Clinical trial
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
Name
ADG106-1008
Description
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).
Trial arms
Trial start
2021-03-11
Estimated PCD
2023-02-09
Trial end
2023-02-09
Status
Terminated
Phase
Early phase I
Treatment
ADG106 injection
ADG106 injection, intravenous infusion, is administered as body weight every 3 weeks for 21 days as a cycle
Arms:
ADG106 combined with PD-1 antibody Dose Escalation Level 1, ADG106 combined with anti PD-1 antibody Dose Escalation Level 2, ADG106 combined with anti PD-1 antibody Expansion Phase
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
Arms:
ADG106 combined with PD-1 antibody Dose Escalation Level 1, ADG106 combined with anti PD-1 antibody Dose Escalation Level 2, ADG106 combined with anti PD-1 antibody Expansion Phase
Size
25
Primary endpoint
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)
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 25, 'type': 'ACTUAL'}}
Updated at
2023-04-24
1 organization
2 products
2 indications
Organization
AdageneProduct
ADG106Indication
Solid TumorIndication
Non-Hodgkin LymphomaProduct
PD-1 antibody