Non Hodgkin Lymphoma, Solid Tumor
Conditions
Keywords
Solid Tumor and Non Hodgkin Lymphoma
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).
Interventions
BIOLOGICALADG106 injection
ADG106 injection, intravenous infusion, is administered as body weight every 3 weeks for 21 days as a cycle
BIOLOGICALPD-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
Sponsors
Adagene (Suzhou) Limited
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| 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. | 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
| Measure | Time frame |
|---|---|
| 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 |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
Countries
China
Outcome results
None listed