Study of ADG106 In Combination With PD-1 Antibody In Advanced or Metastatic Solid Tumors and/or Non Hodgkin Lymphoma

April 20, 2023 updated by: Adagene (Suzhou) Limited

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Sun Yat-sen University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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;

Exclusion Criteria:

  • 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);
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ADG106 combined with PD-1 antibody Dose Escalation Level 1
Biological: ADG106 injection
ADG106 injection, intravenous infusion, is administered as body weight every 3 weeks for 21 days as a cycle
Biological: PD-1 antibody injection
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
Experimental: ADG106 combined with anti PD-1 antibody Dose Escalation Level 2
Biological: ADG106 injection
ADG106 injection, intravenous infusion, is administered as body weight every 3 weeks for 21 days as a cycle
Biological: PD-1 antibody injection
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
Experimental: ADG106 combined with anti PD-1 antibody Expansion Phase
Biological: ADG106 injection
ADG106 injection, intravenous infusion, is administered as body weight every 3 weeks for 21 days as a cycle
Biological: PD-1 antibody injection
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
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)
From baseline to measured progressive disease (up to 24 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
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)
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)
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)
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)
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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Adagene (Suzhou) Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 11, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 9, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 9, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 16, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 1, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ADG106-1008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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