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

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

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).

Study Overview

• Status: Terminated
• Conditions: Solid Tumor; Non Hodgkin Lymphoma
• Intervention / Treatment: Biological: ADG106 injection; Biological: PD-1 antibody injection

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Xiaohong She; Phone Number: 1-408-838-9296; Email: kristine_she@adagene.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Sun Yat-sen University Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ADG106 combined with PD-1 antibody Dose Escalation Level 1	Biological: ADG106 injection; ADG106 injection, intravenous infusion, is administered as body weight every 3 weeks for 21 days as a cycle; Biological: 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
Experimental: ADG106 combined with anti PD-1 antibody Dose Escalation Level 2	Biological: ADG106 injection; ADG106 injection, intravenous infusion, is administered as body weight every 3 weeks for 21 days as a cycle; Biological: 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
Experimental: ADG106 combined with anti PD-1 antibody Expansion Phase	Biological: ADG106 injection; ADG106 injection, intravenous infusion, is administered as body weight every 3 weeks for 21 days as a cycle; Biological: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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)

Secondary Outcome Measures

Outcome Measure	Time Frame
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
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Adagene (Suzhou) Limited

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2021
• Primary Completion (Actual): February 9, 2023
• Study Completion (Actual): February 9, 2023

Study Registration Dates

• First Submitted: February 16, 2021
• First Submitted That Met QC Criteria: February 25, 2021
• First Posted (Actual): March 1, 2021

Study Record Updates

• Last Update Posted (Actual): April 24, 2023
• Last Update Submitted That Met QC Criteria: April 20, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Solid Tumor and Non Hodgkin Lymphoma
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Lymphoma, Non-Hodgkin; Physiological Effects of Drugs; Immunologic Factors; Antibodies
• Other Study ID Numbers: ADG106-1008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No