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Study of ADG206 in Subjects With Advanced/Metastatic Solid Tumors
ADG206 is an activatable prodrug form of a fully human monoclonal antibody (mAb) of the immunoglobulin G1 (IgG1) subclass that specifically targets cluster of differentiation 137 (CD137) (also known as 4-1BB) as a co-stimulatory receptor agonist for the treatment of advanced malignancies.
Study details:
This is a FIH, Phase 1, open-label, multicenter, sequential dose escalation study to evaluate the safety, tolerability, Pharmacokinetics (PK), and preliminary efficacy of ADG206 in subjects with advanced/metastatic malignancies. Primary Objective of the study: To assess safety and tolerability at increasing dose levels of ADG206 in subjects with advanced/metastatic solid tumors who have exhausted their treatment alternatives.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-02-13
Primary completion: 2025-05-01
Study completion finish: 2025-10-01
Study type
TREATMENT
Phase
PHASE1
Trial ID
NCT05614258
Intervention or treatment
DRUG: ADG206
Conditions
- • Advanced/Metastatic Solid Tumors
Find a site
Closest Location:
Monash Health
Research sites nearby
Select from list below to view details:
Monash Health
Clayton, Victoria, Australia
Ashford Cancer Centre Research
Kurralta Park, South Australia, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: ADG206 dose escalation
| DRUG: ADG206
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Number of participants experiencing dose-limiting toxicities escalating dose levels | Not Specified | At the end of Cycle 1 (each cycle is 21 days) |
Number of participants with adverse events (AE) | Not Specified | At the end of 90 days post last dose (each cycle is 21 days) |
Maximum administered dose (MAD) of ADG206 | Not Specified | At the end of the last dose (each cycle is 21 days) |
Maximum tolerated dose (MTD) of ADG 206 | Not Specified | At the end of the last dose (each cycle is 21 days) |
Recommended Phase 2 dose (RP2D) of ADG206 | Not Specified | At the end of the last dose (each cycle is 21 days) |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
The area under the curve (AUC) of plasma concentration of drug | Not Specified | At the end of the last dose (each cycle is 21 days) |
Immunogenicity endpoints include antidrug antibodies (ADAs) | Not Specified | At the end of the last dose (each cycle is 21 days) |
Maximum concentration (Cmax) | Not Specified | At the end of the last dose (each cycle is 21 days) |
Time to maximum plasma concentration (Tmax) | Not Specified | At the end of the last dose (each cycle is 21 days) |
Lowest plasma concentration (C[trough]) | Not Specified | At the end of the last dose (each cycle is 21 days) |
Frequently Asked Questions
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