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

NCT04775680 | Terminated Phase 1

• 1 other identifier: ADG106-1008
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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).

Conditions

Solid Tumor; Non Hodgkin Lymphoma

Keywords

Solid Tumor and Non Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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)

Study Arms (3)

ADG106 combined with PD-1 antibody Dose Escalation Level 1

EXPERIMENTAL

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

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

EXPERIMENTAL

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

ADG106 combined with anti PD-1 antibody Expansion Phase

EXPERIMENTAL

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

Interventions

ADG106 injection BIOLOGICAL

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

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

PD-1 antibody injection BIOLOGICAL

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

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Adagene (Suzhou) Limited: lead

Study Sites (1)

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2021
• First Posted: March 1, 2021
• Study Start: March 11, 2021
• Primary Completion: February 9, 2023
• Study Completion: February 9, 2023
• Last Updated: April 24, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)