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

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ClinicalTrials.gov Identifier: NCT04775680
Recruitment Status : Recruiting
First Posted : March 1, 2021
Last Update Posted : January 12, 2022
Sponsor:
Information provided by (Responsible Party):
Adagene Inc ( Adagene (Suzhou) Limited )

Study Description
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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).


Condition or disease Intervention/treatment Phase
Solid Tumor Non Hodgkin Lymphoma Biological: ADG106 injection Biological: PD-1 antibody injection Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 11, 2021
Estimated Primary Completion Date : July 15, 2023
Estimated Study Completion Date : February 28, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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 Measures :
  1. 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 ]
  2. 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) ]
  3. 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) ]
  4. 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) ]
  5. 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) ]
  6. 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) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04775680


Contacts
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Contact: Xiaohong She 1-408-838-9296 kristine_she@adagene.com

Locations
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China, Guangdong
Sun Yat-Sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Li Zhang         
Sponsors and Collaborators
Adagene (Suzhou) Limited
More Information
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Responsible Party: Adagene (Suzhou) Limited
ClinicalTrials.gov Identifier: NCT04775680    
Other Study ID Numbers: ADG106-1008
First Posted: March 1, 2021    Key Record Dates
Last Update Posted: January 12, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Adagene Inc ( Adagene (Suzhou) Limited ):
Solid Tumor and Non Hodgkin Lymphoma
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Antibodies
Immunologic Factors
Physiological Effects of Drugs