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

Primary Purpose

Solid Tumor, Non Hodgkin Lymphoma

Status
Terminated
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
ADG106 injection
PD-1 antibody injection
Sponsored by
Adagene (Suzhou) Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Solid Tumor focused on measuring Solid Tumor and Non Hodgkin Lymphoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sun Yat-Sen University Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

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

Arm Description

Outcomes

Primary Outcome Measures

Number of participants experiencing dosage limiting toxicity (DLT) in the first treatment cycle of the combination of ADG106 and PD-1 antibody.
Objective response rate (ORR) of the combination of ADG106 and PD-1 antibody in advanced solid tumors and relapsed/refractory non-hodgkin lymphoma

Secondary Outcome Measures

Type of adverse event, incidence, grade (according to NCI CTCAE V 5.0 classification), onset time, and relationship to study treatment
Area under the time concentration curve(AUC) from time zero to infinity (AUC0-inf))
Maximum (peak) plasma concentration (Cmax)
Time to maximum(peak) plasma concentration Tmax
Through plasma concentration(Cthrough)
Anti-drug antibody levels of ADG106 and PD-1 antibody

Full Information

First Posted
February 16, 2021
Last Updated
April 20, 2023
Sponsor
Adagene (Suzhou) Limited
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1. Study Identification

Unique Protocol Identification Number
NCT04775680
Brief Title
Study of ADG106 In Combination With PD-1 Antibody In Advanced or Metastatic Solid Tumors and/or Non Hodgkin Lymphoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Terminated
Why 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.
Study Start Date
March 11, 2021 (Actual)
Primary Completion Date
February 9, 2023 (Actual)
Study Completion Date
February 9, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Adagene (Suzhou) Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 and relapsed/refractory non-Hodgkin lymphoma, and to determine the recommended phase II clinical studies dosage (RP2D).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumor, Non Hodgkin Lymphoma
Keywords
Solid Tumor and Non Hodgkin Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ADG106 combined with PD-1 antibody Dose Escalation Level 1
Arm Type
Experimental
Arm Title
ADG106 combined with anti PD-1 antibody Dose Escalation Level 2
Arm Type
Experimental
Arm Title
ADG106 combined with anti PD-1 antibody Expansion Phase
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
ADG106 injection
Intervention Description
ADG106 injection, intravenous infusion, is administered as body weight every 3 weeks for 21 days as a cycle
Intervention Type
Biological
Intervention Name(s)
PD-1 antibody injection
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Title
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)
Secondary Outcome Measure Information:
Title
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
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Sun Yat-Sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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