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
- 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 Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
- Adequate organ function.
- Woman of childbearing potential must agree to use 2 methods of acceptable contraception from screening until 6 months after the last dose of study drug.
- Male subjects who are sexually active with a female partner of childbearing potential must agree to use a barrier contraception.
Exclusion criteria
- Subjects within washout period of other anti-tumor therapies.
- History of prior malignancy other than the cancer under treatment in the study.
- Major trauma or major surgery within 4 weeks before the first dose of study drug.
- Serious nonhealing wound, ulcer, or bone fracture.
- History of significant immune-mediated AE.
- Central nervous system (CNS) disease involvement.
- Any evidence of underlying severe liver dysfunction.
- Prior organ allograft transplantations or allogeneic bone marrow, cord blood or peripheral blood stem cell transplantation.
- Clinically significant cardiac disease with insufficient cardiac function.
- Evidence of active uncontrolled viral, bacterial, or systemic fungal infection.
- Known positive test result for human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS).
- Infection of hepatitis B virus (HBV), or hepatitis C virus (HCV) (unless the disease is clinically controlled).
- History or risk of autoimmune disease.
- Subjects with active severe lung infection or with a history of interstitial lung diseases, noninfectious pneumonitis, active pulmonary tuberculosis, or evidence of active pneumonitis.
- Clinically significant and unmanageable ascites defined as requiring constant therapeutic paracentesis.
- Any serious underlying issue that would limit compliance with study requirements, impair the ability of the subject to understand informed consent.
- Known hypersensitivity, allergies, or intolerance to immunoglobulins or to any excipient contained in ADG206.
- Pregnant, lactating, or breastfeeding.
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE1
Study ID
NCT05614258
Intervention or treatment
DRUG: ADG206
Conditions
- Advanced/Metastatic Solid Tumors
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Research sites nearby
Closest Location:
Ashford Cancer Centre Research
Select from list below to view details:
Ashford Cancer Centre Research
Kurralta Park, South Australia, Australia
Monash Health
Clayton, Victoria, Australia
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Who is running the clinical trial?
Adagene Inc
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
| Measure | Description | 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
| Measure | Description | 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) |
References
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