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Experimental antibody ADG206 targets Hard-to-Treat cancers in first human trial

NCT ID NCT05614258

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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

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