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

Study 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).

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

Conditions
-----------------
Solid Tumor, Non Hodgkin Lymphoma

Intervention / Treatment
-----------------
* Biological: ADG106 injection
* Biological: PD-1 antibody injection


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ADG106 combined with PD-1 antibody Dose Escalation Level 1<br> | Biological: ADG106 injection<br>* ADG106 injection, intravenous infusion, is administered as body weight every 3 weeks for 21 days as a cycle<br>Biological: PD-1 antibody injection<br>* 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<br>|
| Experimental: ADG106 combined with anti PD-1 antibody Dose Escalation Level 2<br> | Biological: ADG106 injection<br>* ADG106 injection, intravenous infusion, is administered as body weight every 3 weeks for 21 days as a cycle<br>Biological: PD-1 antibody injection<br>* 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<br>|
| Experimental: ADG106 combined with anti PD-1 antibody Expansion Phase<br> | Biological: ADG106 injection<br>* ADG106 injection, intravenous infusion, is administered as body weight every 3 weeks for 21 days as a cycle<br>Biological: PD-1 antibody injection<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 
| 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Solid Tumor and Non Hodgkin Lymphoma