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

Solid Tumor Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04775680
• Other study ID #: ADG106-1008
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: March 11, 2021
• Est. completion date: February 9, 2023

Study information

• Verified date: April 2023
• Source: Adagene Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: February 9, 2023
• Est. primary completion date: February 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non Hodgkin Lymphoma
• Solid Tumor

Intervention

Biological:
• ADG106 injection
ADG106 injection, intravenous infusion, is administered as body weight every 3 weeks for 21 days as a cycle
• 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

Locations

Country	Name	City	State
China	Sun Yat-Sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Adagene (Suzhou) Limited

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)