206 is designed to modulate the immune system's activity against cancer cells. This mechanism is being evaluated in the context of advanced or metastatic solid tumors, where the drug aims to enhance the body's ability to fight the disease.

Who is developing ADG206?

ADG206 is being developed by Adagene Inc., a biopharmaceutical company listed on the stock exchange under the ticker symbol ADAG. The company is conducting clinical trials to evaluate the safety and efficacy of ADG206 in patients with advanced or metastatic solid tumors.

What phase is ADG206 in?

ADG206 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 1 trial is designed to assess the safety, tolerability, and preliminary efficacy of ADG206 in patients with advanced or metastatic solid tumors.

What clinical trials is ADG206 in?

ADG206 is being studied in a Phase 1 clinical trial with the identifier NCT05614258. The trial, titled "Study of ADG206 in Subjects With Advanced/Metastatic Solid Tumors," is active but not recruiting participants. It is enrolling patients in Australia and has a target enrollment of 14 participants.

Is ADG206 the same as other CD137-targeting drugs?

ADG206 is a distinct investigational small molecule that targets CD137. While other drugs may also target CD137, ADG206 is a unique asset developed by Adagene Inc. Its specific chemical structure and properties differentiate it from other CD137-targeting agents, and it is being evaluated independently in clinical trials.