Experimental antibody combo tackles Hard-to-Treat cancers
NCT ID NCT04501276
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tested an experimental drug called ADG116, which helps the immune system attack cancer cells. The study included 72 adults with advanced solid tumors that had stopped responding to standard treatments. Some participants received ADG116 alone, while others got it combined with another immune drug (toripalimab or ADG106). The main goals were to check safety and find the right dose.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ADG116 (an experimental antibody that targets CTLA-4 on immune cells)
- What this could lead to
- If it works, this could point toward a new treatment option for people with advanced solid tumors who have run out of standard therapies.
- What could go wrong
- This is a very early Phase 1 trial with only 72 participants, so it is primarily testing safety and dosing. The drug may not shrink tumors or may cause side effects.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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72 people
The number who actually took part.
- Started
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Sep 2020
- Finished
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Nov 2025
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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: Patients must meet all of the following inclusion criteria to be eligible for participation in this study: 1. ≥ 18 years of age at the time of informed consent. 2. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 3. Patients with advanced or metastatic solid tumors, who have progressed after all standard therapies, or for whom no further standard therapy exists. 4. At least 1 measurable lesion at baseline according to the definition of RECIST v1.1. 5. Adequate organ function. Exclusion Criteria: • Patients who meet any of the following criteria cannot be enrolled: 1. Pregnant or breastfeeding females. 2. Childbearing potential who does not agree to the use of contraception during the treatment period.. 3. Treatment with any investigational drug within washout period. 4. Grade ≥ 3 immune-related AEs (irAEs) or irAE that lead to discontinuation of prior immunotherapy. 5. Central nervous system disease involvement 6. History or risk of autoimmune disease. 7. History of life-threatening hypersensitivity or known to be allergic to protein drugs or recombinant proteins or any ingredients contained in the ADG116 drug formulation. 8. Patients requiring systemic treatment with corticosteroids 9. Patients receiving granulocyte colony stimulating factor (G-CSF), within 14 days prior to the first dose of the study drug. 10. Any uncontrolled active infections requiring systemic antimicrobial treatment (viral, bacterial, or other), or uncontrolled or poorly controlled, asthma, chronic obstructive pulmonary disease (COPD). 11. Major surgery within 4 weeks prior to the first dose of the study drug. 12. Has had an allogeneic tissue/solid organ transplant.
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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
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Ashford Cancer Centre Research
Kurralta Park, Australia
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Cabrini Hospital
Malvern, Australia
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Macquarie University
Sydney, Australia
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Next Oncology
San Antonio, Texas, 78229, United States
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