Advanced/Metastatic Solid TumorsPhase 1/2NCT04645069
ADG126, ADG126 in Combination With Anti PD1 Antibody, and ADG126 in Combination With ADG106 in Advanced/Metastatic Solid Tumors
A Phase 1/2 study testing ADG126 Mono, ADG126-anti PD1 and ADG126-ADG106 in people with Advanced/Metastatic Solid Tumors, run by Adagene Inc at 9 sites in 3 countries.
Trial summary
ADG126, ADG126 in Combination with anti-PD1 antibody, and ADG126 in Combination with ADG106 in Patients with Advanced/Metastatic Solid Tumors . 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?
- ADG126 Mono, ADG126-anti PD1 and ADG126-ADG106
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 15 Mar 2021to 17 May 2024
- Phase
- Phase 1/2
- 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
- Adults ≥18 years of age.
- ECOG performance status 0 or 1.
- Estimated life expectancy of more than 12 weeks .
- Patients with advanced or metastatic solid tumors, confirmed by histologically or pathologically documented, 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.
- Meets the additional tumor type requirements as specified in Protocol.
Who cannot join
- Treatment with any investigational drug within washout period.
- Major trauma or major surgery within 4 weeks prior to first dose of study drug(s)
- History of significant immune-mediated AE.
- Central nervous system (CNS) disease involvement.
- Prior organ allograft transplantations or allogeneic peripheral blood stem cell (PBSC)/bone marrow (BM) transplantation
- Clinically significant cardiac disease.
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- Evidence of active uncontrolled viral, bacterial, or systemic fungal infection.
- Patients who received:
- A COVID-19 vaccine within 7 days of Cycle 1 Day 1.
- Live vaccines or live-attenuated vaccines within 28 days prior to Cycle 1 Day 1.
- Known active infection of HBV/BCV/HIV.
- Patients requiring systemic treatment with corticosteroids or other immunosuppressive medications (>10 mg/day prednisone or equivalent).
- Second primary malignancy not in remission for greater than 3 years.
- History(within the last 5 years) or risk of autoimmune disease.
- Pregnant or breastfeeding females.
- Childbearing potential who does not agree to the use of contraception during the treatment period.
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
Australia5 sites
Sunshine Coast University Private Hospital
Birtinya, Queensland, 4575
Cabrini Health Limited
Malvern, Victoria, 3144
Southside Cancer Care Centre
Miranda, New South Wales, 2228
One Clinical Research Pty Ltd
Nedlands, Western Australia, 6009
Macquarie University Hospital
Sydney, New South Wales
United States2 sites
University of California Los Angeles
Los Angeles, California, 90095
Next oncology
San Antonio, Texas, 78229
Singapore2 sites
National University Hospital
Singapore, 119074
National Cancer Centre Singapore
Singapore, 169610
About this study
Official title: A First-in-Human (FIH), Open-Label, Phase 1/2 Dose Escalation and Expansion Study of ADG126, ADG126 in Combination With Anti PD1 Antibody, and ADG126 in Combination With ADG106 in Patients With Advanced/Metastatic Solid Tumors
ADG126, ADG126 in Combination with anti-PD1 antibody, and ADG126 in Combination with ADG106 in Patients with Advanced/Metastatic Solid Tumors .
Read the detailed description
ADG126 is a novel anti-CTLA-4 fully human IgG1 antibody prodrug that is modified with Adagene Safebody technology to control the activation of anti-CTLA4 activity.ADG106 is a fully human ligand-blocking, agonistic anti-CD137 IgG4 mAb which is expected to enhance the activity of activated T cells. The enhanced antitumor efficacy results observed from the preclinical studies of ADG126 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
- ADG126 Mono, ADG126-anti PD1, ADG126-ADG106
- Keywords
- Advanced/Metastatic Solid Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADG126 MonoBiological
ADG126 will be administered as an IV infusion over 30-60 minutes ± 15 minutes.
ADG126-anti PD1Biological
ADG126-toripalimab combination regimen will receive of toripalimab 15 to 30 minutes after the end of the ADG126 infusion
ADG126-ADG106Biological
ADG126-ADG106 combination regimen will be receive of ADG106 15 to 30 minutes after the end of the ADG126 infusion
| Study group | Role | What they receive |
|---|---|---|
| ADG126 mono dose escalation | Experimental | ADG126 monotherapy dose escalation will be traditional 3+3 cohort design. Receives: Biological: ADG126 Mono |
| ADG126 mono dose expansion | Experimental | Monotherapy dose expansion is designed to evaluate the preliminary antitumor activity of ADG126 at RP2D or the doses approved by the SRC. Receives: Biological: ADG126 Mono |
| ADG126-anti PD1 drug dose escalation | Experimental | Combination therapy will commence at a dose level lower than the cleared dose from the monotherapy dose escalation arms and approved by the SRC. Receives: Biological: ADG126-anti PD1 |
| ADG126-anti PD1 drug dose expansion | Experimental | Combination therapy expansion will commence at RP2D or the dose approved by the SRC. Receives: Biological: ADG126-anti PD1 |
| ADG126-ADG106 dose escalation | Experimental | Combination therapy will commence at a dose level lower than the cleared dose from the monotherapy dose escalation arms and approved by the SRC. Receives: Biological: ADG126-ADG106 |
| ADG126-ADG106 dose expansion | Experimental | Combination therapy expansion will commence at RP2D or the dose approved by the SRC. Receives: Biological: ADG126-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 ADG126 (Week 1 Day 1) until 21 days
Number of participants with adverse events as assessed by CTCAE v5.0 ADG126-ADG106 combination regimens
Measured: From first dose of ADG126 (Week 1 Day 1) to 90 days post last dose
Secondary outcomes (5)
Antidrug antibodies (ADAs)
Measured: From first dose (Cycle 1 Day 1, ) until the last dose (up to 2 years)
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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2020
- Study start15 Mar 2021
- Primary completion29 Jan 2024
- Study completion17 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 58 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
- NCT04645069
- Sponsor's protocol ID
- ADG126-1001
- Status last verified
- Aug 2024
- First submitted
- 20 Nov 2020
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human (FIH), Open-Label, Phase 1/2 Dose Escalation and Expansion Study of ADG126, ADG126 in Combination With Anti PD1 Antibody, and ADG126 in Combination With ADG106 in Patients With Advanced/Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT04645069
- Acronym / sponsor ID
- ADG126-1001
- Conditions
- Advanced/Metastatic Solid Tumors
- Keywords
- Advanced/Metastatic Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Adagene IncIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 29 Jan 2024 (actual)
- Study completion
- 17 May 2024 (actual)
- First posted
- 27 Nov 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.
ADG126, ADG126 in Combination with anti-PD1 antibody, and ADG126 in Combination with ADG106 in Patients with Advanced/Metastatic Solid Tumors .
Detailed description
ADG126 is a novel anti-CTLA-4 fully human IgG1 antibody prodrug that is modified with Adagene Safebody technology to control the activation of anti-CTLA4 activity.ADG106 is a fully human ligand-blocking, agonistic anti-CD137 IgG4 mAb which is expected to enhance the activity of activated T cells. The enhanced antitumor efficacy results observed from the preclinical studies of ADG126 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
- 6
| Arm | Type | Receives |
|---|---|---|
| ADG126 mono dose escalation | Experimental | Biological: ADG126 MonoADG126 monotherapy dose escalation will be traditional 3+3 cohort design. |
| ADG126 mono dose expansion | Experimental | Biological: ADG126 MonoMonotherapy dose expansion is designed to evaluate the preliminary antitumor activity of ADG126 at RP2D or the doses approved by the SRC. |
| ADG126-anti PD1 drug dose escalation | Experimental | Biological: ADG126-anti PD1Combination therapy will commence at a dose level lower than the cleared dose from the monotherapy dose escalation arms and approved by the SRC. |
| ADG126-anti PD1 drug dose expansion | Experimental | Biological: ADG126-anti PD1Combination therapy expansion will commence at RP2D or the dose approved by the SRC. |
| ADG126-ADG106 dose escalation | Experimental | Biological: ADG126-ADG106Combination therapy will commence at a dose level lower than the cleared dose from the monotherapy dose escalation arms and approved by the SRC. |
| ADG126-ADG106 dose expansion | Experimental | Biological: ADG126-ADG106Combination therapy expansion will commence at RP2D or the dose approved by the SRC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults ≥18 years of age.
- ECOG performance status 0 or 1.
- Estimated life expectancy of more than 12 weeks .
- Patients with advanced or metastatic solid tumors, confirmed by histologically or pathologically documented, 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 (16 listed)
- Treatment with any investigational drug within washout period.
- Major trauma or major surgery within 4 weeks prior to first dose of study drug(s)
- History of significant immune-mediated AE.
- Central nervous system (CNS) disease involvement.
- Prior organ allograft transplantations or allogeneic peripheral blood stem cell (PBSC)/bone marrow (BM) transplantation
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 |
|---|---|---|
| ADG126 MonoADG126 will be administered as an IV infusion over 30-60 minutes ± 15 minutes. | Biological | ADG126 mono dose escalation, ADG126 mono dose expansion |
| ADG126-anti PD1ADG126-toripalimab combination regimen will receive of toripalimab 15 to 30 minutes after the end of the ADG126 infusion | Biological | ADG126-anti PD1 drug dose escalation, ADG126-anti PD1 drug dose expansion |
| ADG126-ADG106ADG126-ADG106 combination regimen will be receive of ADG106 15 to 30 minutes after the end of the ADG126 infusion | Biological | ADG126-ADG106 dose escalation, ADG126-ADG106 dose expansion |
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 ADG126 (Week 1 Day 1) until 21 days
Number of participants with adverse events as assessed by CTCAE v5.0 ADG126-ADG106 combination regimens
Time frame: From first dose of ADG126 (Week 1 Day 1) to 90 days post last dose
5 secondary outcomes
Antidrug antibodies (ADAs)
Time frame: From first dose (Cycle 1 Day 1, ) until the last dose (up to 2 years)
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)
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 14 Aug 2024.
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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.
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ADG126 Mono, ADG126-anti PD1 and ADG126-ADG106 in people with Advanced/Metastatic Solid Tumors, run by Adagene Inc at 9 sites in 3 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 7 inclusion and 16 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 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Australia, United States, Singapore. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 ADG126 (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?
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 14 Aug 2024; AzTrials last refreshed its copy on 8 Nov 2026.