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

Phase 1

Terminated

• Conditions: Non Hodgkin Lymphoma; Solid Tumor
• Interventions: Biological: ADG106 injection; Biological: PD-1 antibody injection

• Registration Number: NCT04775680
• Lead Sponsor: Adagene (Suzhou) Limited

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-16
• Study First Submitted QC: 2021-02-25
• Study First Posted: 2021-03-01
• Study Start: 2021-03-11
• Primary Completion: 2023-02-09
• Study Completion: 2023-02-09
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-20
• Last Update Posted: 2023-04-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
ADG106 combined with anti PD-1 antibody Expansion Phase	PD-1 antibody injection	-
ADG106 combined with PD-1 antibody Dose Escalation Level 1	ADG106 injection	-
ADG106 combined with PD-1 antibody Dose Escalation Level 1	PD-1 antibody injection	-
ADG106 combined with anti PD-1 antibody Expansion Phase	ADG106 injection	-
ADG106 combined with anti PD-1 antibody Dose Escalation Level 2	ADG106 injection	-
ADG106 combined with anti PD-1 antibody Dose Escalation Level 2	PD-1 antibody injection	-

Primary Outcome Measures

Name	Time	Method
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)
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

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Sun Yat-Sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China