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ADG106

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment62

FDA Designations

No designations recorded

Clinical trial landscape

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 9 trials (matched to "Solid Tumor")

Frequently asked questions about ADG106

What is ADG106 used for?

ADG106 is an investigational small molecule being studied for the treatment of advanced or metastatic solid tumors and non-Hodgkin lymphoma. It is in Phase 1 clinical development and has not been approved by regulatory authorities.

Who is developing ADG106?

ADG106 is being developed by Adagene Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ADAG. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational oncology drug.

What phase is ADG106 in?

ADG106 is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval and is still being studied in clinical trials to assess its safety and potential efficacy in patients.

What clinical trials is ADG106 in?

ADG106 has been studied in two completed Phase 1 clinical trials. One trial, NCT03707093, was conducted in the United States and enrolled 49 patients with solid tumors or non-Hodgkin lymphoma. The other, NCT03802955, was conducted in China and enrolled 62 patients with the same conditions.

Is ADG106 the same as a CD137 agonist?

ADG106 is described as a CD137 agonist in the title of one of its clinical trials, NCT03707093. This indicates that the drug is designed to target and activate the CD137 receptor, which is involved in immune response regulation.