Advanced/Metastatic Solid TumorsPhase 1NCT04501276
A Phase 1b/2 Study of ADG116, ADG116 Combined With Anti-PD-1 Antibody or Anti-CD137 Antibody in Solid Tumors Patients
A Phase 1 study testing ADG116, ADG106 and anti PD1 drug in people with Advanced/Metastatic Solid Tumors, run by Adagene Inc at 4 sites in 2 countries.
Trial summary
This is a Phase 1, open-label, dose escalation study in patients with advanced/metastatic solid tumors. Study drug, ADG116, is an anti -CTLA-4 fully human monoclonal antibody that specifically binds to human CTLA-4. 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?
- ADG116, ADG106 and anti PD1 drug
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 23 Sep 2020to 30 Nov 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Patients must meet all of the following inclusion criteria to be eligible for participation in this study:
- ≥ 18 years of age at the time of informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Patients with advanced or metastatic solid tumors, who have progressed after all standard therapies, or for whom no further standard therapy exists.
- At least 1 measurable lesion at baseline according to the definition of RECIST v1.1.
- Adequate organ function.
Who cannot join
- Patients who meet any of the following criteria cannot be enrolled:
- Pregnant or breastfeeding females.
- Childbearing potential who does not agree to the use of contraception during the treatment period..
- Treatment with any investigational drug within washout period.
- Grade ≥ 3 immune-related AEs (irAEs) or irAE that lead to discontinuation of prior immunotherapy.
- Central nervous system disease involvement
Show all 13Show fewer
- History or risk of autoimmune disease.
- 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.
- Patients requiring systemic treatment with corticosteroids
- Patients receiving granulocyte colony stimulating factor (G-CSF), within 14 days prior to the first dose of the study drug.
- Any uncontrolled active infections requiring systemic antimicrobial treatment (viral, bacterial, or other), or uncontrolled or poorly controlled, asthma, chronic obstructive pulmonary disease (COPD).
- Major surgery within 4 weeks prior to the first dose of the study drug.
- Has had an allogeneic tissue/solid organ transplant.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Australia3 sites
Ashford Cancer Centre Research
Kurralta Park
Cabrini Hospital
Malvern
Macquarie University
Sydney
About this study
Official title: A Phase 1b/2, Open-Label, Dose Escalation and Expansion Study of ADG116, ADG116 Combined With Toripalimab (Anti-PD-1 Antibody), ADG116 Combined With ADG106 (Anti-CD137 Antibody) in Patients With Advanced/Metastatic Solid Tumors
This is a Phase 1, open-label, dose escalation study in patients with advanced/metastatic solid tumors. Study drug, ADG116, is an anti -CTLA-4 fully human monoclonal antibody that specifically binds to human CTLA-4. ADG106, a fully human ligand-blocking agonistic anti-CD137 IgG4 mAb, is expected to enhance the activity of activated T cells. The enhanced antitumor efficacy results observed from the preclinical studies of ADG116 in combination with ADG106 or anti-PD-1 provided further support to explore such combinations in clinical settings for better patient responses.
- Conditions
- Advanced/Metastatic Solid Tumors
- Being tested
- ADG116, ADG106, anti PD1 drug
- Keywords
- Advanced/Metastatic Solid Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADG116Drug
For monotherapy ADG116 (Part A), ADG116 will be administered IV over 60 90 minutes until disease progression, intolerable toxicities, or withdrawal of consent, or up to 2 years.
ADG106Drug
For the ADG116-ADG106 combination regimen, ADG116 and ADG106 will be administered until disease progression, intolerable toxicities, or withdrawal of consent, or up to 2 years.
anti PD1 drugDrug
For the ADG116-anti PD1 combination regimen, ADG116 and anti PD1 will be administered until disease progression, intolerable toxicities, or withdrawal of consent, or up to 2 years.
| Study group | Role | What they receive |
|---|---|---|
| Part A : Dose escalation of ADG116 monotherapy | Experimental | Not described Receives: Drug: ADG116 |
| Part B : Dose escalation of ADG116 combined with anti PD1 drug | Experimental | Not described Receives: Drug: ADG116; Drug: anti PD1 drug |
| Part C : Dose escalation of ADG116 combined with ADG106 | Experimental | Not described Receives: Drug: ADG116; Drug: ADG106 |
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 in adults with advanced / metastatic solid tumors
Measured: From first dose of ADG116 (Week 1 Day 1) until 21 days
Number of participants with adverse events as assessed by CTCAE v5.0
Measured: From first dose of ADG116 (Week 1 Day 1) to 28 days post last dose
Secondary outcomes (6)
Area under the time concentration curve (AUC) from time zero to infinity (AUC0-inf)
Measured: From first dose (Cycle 1 Day 1, ) until the last dose (up to 2 years)
Maximum (peak) plasma concentration (Cmax)
Measured: From first dose (Cycle 1 Day 1,) until the last dose (up to 2 years)
Time to maximum (peak) plasma concentration (Tmax)
Measured: From first dose (Cycle 1 Day 1,) until the last dose (up to 2 years)
Trough plasma concentration (Ctrough)
Measured: From first dose (Cycle 1 Day 1,) until the last dose (up to 2 years)
Incidence of ADAs
Measured: From first dose (Cycle 1 Day 1,) until the last dose (up to 2 years)
Preliminary evidence of antitumor activity as characterized by objective response rate (ORR), disease control rate (DCR), duration of response (DOR), duration of stable disease, progression free survival (PFS), and overall survival (OS).
Measured: From first dose of ADG116 (Week 1 Day 1) to 28 days post last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start23 Sep 2020
- Primary completion17 Jan 2024
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 72 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
- NCT04501276
- Sponsor's protocol ID
- ADG116-1003
- Status last verified
- Jan 2026
- First submitted
- 29 Jul 2020
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brahmer JR, Lacchetti C, Schneider BJ, Atkins MB, Brassil KJ, Caterino JM, Chau I, Ernstoff MS, Gardner JM, Ginex P, Hallmeyer S, Holter Chakrabarty J, Leighl NB, Mammen JS, McDermott DF, Naing A, Nastoupil LJ, Phillips T, Porter LD, Puzanov I, Reichner CA, Santomasso BD, Seigel C, Spira A, Suarez-Almazor ME, Wang Y, Weber JS, Wolchok JD, Thompson JA; National Comprehensive Cancer Network. Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy: American Society of Clinical Oncology Clinical Practice Guideline. J Clin Oncol. 2018 Jun 10;36(17):1714-1768. doi: 10.1200/JCO.2017.77.6385. Epub 2018 Feb 14.
PubMed 29442540Melero I, Hervas-Stubbs S, Glennie M, Pardoll DM, Chen L. Immunostimulatory monoclonal antibodies for cancer therapy. Nat Rev Cancer. 2007 Feb;7(2):95-106. doi: 10.1038/nrc2051.
PubMed 17251916Finn OJ. Immuno-oncology: understanding the function and dysfunction of the immune system in cancer. Ann Oncol. 2012 Sep;23 Suppl 8(Suppl 8):viii6-9. doi: 10.1093/annonc/mds256.
PubMed 22918931
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 Phase 1b/2, Open-Label, Dose Escalation and Expansion Study of ADG116, ADG116 Combined With Toripalimab (Anti-PD-1 Antibody), ADG116 Combined With ADG106 (Anti-CD137 Antibody) in Patients With Advanced/Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT04501276
- Acronym / sponsor ID
- ADG116-1003
- Conditions
- Advanced/Metastatic Solid Tumors
- Keywords
- Advanced/Metastatic Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Adagene IncIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2020 (actual)
- Primary completion
- 17 Jan 2024 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 6 Aug 2020 (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.
This is a Phase 1, open-label, dose escalation study in patients with advanced/metastatic solid tumors. Study drug, ADG116, is an anti -CTLA-4 fully human monoclonal antibody that specifically binds to human CTLA-4. ADG106, a fully human ligand-blocking agonistic anti-CD137 IgG4 mAb, is expected to enhance the activity of activated T cells. The enhanced antitumor efficacy results observed from the preclinical studies of ADG116 in combination with ADG106 or anti-PD-1 provided further support to explore such combinations in clinical settings for better patient responses.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A : Dose escalation of ADG116 monotherapy | Experimental | Drug: ADG116 |
| Part B : Dose escalation of ADG116 combined with anti PD1 drug | Experimental | Drug: ADG116, Drug: anti PD1 drug |
| Part C : Dose escalation of ADG116 combined with ADG106 | Experimental | Drug: ADG116, Drug: ADG106 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients must meet all of the following inclusion criteria to be eligible for participation in this study:
- ≥ 18 years of age at the time of informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Patients with advanced or metastatic solid tumors, who have progressed after all standard therapies, or for whom no further standard therapy exists.
- At least 1 measurable lesion at baseline according to the definition of RECIST v1.1.
Key exclusion criteria (13 listed)
- Patients who meet any of the following criteria cannot be enrolled:
- Pregnant or breastfeeding females.
- Childbearing potential who does not agree to the use of contraception during the treatment period..
- Treatment with any investigational drug within washout period.
- Grade ≥ 3 immune-related AEs (irAEs) or irAE that lead to discontinuation of prior immunotherapy.
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 |
|---|---|---|
| ADG116For monotherapy ADG116 (Part A), ADG116 will be administered IV over 60 90 minutes until disease progression, intolerable toxicities, or withdrawal of consent, or up to 2 years. | Drug | Part A : Dose escalation of ADG116 monotherapy, Part B : Dose escalation of ADG116 combined with anti PD1 drug, Part C : Dose escalation of ADG116 combined with ADG106 |
| ADG106For the ADG116-ADG106 combination regimen, ADG116 and ADG106 will be administered until disease progression, intolerable toxicities, or withdrawal of consent, or up to 2 years. | Drug | Part C : Dose escalation of ADG116 combined with ADG106 |
| anti PD1 drugFor the ADG116-anti PD1 combination regimen, ADG116 and anti PD1 will be administered until disease progression, intolerable toxicities, or withdrawal of consent, or up to 2 years. | Drug | Part B : Dose escalation of ADG116 combined with anti PD1 drug |
Primary outcome
Number of participants experiencing dose-limiting toxicities escalating dose levels in adults with advanced / metastatic solid tumors
Time frame: From first dose of ADG116 (Week 1 Day 1) until 21 days
Number of participants with adverse events as assessed by CTCAE v5.0
Time frame: From first dose of ADG116 (Week 1 Day 1) to 28 days post last dose
6 secondary outcomes
Area under the time concentration curve (AUC) from time zero to infinity (AUC0-inf)
Time frame: From first dose (Cycle 1 Day 1, ) until the last dose (up to 2 years)
Maximum (peak) plasma concentration (Cmax)
Time frame: From first dose (Cycle 1 Day 1,) until the last dose (up to 2 years)
Time to maximum (peak) plasma concentration (Tmax)
Time frame: From first dose (Cycle 1 Day 1,) until the last dose (up to 2 years)
Trough plasma concentration (Ctrough)
Time frame: From first dose (Cycle 1 Day 1,) until the last dose (up to 2 years)
Incidence of ADAs
Time frame: From first dose (Cycle 1 Day 1,) until the last dose (up to 2 years)
Preliminary evidence of antitumor activity as characterized by objective response rate (ORR), disease control rate (DCR), duration of response (DOR), duration of stable disease, progression free survival (PFS), and overall survival (OS).
Time frame: From first dose of ADG116 (Week 1 Day 1) to 28 days post last dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Background: PubMed 29442540Brahmer JR, Lacchetti C, Schneider BJ, Atkins MB, Brassil KJ, Caterino JM, Chau I, Ernstoff MS, Gardner JM, Ginex P, Hallmeyer S, Holter Chakrabarty J, Leighl NB, Mammen JS, McDermott DF, Naing A, Nastoupil LJ, Phillips T, Porter LD, Puzanov I, Reichner CA, Santomasso BD, Seigel C, Spira A, Suarez-Almazor ME, Wang Y, Weber JS, Wolchok JD, Thompson JA; National Comprehensive Cancer Network. Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy: American Society of Clinical Oncology Clinical Practice Guideline. J Clin Oncol. 2018 Jun 10;36(17):1714-1768. doi: 10.1200/JCO.2017.77.6385. Epub 2018 Feb 14.
- Background: PubMed 17251916Melero I, Hervas-Stubbs S, Glennie M, Pardoll DM, Chen L. Immunostimulatory monoclonal antibodies for cancer therapy. Nat Rev Cancer. 2007 Feb;7(2):95-106. doi: 10.1038/nrc2051.
- Background: PubMed 22918931Finn OJ. Immuno-oncology: understanding the function and dysfunction of the immune system in cancer. Ann Oncol. 2012 Sep;23 Suppl 8(Suppl 8):viii6-9. doi: 10.1093/annonc/mds256.
- 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.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ADG116, ADG106 and anti PD1 drug in people with Advanced/Metastatic Solid Tumors, run by Adagene Inc at 4 sites in 2 countries.
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 13 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: finished, 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 4 sites in Australia, United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 in adults with advanced / metastatic solid tumors (time frame: From first dose of ADG116 (Week 1 Day 1) until 21 days). The study lists 2 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 NCT04501276, which also lists 3 linked publications.
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.