Solid TumorPhase 1/2NCT04775680
Study of ADG106 In Combination With PD-1 Antibody In Advanced or Metastatic Solid Tumors and/or Non Hodgkin Lymphoma
A Phase 1/2 study testing ADG106 injection and PD-1 antibody injection in people with Solid Tumor and Non Hodgkin Lymphoma, run by Adagene (Suzhou) Limited at 1 site in China.
Trial summary
This is a Multicenter, Open-Label, Phase Ib/II Study of ADG106 in Combination with PD-1 Antibody in Advanced Solid Tumors and Relapsed/Refractory Non-Hodgkin Lymphoma. The primary objective of Phase Ib: To evaluate the maximum tolerated dosage (MTD) of ADG106 in combination with PD-1 antibody in advanced solid tumors… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor, Non Hodgkin Lymphoma
- What is being tested?
- ADG106 injection and PD-1 antibody injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 11 Mar 2021to 9 Feb 2023
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with advanced solid tumors or relapses/refractory non-Hodgkin's lymphoma confirmed by histology or cytology
- Has at least one measurable lesion (solid tumor according to RECIST v1.1 criteria, non-Hodgkin's lymphoma according to Lugnao criteria)
- ECOG score of 0 or 1;
- Expected survival time ≥ 3 months (at the discretion of the investigator);
- Adequate organ and bone marrow function;
- Voluntarily sign the informed consent form;
Who cannot join
- Has central nervous system primary malignant tumor, active epileptic seizure, spinal cord compression or carcinomatous meningitis
- The previous anti-tumor treatment has not passed the prescribed washout period
- HIV antibody is positive, or with other acquired/congenital immunodeficiency disease, or with history of organ transplantation;
- Active hepatitis B or hepatitis C virus (HCV) antibody was positive;
- Patients who are pregnant or lactating;
- Known or suspected hypersensitivity to the study drug or its pharmaceutical excipients (including mono-hydrate citric acid, sodium di-hydrate citric acid, mannitol, polysorbate, arginine, succinic acid);
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- Any active autoimmune disease, or known history of autoimmune disease, or syndrome requiring systemic steroids or immunosuppressive medications (other than controlled thyroid disease with alternative therapy/non-immunosuppressive therapy);
- Participation in another therapeutic or interventional clinical study in the meantime;
- Other circumstances where the investigator considers it is not appropriate to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Open-Label, Phase Ib/II Study of ADG106 in Combination With PD-1 Antibody in Advanced Solid Tumors and Relapsed/Refractory Non-Hodgkin Lymphoma
This is a Multicenter, Open-Label, Phase Ib/II Study of ADG106 in Combination with PD-1 Antibody in Advanced Solid Tumors and Relapsed/Refractory Non-Hodgkin Lymphoma.
The primary objective of Phase Ib: To evaluate the maximum tolerated dosage (MTD) of ADG106 in combination with PD-1 antibody in advanced solid tumors and relapsed/refractory non-Hodgkin lymphoma, and to determine the recommended phase II clinical studies dosage (RP2D).
- Conditions
- Solid Tumor, Non Hodgkin Lymphoma
- Being tested
- ADG106 injection, PD-1 antibody injection
- Keywords
- Solid Tumor and Non Hodgkin Lymphoma
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADG106 injectionBiological
ADG106 injection, intravenous infusion, is administered as body weight every 3 weeks for 21 days as a cycle
PD-1 antibody injectionBiological
PD-1 antibody injection is administered as an intravenous infusion and at a dose of 240mg every 3 weeks for 21 days as a cycle
| Study group | Role | What they receive |
|---|---|---|
| ADG106 combined with PD-1 antibody Dose Escalation Level 1 | Experimental | Not described Receives: Biological: ADG106 injection; Biological: PD-1 antibody injection |
| ADG106 combined with anti PD-1 antibody Dose Escalation Level 2 | Experimental | Not described Receives: Biological: ADG106 injection; Biological: PD-1 antibody injection |
| ADG106 combined with anti PD-1 antibody Expansion Phase | Experimental | Not described Receives: Biological: ADG106 injection; Biological: PD-1 antibody injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants experiencing dosage limiting toxicity (DLT) in the first treatment cycle of the combination of ADG106 and PD-1 antibody.
Measured: From first dose of ADG106 and PD-1 antibody (Week 1 Day 1) until 21 days
Objective response rate (ORR) of the combination of ADG106 and PD-1 antibody in advanced solid tumors and relapsed/refractory non-hodgkin lymphoma
Measured: From baseline to measured progressive disease (up to 24 months)
Secondary outcomes (6)
Type of adverse event, incidence, grade (according to NCI CTCAE V 5.0 classification), onset time, and relationship to study treatment
Measured: From the first dose of ADG106 and PD-1 antibody (Week 1 Day 1) to 28 days post last dose
Area under the time concentration curve(AUC) from time zero to infinity (AUC0-inf))
Measured: From the first dose of ADG106 and PD-1 antibody (Cycle 1 Day 1,each cycle is 21 days) until the last dose (up to 2 years)
Maximum (peak) plasma concentration (Cmax)
Measured: From the first dose of ADG106 and PD-1 antibody (Cycle 1 Day 1,each cycle is 21 days) until the last dose (up to 2 years)
Time to maximum(peak) plasma concentration Tmax
Measured: From the first dose of ADG106 and PD-1 antibody (Cycle 1 Day 1,each cycle is 21 days) until the last dose (up to 2 years)
Through plasma concentration(Cthrough)
Measured: From the first dose of ADG106 and PD-1 antibody (Cycle 1 Day 1,each cycle is 21 days) until the last dose (up to 2 years)
Anti-drug antibody levels of ADG106 and PD-1 antibody
Measured: From the first dose of ADG106 and PD-1 antibody (Cycle 1 Day 1,each cycle is 21 days) 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 posted1 Mar 2021
- Study start11 Mar 2021
- Primary completion9 Feb 2023
- Study completion9 Feb 2023
Why it stopped: The safety of ADG106 combined with triprilimab has been fully understood.The overall clinical benefit of enrolled subjects was limited and further development of ADG106 was reconsidered.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adagene (Suzhou) Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04775680
- Sponsor's protocol ID
- ADG106-1008
- Status last verified
- Apr 2023
- First submitted
- 16 Feb 2021
- Last updated
- 24 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Phase Ib/II Study of ADG106 in Combination With PD-1 Antibody in Advanced Solid Tumors and Relapsed/Refractory Non-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT04775680
- Acronym / sponsor ID
- ADG106-1008
- Conditions
- Solid Tumor, Non Hodgkin Lymphoma
- Keywords
- Solid Tumor and Non Hodgkin Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The safety of ADG106 combined with triprilimab has been fully understood.The overall clinical benefit of enrolled subjects was limited and further development of ADG106 was reconsidered.
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Adagene (Suzhou) LimitedIndustry (pharma, biotech, devices)
- Study start
- 11 Mar 2021 (actual)
- Primary completion
- 9 Feb 2023 (actual)
- Study completion
- 9 Feb 2023 (actual)
- First posted
- 1 Mar 2021 (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 Multicenter, Open-Label, Phase Ib/II Study of ADG106 in Combination with PD-1 Antibody in Advanced Solid Tumors and Relapsed/Refractory Non-Hodgkin Lymphoma.
The primary objective of Phase Ib: To evaluate the maximum tolerated dosage (MTD) of ADG106 in combination with PD-1 antibody in advanced solid tumors and relapsed/refractory non-Hodgkin lymphoma, and to determine the recommended phase II clinical studies dosage (RP2D).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ADG106 combined with PD-1 antibody Dose Escalation Level 1 | Experimental | Biological: ADG106 injection, Biological: PD-1 antibody injection |
| ADG106 combined with anti PD-1 antibody Dose Escalation Level 2 | Experimental | Biological: ADG106 injection, Biological: PD-1 antibody injection |
| ADG106 combined with anti PD-1 antibody Expansion Phase | Experimental | Biological: ADG106 injection, Biological: PD-1 antibody injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with advanced solid tumors or relapses/refractory non-Hodgkin's lymphoma confirmed by histology or cytology
- Has at least one measurable lesion (solid tumor according to RECIST v1.1 criteria, non-Hodgkin's lymphoma according to Lugnao criteria)
- ECOG score of 0 or 1;
- Expected survival time ≥ 3 months (at the discretion of the investigator);
- Adequate organ and bone marrow function;
Key exclusion criteria (9 listed)
- Has central nervous system primary malignant tumor, active epileptic seizure, spinal cord compression or carcinomatous meningitis
- The previous anti-tumor treatment has not passed the prescribed washout period
- HIV antibody is positive, or with other acquired/congenital immunodeficiency disease, or with history of organ transplantation;
- Active hepatitis B or hepatitis C virus (HCV) antibody was positive;
- Patients who are pregnant or lactating;
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 |
|---|---|---|
| ADG106 injectionADG106 injection, intravenous infusion, is administered as body weight every 3 weeks for 21 days as a cycle | Biological | ADG106 combined with PD-1 antibody Dose Escalation Level 1, ADG106 combined with anti PD-1 antibody Dose Escalation Level 2, ADG106 combined with anti PD-1 antibody Expansion Phase |
| PD-1 antibody injectionPD-1 antibody injection is administered as an intravenous infusion and at a dose of 240mg every 3 weeks for 21 days as a cycle | Biological | ADG106 combined with PD-1 antibody Dose Escalation Level 1, ADG106 combined with anti PD-1 antibody Dose Escalation Level 2, ADG106 combined with anti PD-1 antibody Expansion Phase |
Primary outcome
Number of participants experiencing dosage limiting toxicity (DLT) in the first treatment cycle of the combination of ADG106 and PD-1 antibody.
Time frame: From first dose of ADG106 and PD-1 antibody (Week 1 Day 1) until 21 days
Objective response rate (ORR) of the combination of ADG106 and PD-1 antibody in advanced solid tumors and relapsed/refractory non-hodgkin lymphoma
Time frame: From baseline to measured progressive disease (up to 24 months)
6 secondary outcomes
Type of adverse event, incidence, grade (according to NCI CTCAE V 5.0 classification), onset time, and relationship to study treatment
Time frame: From the first dose of ADG106 and PD-1 antibody (Week 1 Day 1) to 28 days post last dose
Area under the time concentration curve(AUC) from time zero to infinity (AUC0-inf))
Time frame: From the first dose of ADG106 and PD-1 antibody (Cycle 1 Day 1,each cycle is 21 days) until the last dose (up to 2 years)
Maximum (peak) plasma concentration (Cmax)
Time frame: From the first dose of ADG106 and PD-1 antibody (Cycle 1 Day 1,each cycle is 21 days) until the last dose (up to 2 years)
Time to maximum(peak) plasma concentration Tmax
Time frame: From the first dose of ADG106 and PD-1 antibody (Cycle 1 Day 1,each cycle is 21 days) until the last dose (up to 2 years)
Through plasma concentration(Cthrough)
Time frame: From the first dose of ADG106 and PD-1 antibody (Cycle 1 Day 1,each cycle is 21 days) until the last dose (up to 2 years)
Anti-drug antibody levels of ADG106 and PD-1 antibody
Time frame: From the first dose of ADG106 and PD-1 antibody (Cycle 1 Day 1,each cycle is 21 days) until the last dose (up to 2 years)
Results and safety
The study was stopped early (reason given: The safety of ADG106 combined with triprilimab has been fully understood.The overall clinical benefit of enrolled subjects was limited and further development of ADG106 was reconsidered.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ADG106 injection and PD-1 antibody injection in people with Solid Tumor and Non Hodgkin Lymphoma, run by Adagene (Suzhou) Limited at 1 site in China.
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 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 24 Apr 2023. 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 China. 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 was stopped early (reason given: The safety of ADG106 combined with triprilimab has been fully understood.The overall clinical benefit of enrolled subjects was limited and further development of ADG106 was reconsidered.). 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 dosage limiting toxicity (DLT) in the first treatment cycle of the combination of ADG106 and PD-1 antibody. (time frame: From first dose of ADG106 and PD-1 antibody (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 24 Apr 2023.