Advanced/Metastatic Solid TumorsPhase 1NCT05614258
Study of ADG206 in Subjects With Advanced/Metastatic Solid Tumors
A Phase 1 study testing ADG206 in people with Advanced/Metastatic Solid Tumors, run by Adagene Inc at 2 sites in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced/Metastatic Solid Tumors
- What is being tested?
- ADG206
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesAustralia
- Study dates
- 13 Feb 2023to 30 Aug 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Monash Health
Clayton, Victoria, 3168
Ashford Cancer Centre Research
Kurralta Park, South Australia, 5037
About this study
Official title: A First-in-Human (FIH), Open-Label, Phase 1 Study of ADG206, a CD137 Agonist Antibody, 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.
Read the detailed description
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.
- Conditions
- Advanced/Metastatic Solid Tumors
- Being tested
- ADG206
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADG206Drug
All participants in this study will receive the study drug ADG206 in one of the designed dosage level. ADG206 will be administered by intravenous infusion over 60-90 minutes on Day 1 of each treatment cycle until disease progression, intolerable toxicities or withdrawal of consent, or up to 2 years.
| Study group | Role | What they receive |
|---|---|---|
| ADG206 dose escalation | Experimental | Not described Receives: Drug: ADG206 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants experiencing dose-limiting toxicities escalating dose levels
Measured: At the end of Cycle 1 (each cycle is 21 days)
Number of participants with adverse events (AE)
Measured: At the end of 90 days post last dose (each cycle is 21 days)
Maximum administered dose (MAD) of ADG206
Measured: At the end of the last dose (each cycle is 21 days)
Maximum tolerated dose (MTD) of ADG 206
Measured: At the end of the last dose (each cycle is 21 days)
Recommended Phase 2 dose (RP2D) of ADG206
Measured: At the end of the last dose (each cycle is 21 days)
Secondary outcomes (5)
The area under the curve (AUC) of plasma concentration of drug
Measured: At the end of the last dose (each cycle is 21 days)
Immunogenicity endpoints include antidrug antibodies (ADAs)
Measured: At the end of the last dose (each cycle is 21 days)
Maximum concentration (Cmax)
Measured: At the end of the last dose (each cycle is 21 days)
Time to maximum plasma concentration (Tmax)
Measured: At the end of the last dose (each cycle is 21 days)
Lowest plasma concentration (C[trough])
Measured: At the end of the last dose (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start13 Feb 2023
- Primary completion25 Jun 2025
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced/Metastatic Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adagene Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05614258
- Sponsor's protocol ID
- ADG206-1001
- Status last verified
- Jan 2026
- First submitted
- 27 Oct 2022
- Last updated
- 8 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Singh R, Kim YH, Lee SJ, Eom HS, Choi BK. 4-1BB immunotherapy: advances and hurdles. Exp Mol Med. 2024 Feb;56(1):32-39. doi: 10.1038/s12276-023-01136-4. Epub 2024 Jan 4.
PubMed 38172595
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human (FIH), Open-Label, Phase 1 Study of ADG206, a CD137 Agonist Antibody, in Subjects With Advanced/Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT05614258
- Acronym / sponsor ID
- ADG206-1001
- Conditions
- Advanced/Metastatic Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Adagene IncIndustry (pharma, biotech, devices)
- Study start
- 13 Feb 2023 (actual)
- Primary completion
- 25 Jun 2025 (actual)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADG206 dose escalation | Experimental | Drug: ADG206 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADG206All participants in this study will receive the study drug ADG206 in one of the designed dosage level. ADG206 will be administered by intravenous infusion over 60-90 minutes on Day 1 of each treatment cycle until disease progression, intolerable toxicities or withdrawal of consent, or up to 2 years. | Drug | ADG206 dose escalation |
Primary outcome
Number of participants experiencing dose-limiting toxicities escalating dose levels
Time frame: At the end of Cycle 1 (each cycle is 21 days)
Number of participants with adverse events (AE)
Time frame: At the end of 90 days post last dose (each cycle is 21 days)
Maximum administered dose (MAD) of ADG206
Time frame: At the end of the last dose (each cycle is 21 days)
Maximum tolerated dose (MTD) of ADG 206
Time frame: At the end of the last dose (each cycle is 21 days)
Recommended Phase 2 dose (RP2D) of ADG206
Time frame: At the end of the last dose (each cycle is 21 days)
5 secondary outcomes
The area under the curve (AUC) of plasma concentration of drug
Time frame: At the end of the last dose (each cycle is 21 days)
Immunogenicity endpoints include antidrug antibodies (ADAs)
Time frame: At the end of the last dose (each cycle is 21 days)
Maximum concentration (Cmax)
Time frame: At the end of the last dose (each cycle is 21 days)
Time to maximum plasma concentration (Tmax)
Time frame: At the end of the last dose (each cycle is 21 days)
Lowest plasma concentration (C[trough])
Time frame: At the end of the last dose (each cycle is 21 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Derived from this study: PubMed 38172595Singh R, Kim YH, Lee SJ, Eom HS, Choi BK. 4-1BB immunotherapy: advances and hurdles. Exp Mol Med. 2024 Feb;56(1):32-39. doi: 10.1038/s12276-023-01136-4. Epub 2024 Jan 4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ADG206 in people with Advanced/Metastatic Solid Tumors, run by Adagene Inc at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants experiencing dose-limiting toxicities escalating dose levels (time frame: At the end of Cycle 1 (each cycle is 21 days)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05614258, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.