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ADG106

Phase 1

Solid Tumor | Small molecule | Oncology |Adagene Inc.|Trials Updated: Apr 24, 2023

ADG106 development status

Highest phase Phase 1
Registered trials 5 across 3 sponsors since Oct 2018

ADG106 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 Trials2
Total Enrollment111

FDA Designations

No designations recorded

ADG106 clinical trials

ADG106 · 2 trials · 3 indications

Phase 1 2
NCT03802955Study of ADG106 With Advanced or Metastatic Solid Tumors and/or Non-Hodgkin LymphomaSolid Tumor
COMPLETED62 Analytics
NCT03707093Study of CD137 Agonist ADG106 With Advanced or Metastatic Solid Tumors and/or Non-Hodgkin LymphomaSolid Tumors, Non-Hodgkin Lymphoma
COMPLETED49 Analytics
PHASE1COMPLETED
Study of ADG106 With Advanced or Metastatic Solid Tumors and/or Non-Hodgkin Lymphoma
Solid TumorUnlock trial analytics
PHASE1COMPLETED
Study of CD137 Agonist ADG106 With Advanced or Metastatic Solid Tumors and/or Non-Hodgkin Lymphoma
Solid Tumors, Non-Hodgkin LymphomaUnlock trial analytics

Study Endpoints

Primary Endpoints

DLTs in the first 2 cycles of single drug administration
2 Cycles (42 days)
Number of participants experiencing dose-limiting toxicities
2 Cycles (42 days)
Number of participants experiencing clinical and laboratory adverse events (AEs)
First dose to 28 days post last dose

Secondary Endpoints

Number of clinical and laboratory adverse events (AEs) .
First dose to 30 days post last dose
Objective response rate (ORR) as assessed by RECIST version 1.1 and immune-related RECIST (irRECIST) for solid tumor and the Lugano Classification for non-Hodgkin Lymphoma
2 Cycles (42 days)
Duration of response (DOR) as assessed by RECIST version 1.1 and immune-related RECIST (irRECIST) for solid tumor and the Lugano Classification for non-Hodgkin Lymphoma
2 Cycles (42 days)
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ADG106 Dose escalationEXPERIMENTAL -

Interventions

NameTypeDescription
ADG106DRUGIV infusion over 60 minutes on Day 1 of each cycle, at 7 doses depending on cohort at enrollment.
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. Male or female, 18 years to 75 years of age at the time of consent. 2. Provide written informed consent. 3. Subjects with advanced and/or metastatic histologically or cytologically confirmed solid tumor and/or non-Hodgkin lymphoma who are refractory or relapsed from standard ...

Countries:ChinaUnited States
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Competitive Landscape -Other Solid Tumors 10 trials (matched to "Solid Tumor")

Frequently asked questions about ADG106

What is ADG106?

ADG106 is an investigational small molecule developed by Adagene Inc. for advanced or metastatic solid tumors and non-Hodgkin lymphoma. It is designed as a CD137 agonist and has been studied in Phase 1 clinical trials in China and the United States. It is not an approved therapy.

What does ADG106 target?

ADG106 targets CD137, a protein also known as 4-1BB. CD137 is a co-stimulatory receptor on immune cells, and ADG106 is described as a CD137 agonist, meaning it is designed to activate this receptor. The mechanism is intended to stimulate immune responses against tumors.

Who is developing ADG106?

ADG106 is being developed by Adagene Inc., a biotechnology company that trades under the ticker ADAG. Adagene sponsored the Phase 1 studies of ADG106 in advanced or metastatic solid tumors and non-Hodgkin lymphoma.

What phase is ADG106 in?

ADG106 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The completed Phase 1 studies evaluated ADG106 in patients with advanced or metastatic solid tumors and non-Hodgkin lymphoma.

What clinical trials is ADG106 in?

ADG106 has been evaluated in two completed Phase 1 trials. NCT03802955 studied ADG106 in advanced or metastatic solid tumors and non-Hodgkin lymphoma in China with 62 participants. NCT03707093 studied the CD137 agonist ADG106 in the same conditions in the United States with 49 participants.

What is ADG106 used for in solid tumors and non-Hodgkin lymphoma?

ADG106 is being studied for the treatment of advanced or metastatic solid tumors and non-Hodgkin lymphoma. Both completed Phase 1 trials enrolled adults aged 18 years and older with these conditions. It remains an investigational agent and is not approved for any use.