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Solid TumorPhase 1NCT03802955

Study of ADG106 With Advanced or Metastatic Solid Tumors and/or Non-Hodgkin Lymphoma

A Phase 1 study testing ADG106 in people with Solid Tumor and Non-Hodgkin Lymphoma, run by Adagene (Suzhou) Limited at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Phase 1, open-label, dose-escalation, single-center study of ADG106 in subjects with advanced or metastatic solid tumors and/or relapsed/ refractory non-Hodgkin lymphoma. ADG106 is a fully human ligand-blocking, agonistic anti-CD137 IgG4 mAb. 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
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
2 sitesChina
Study dates
20 Dec 2018to 1 Nov 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 years to 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 and/or non-Hodgkin lymphoma who are refractory or relapsed from standard therapy and who have exhausted all available therapies.
  • At least one measurable lesion per RECIST 1.1 for solid tumors and per Lugano Classification for non-Hodgkin lymphoma
  • ECOG performance: 0-1
  • Adequate organ and bone marrow function
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  • After receiving the last treatment (chemotherapy, radiotherapy, biotherapy or other research drugs), the patient had a washout period of at least 4 weeks or more than 5 half-lives, and had recovered from any toxic reaction of the previous treatment to less than 1 degree.
  • No other concomitant antineoplastic therapy (including cell therapy)
  • Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within the 7 days prior to study drug administration.
  • Coagulation function is basically normal, INR≤1.5
  • Cooperative in observation of adverse events and efficacy

Who cannot join

  • Subjects with positive HCV antibody，or active hepatitis B (HBV DNA ≥ 10000 copies/mL or 2000 IU/mL), or positive hepatitis virus and taking antiviral drugs
  • Subjects with meningeal metastasis, or subjects with brain metastasis lesions ≥ 1 cm and untreated, or subjects with brain metastasis requiring mannitol or other dehydration therapy
  • Infection of human immunodeficiency virus (HIV), or suffering from other acquired, congenital immunodeficiency disorders, or organ transplantation history
  • Any active autoimmune disease or evidence-based autoimmune disease, or systemic syndrome requiring systemic steroids or immunosuppressive drugs (Except for inactive vitiligo, psoriasis, asthma/specific reactivity in children after treatment within two years, or thyroid diseases controlled by alternative therapy/non-immunosuppressive therapy）
  • The residual toxicity of the patient's previous treatment was more than grade 1
  • Fever body temperature above 38℃ or there are clinically obvious active infections that can affect clinical trials
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  • Overdose of glucocorticoid (>10mg/d prednisone or equivalent dose) or other immunosuppressive agents was used within one month
  • According to the investigator, any uncontrollable serious clinical problems include but are not limited to, evidence of severe or uncontrollable systemic diseases (such as unstable or uncompensated respiratory, cardiac, liver or kidney diseases); and any unstable systemic diseases (including active infections, refractory high or drug failure Controlled hypertension (>150/100 mmHg), unstable angina pectoris, congestive heart failure, liver and kidney or metabolic diseases）
  • A clear history of neurological or psychiatric disorders, including epilepsy or dementia
  • Non-research-related surgical procedures performed prior to the use of research drugs in patients within 28 days
  • Investigator do not consider he/she appropriate to participate in this study
  • Pregnant or lactating women

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510000

  • Shanghai Dongfang Hospital

    Shanghai, Shanghai Municipality, 200120

Other trials in China

About this study

Official title: A Phase Ⅰ Study of ADG106 Administered in Patients With Advanced or Metastatic Solid Tumors and/or Non-Hodgkin Lymphoma

This is a Phase 1, open-label, dose-escalation, single-center study of ADG106 in subjects with advanced or metastatic solid tumors and/or relapsed/ refractory non-Hodgkin lymphoma. ADG106 is a fully human ligand-blocking, agonistic anti-CD137 IgG4 mAb. It binds to the activated human T cells via a T cell receptor CD137. ADG106 administered intravenously (IV) over a period of 60-90 minutes.

Primary objective:

Read more

To assess safety and tolerability at increasing dose levels of single agent ADG106 in subjects with advanced or metastatic solid tumors and/or non Hodgkin lymphoma.

To determine the recommended dosage and dosage regimen for further study. Secondary Objectives To characterize the pharmacokinetic (PK) profiles of ADG106. To evaluate the immunogenicity of ADG106. To evaluate the potential anti-tumor effect of ADG106. To investigate serum biomarkers related to immune regulation and cytokine releasing.

Exploratory Objective:

To identify the potential biomarkers of ADG106.

Being tested
ADG106
Keywords
Solid Tumor, 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.

  • ADG106Drug

    IV infusion over 60 minutes on Day 1 of each cycle, at 7 doses depending on cohort at enrollment.

Study groups in NCT03802955
Study groupRoleWhat they receive
ADG106 Dose escalationExperimentalNot described
Receives: Drug: ADG106

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. DLTs in the first 2 cycles of single drug administration

    Measured: 2 Cycles (42 days)

Secondary outcomes (17)

  1. Number of clinical and laboratory adverse events (AEs) .

    Measured: First dose to 30 days post last dose

  2. Objective response rate (ORR) as assessed by RECIST version 1.1 and immune-related RECIST (irRECIST) for solid tumor and the Lugano Classification for non-Hodgkin Lymphoma

    Measured: 2 Cycles (42 days)

  3. Duration of response (DOR) as assessed by RECIST version 1.1 and immune-related RECIST (irRECIST) for solid tumor and the Lugano Classification for non-Hodgkin Lymphoma

    Measured: 2 Cycles (42 days)

  4. Time to progression (TTP) as assessed by RECIST version 1.1 and immune-related RECIST (irRECIST) for solid tumor and the Lugano Classification for non-Hodgkin Lymphoma

    Measured: 2 Cycles (42 days)

  5. Disease control rate (DCR) as assessed by RECIST version 1.1 and immune-related RECIST (irRECIST) for solid tumor and the Lugano Classification for non-Hodgkin Lymphoma

    Measured: 2 Cycles (42 days)

  6. Progression-free survival (PFS) as assessed by RECIST version 1.1 and immune-related RECIST (irRECIST) for solid tumor and the Lugano Classification for non-Hodgkin Lymphoma

    Measured: 2 Cycles (42 days)

  7. Peak plasma concentration (Cmax)

    Measured: 2 Cycles (42 days)

  8. Plasma concentration at the end of a dosing interval (Ctrough)

    Measured: 2 Cycles (42 days)

  9. Time to reach Cmax (Tmax)

    Measured: 2 Cycles (42 days)

  10. Area under the curve from time zero to the last timepoint (AUC0-last)

    Measured: 2 Cycles (42 days)

  11. AUC from time zero to infinity (AUC0-∞)

    Measured: 2 Cycles (42 days)

  12. AUC during a dosing interval (AUCtau)

    Measured: 2 Cycles (42 days)

  13. Clearance (CL)

    Measured: 2 Cycles (42 days)

  14. Volume of distribution at steady state (Vss)

    Measured: 2 Cycles (42 days)

  15. ADA levels for ADG106.

    Measured: 2 Cycles (42 days)

  16. Serum biomarkers linked to immunomodulation and cytokine release: such as TNFα, IFN-γ, IL 10, IL-6, IL-4, IL-2.

    Measured: 2 Cycles (42 days)

  17. Cell counts for circulating T, natural killer (NK), and B cells.

    Measured: 2 Cycles (42 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2019
  2. Study start20 Dec 2018
  3. Primary completion1 Nov 2021
  4. Study completion1 Nov 2021

Resources

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
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03802955
Sponsor's protocol ID
ADG106-1002
Status last verified
Apr 2023
First submitted
8 Jan 2019
Last updated
24 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ma Y, Luo F, Zhang Y, Liu Q, Xue J, Huang Y, Zhao Y, Yang Y, Fang W, Zhou T, Chen G, Cao J, Chen Q, She X, Luo P, Liu G, Zhang L, Zhao H. Preclinical characterization and phase 1 results of ADG106 in patients with advanced solid tumors and non-Hodgkin's lymphoma. Cell Rep Med. 2024 Feb 20;5(2):101414. doi: 10.1016/j.xcrm.2024.101414. Epub 2024 Feb 7.

    PubMed 38330942

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ADG106 in people with Solid Tumor and Non-Hodgkin Lymphoma, run by Adagene (Suzhou) Limited at 2 sites 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 11 inclusion and 12 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 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 2 sites 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 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?

DLTs in the first 2 cycles of single drug administration (time frame: 2 Cycles (42 days)). 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 NCT03802955, which also lists 2 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 24 Apr 2023.

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