Solid TumorPhase 1NCT04111445
Study of ADG116 in Patients With Advanced/Metastatic Solid Tumors
A Phase 1 study testing ADG116 in people with Solid Tumor, run by Adagene Inc at 1 site in United States.
Trial summary
This is a FIH, open-label, Phase I dose-escalation study of ADG116 in subjects with advanced/metastatic solid tumors. Study drug, ADG116, is an anti -CTLA-4 fully human monoclonal antibody that specifically binds to human CTLA-4. ADG 116 administered intravenously (IV) over a period of 60-90 minutes. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- ADG116
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2019to 27 Apr 2021
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, 18-75 years of age at the time of consent.
- Provide written informed consent.
- Subjects with advanced and/or metastatic histologically or cytologically confirmed solid tumor who have not responded or progressed after standard therapies or for whom no further standard therapy exists or standard therapy is not available
- Patients who are refractory or relapsed to prior anti-CTLA4 checkpoint inhibitors will also be recruited if they meet all eligibility criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status < 2.
- Adequate organ and bone marrow function
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within the 7 days prior to study
Who cannot join
- Pregnant or nursing females.
- Treatment with any investigational drug within 4 weeks prior to the first dose of study drug
- Grade ≥ 3 immune-related adverse events (irAE) or irAE that lead to discontinuation of prior immunotherapy. Untreated or uncontrolled central nervous system (CNS) tumors or metastases
- Any active autoimmune disease or documented history of autoimmune disease.
- Infection of human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
- Subjects requiring systemic treatment with corticosteroids or other immunosuppressive medications within 21 days before the planned first dose of study drug.
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- Current or prior history of pneumonitis, hepatitis, nephritis, colitis or thyroiditis. Peripheral neuropathy ≥ Grade 2.
- History of clinically significant cardiac disease.
- Uncontrolled current illness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: First-in-human (FIH), Open-Label, Phase I (Dose Escalation) Study of ADG116 in Patients With Advanced/Metastatic Solid Tumors
This is a FIH, open-label, Phase I dose-escalation study of ADG116 in subjects with advanced/metastatic solid tumors. Study drug, ADG116, is an anti -CTLA-4 fully human monoclonal antibody that specifically binds to human CTLA-4. ADG 116 administered intravenously (IV) over a period of 60-90 minutes. The study planned to treated 42 patients.
- Conditions
- Solid Tumor
- Being tested
- ADG116
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADG116Drug
IV infusion at Day 1 of each cycle
| Study group | Role | What they receive |
|---|---|---|
| ADG116 | Experimental | Not described Receives: Drug: ADG116 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants experiencing dose-limiting toxicities
Measured: From first dose of ADG116 (Week 1 Day 1) until 30days after the last ADG116 injection (up to 2 years)
Number of participants experiencing clinical and laboratory adverse events (AEs)
Measured: From first dose of ADG116 (Week 1 Day 1) until 30days after the last ADG116 injection (up to 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start29 Aug 2019
- Primary completion27 Apr 2021
- Study completion27 Apr 2021
Why it stopped: Study discontinued due to business decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- 1 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
- NCT04111445
- Sponsor's protocol ID
- ADG116-1001
- Status last verified
- Sep 2021
- First submitted
- 11 Sep 2019
- Last updated
- 10 Sep 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-in-human (FIH), Open-Label, Phase I (Dose Escalation) Study of ADG116 in Patients With Advanced/Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT04111445
- Acronym / sponsor ID
- ADG116-1001
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study discontinued due to business decision.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Adagene IncIndustry (pharma, biotech, devices)
- Study start
- 29 Aug 2019 (actual)
- Primary completion
- 27 Apr 2021 (actual)
- Study completion
- 27 Apr 2021 (actual)
- First posted
- 1 Oct 2019 (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 FIH, open-label, Phase I dose-escalation study of ADG116 in subjects with advanced/metastatic solid tumors. Study drug, ADG116, is an anti -CTLA-4 fully human monoclonal antibody that specifically binds to human CTLA-4. ADG 116 administered intravenously (IV) over a period of 60-90 minutes. The study planned to treated 42 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADG116 | Experimental | Drug: ADG116 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female, 18-75 years of age at the time of consent.
- Provide written informed consent.
- Subjects with advanced and/or metastatic histologically or cytologically confirmed solid tumor who have not responded or progressed after standard therapies or for whom no further standard therapy exists or standard therapy is not available
- Patients who are refractory or relapsed to prior anti-CTLA4 checkpoint inhibitors will also be recruited if they meet all eligibility criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status < 2.
Key exclusion criteria (9 listed)
- Pregnant or nursing females.
- Treatment with any investigational drug within 4 weeks prior to the first dose of study drug
- Grade ≥ 3 immune-related adverse events (irAE) or irAE that lead to discontinuation of prior immunotherapy. Untreated or uncontrolled central nervous system (CNS) tumors or metastases
- Any active autoimmune disease or documented history of autoimmune disease.
- Infection of human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
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 |
|---|---|---|
| ADG116IV infusion at Day 1 of each cycle | Drug | ADG116 |
Primary outcome
Number of participants experiencing dose-limiting toxicities
Time frame: From first dose of ADG116 (Week 1 Day 1) until 30days after the last ADG116 injection (up to 2 years)
Number of participants experiencing clinical and laboratory adverse events (AEs)
Time frame: From first dose of ADG116 (Week 1 Day 1) until 30days after the last ADG116 injection (up to 2 years)
Results and safety
The study was stopped early (reason given: Study discontinued due to business decision.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ADG116 in people with Solid Tumor, run by Adagene Inc at 1 site in United States.
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 7 inclusion and 9 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: stopped early, as of the sponsor's last update on 10 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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 was stopped early (reason given: Study discontinued due to business decision.). Results are not available in the source record.
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 (time frame: From first dose of ADG116 (Week 1 Day 1) until 30days after the last ADG116 injection (up to 2 years)). 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?
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 10 Sep 2021.