NCT04775680
Terminated
Phase 1
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
Overview
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Adagene (Suzhou) Limited
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Objective response rate (ORR) of the combination of ADG106 and PD-1 antibody in advanced solid tumors and relapsed/refractory non-hodgkin lymphoma
Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
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)
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
Secondary Outcomes
- 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))
- 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))
- 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))
- 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))
Investigators
Study Sites (1)
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