Study of ADG106 In Combination With PD-1 Antibody In Advanced or Metastatic Solid Tumors and/or Non Hodgkin Lymphoma
NCT ID: NCT04775680
Last Updated: 2023-04-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1/PHASE2
25 participants
INTERVENTIONAL
2021-03-11
2023-02-09
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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ADG106 combined with PD-1 antibody Dose Escalation Level 1
ADG106 injection
ADG106 injection, intravenous infusion, is administered as body weight every 3 weeks for 21 days as a cycle
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
ADG106 combined with anti PD-1 antibody Dose Escalation Level 2
ADG106 injection
ADG106 injection, intravenous infusion, is administered as body weight every 3 weeks for 21 days as a cycle
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
ADG106 combined with anti PD-1 antibody Expansion Phase
ADG106 injection
ADG106 injection, intravenous infusion, is administered as body weight every 3 weeks for 21 days as a cycle
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
Interventions
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ADG106 injection
ADG106 injection, intravenous infusion, is administered as body weight every 3 weeks for 21 days as a cycle
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Adagene (Suzhou) Limited
INDUSTRY
Responsible Party
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Locations
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Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
Countries
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Other Identifiers
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ADG106-1008
Identifier Type: -
Identifier Source: org_study_id
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