Study of ADG106 In Combination With PD-1 Antibody In Advanced or Metastatic Solid Tumors and/or Non Hodgkin Lymphoma
Study Details
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).
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1/Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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
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. [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 [From baseline to measured progressive disease (up to 24 months)]
Secondary Outcome Measures
- Type of adverse event, incidence, grade (according to NCI CTCAE V 5.0 classification), onset time, and relationship to study treatment [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)) [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) [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 [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) [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 [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
Criteria
Inclusion Criteria:
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Patients with advanced solid tumors or relapses/refractory non-Hodgkin's lymphoma confirmed by histology or cytology
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Has at least one measurable lesion (solid tumor according to RECIST v1.1 criteria, non-Hodgkin's lymphoma according to Lugnao criteria)
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ECOG score of 0 or 1;
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Expected survival time ≥ 3 months (at the discretion of the investigator);
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Adequate organ and bone marrow function;
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Voluntarily sign the informed consent form;
Exclusion Criteria:
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Has central nervous system primary malignant tumor, active epileptic seizure, spinal cord compression or carcinomatous meningitis
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The previous anti-tumor treatment has not passed the prescribed washout period
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HIV antibody is positive, or with other acquired/congenital immunodeficiency disease, or with history of organ transplantation;
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Active hepatitis B or hepatitis C virus (HCV) antibody was positive;
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Patients who are pregnant or lactating;
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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);
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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);
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Participation in another therapeutic or interventional clinical study in the meantime;
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Other circumstances where the investigator considers it is not appropriate to participate in the study.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Sun Yat-Sen University Cancer Center | Guangzhou | Guangdong | China | 510000 |
Sponsors and Collaborators
- Adagene (Suzhou) Limited
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ADG106-1008