Status:
TERMINATED
Study of ADG106 In Combination With PD-1 Antibody In Advanced or Metastatic Solid Tumors and/or Non Hodgkin Lymphoma
Lead Sponsor:
Adagene (Suzhou) Limited
Conditions:
Solid Tumor
Non Hodgkin Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 9 2023
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04775680
Start Date
March 11 2021
End Date
February 9 2023
Last Update
April 24 2023
Active Locations (1)
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1
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China, 510000