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ADG126 Mono

Phase 1

Advanced/Metastatic Solid Tumors | Monoclonal antibody | Oncology |Adagene Inc.|Last Updated: Aug 14, 2024

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment58

FDA Designations

No designations recorded

Clinical trial landscape

ADG126 Mono · 1 trial · 1 indication

Phase 1 1
NCT04645069ADG126, ADG126 in Combination With Anti PD1 Antibody, and ADG126 in Combination With ADG106 in Advanced/Metastatic Solid TumorsAdvanced/Metastatic Solid Tumors
COMPLETED58 Analytics
PHASE1COMPLETED
ADG126, ADG126 in Combination With Anti PD1 Antibody, and ADG126 in Combination With ADG106 in Advanced/Metastatic Solid Tumors
Advanced/Metastatic Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants experiencing dose-limiting toxicities escalating dose levels in adults with advanced / metastatic solid tumors
From first dose of ADG126 (Week 1 Day 1) until 21 days
Number of participants with adverse events as assessed by CTCAE v5.0 ADG126-ADG106 combination regimens
From first dose of ADG126 (Week 1 Day 1) to 90 days post last dose

Secondary Endpoints

Antidrug antibodies (ADAs)
From first dose (Cycle 1 Day 1, ) until the last dose (up to 2 years)
Area under the time concentration curve (AUC) from time zero to infinity (AUC0-inf)
From first dose (Cycle 1 Day 1, ) until the last dose (up to 2 years)
Maximum (peak) plasma concentration (Cmax)
From first dose (Cycle 1 Day 1, ) until the last dose (up to 2 years)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ADG126 mono dose escalationEXPERIMENTALADG126 monotherapy dose escalation will be traditional 3+3 cohort design.
ADG126 mono dose expansionEXPERIMENTALMonotherapy dose expansion is designed to evaluate the preliminary antitumor activity of ADG126 at RP2D or the doses approved by the SRC.
ADG126-anti PD1 drug dose escalationEXPERIMENTALCombination therapy will commence at a dose level lower than the cleared dose from the monotherapy dose escalation arms and approved by the SRC.
ADG126-anti PD1 drug dose expansionEXPERIMENTALCombination therapy expansion will commence at RP2D or the dose approved by the SRC.
ADG126-ADG106 dose escalationEXPERIMENTALCombination therapy will commence at a dose level lower than the cleared dose from the monotherapy dose escalation arms and approved by the SRC.
ADG126-ADG106 dose expansionEXPERIMENTALCombination therapy expansion will commence at RP2D or the dose approved by the SRC.

Interventions

NameTypeDescription
ADG126 MonoBIOLOGICALADG126 will be administered as an IV infusion over 30-60 minutes ± 15 minutes.
ADG126-anti PD1BIOLOGICALADG126-toripalimab combination regimen will receive of toripalimab 15 to 30 minutes after the end of the ADG126 infusion
ADG126-ADG106BIOLOGICALADG126-ADG106 combination regimen will be receive of ADG106 15 to 30 minutes after the end of the ADG126 infusion
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion criteria 1. Adults ≥18 years of age. 2. ECOG performance status 0 or 1. 3. Estimated life expectancy of more than 12 weeks . 4. Patients with advanced or metastatic solid tumors, confirmed by histologically or pathologically documented, who have progressed after all standard therapies, or...

Countries:United StatesAustraliaSingapore
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced/Metastatic Solid Tumors")

Frequently asked questions about ADG126 Mono

What is ADG126 Mono used for?

ADG126 Mono is an investigational monoclonal antibody being studied 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 evaluated as a monotherapy and in combination with other agents in patients with advanced solid tumors.

Who makes ADG126 Mono?

ADG126 Mono is being developed by Adagene Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol ADAG. Adagene is conducting clinical trials to evaluate the safety and efficacy of ADG126 Mono in patients with advanced or metastatic solid tumors.

What phase is ADG126 Mono in?

ADG126 Mono is in Phase 1 clinical development. It is an investigational drug and has not yet received regulatory approval. The Phase 1 trial has been completed, and the drug remains under investigation for the treatment of advanced or metastatic solid tumors.

What clinical trials is ADG126 Mono in?

ADG126 Mono was studied in a Phase 1 clinical trial with the identifier NCT04645069. This trial evaluated ADG126 as a monotherapy, in combination with an anti-PD1 antibody, and in combination with ADG106 in patients with advanced or metastatic solid tumors. The trial enrolled 58 participants and was conducted in the United States, Australia, and Singapore.

Is ADG126 Mono the same as ADG126?

ADG126 Mono refers to the use of ADG126 as a single agent, as opposed to its use in combination with other therapies. In clinical trials, ADG126 is studied both as a monotherapy and in combination with other drugs, such as an anti-PD1 antibody or ADG106.