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

Adagene

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Solid Tumor; Non Hodgkin Lymphoma

Treatments: Biological: PD-1 antibody injection; Biological: ADG106 injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT04775680

ADG106-1008

Details and patient eligibility

About

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).

Enrollment: 25 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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25 participants in 3 patient groups

ADG106 combined with PD-1 antibody Dose Escalation Level 1

Experimental group

Treatment:

Biological: PD-1 antibody injection

Biological: ADG106 injection

ADG106 combined with anti PD-1 antibody Dose Escalation Level 2

Experimental group

Treatment:

Biological: PD-1 antibody injection

Biological: ADG106 injection

ADG106 combined with anti PD-1 antibody Expansion Phase

Experimental group

Treatment:

Biological: PD-1 antibody injection

Biological: ADG106 injection