Experimental antibody ADG206 targets Hard-to-Treat cancers in first human trial
NCT ID NCT05614258
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase study tests a new drug called ADG206 in 14 people with advanced solid tumors that have not responded to standard treatments. ADG206 is an antibody designed to activate the immune system by targeting CD137, a protein on immune cells. The main goals are to check safety, find the right dose, and see how the body handles the drug.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ADG206 (a CD137 agonist antibody)
- What this could lead to
- If successful, this could point toward a new treatment option for advanced solid tumors that have stopped responding to standard therapies.
- What could go wrong
- This is a very early Phase 1 trial with only 14 participants, so safety and effectiveness are not yet known. The drug may cause side effects or fail to shrink tumors.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
14 people
The number who actually took part.
- Started
-
Feb 2023
- Expected to finish
-
Aug 2026
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Ashford Cancer Centre Research
Kurralta Park, South Australia, 5037, Australia
-
Monash Health
Clayton, Victoria, 3168, Australia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- First-in-Human trial asks whether HG381 is safe and tolerable in advanced solid tumors
- Custom-Built immune cells take aim at a notorious cancer mutation
- Experimental injection SHR-7787 put to the test against advanced solid tumors
- Experimental biologic AWT020 put to the test in Hard-to-Treat cancers
- Can a pill shrink Hard-to-Treat ovarian tumors?
- Oral drug RVU120 put to the test against advanced solid tumors