Study of ADG206 in Subjects With Advanced/Metastatic Solid Tumors

NCT05614258 | Active Not Recruiting Phase 1

• 1 other identifier: ADG206-1001
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

Brief Summary

ADG206 is an activatable prodrug form of a fully human monoclonal antibody (mAb) of the immunoglobulin G1 (IgG1) subclass that specifically targets cluster of differentiation 137 (CD137) (also known as 4-1BB) as a co-stimulatory receptor agonist for the treatment of advanced malignancies.

Conditions

Advanced/Metastatic Solid Tumors

Outcome Measures

Primary Outcomes (5)

• Number of participants experiencing dose-limiting toxicities escalating dose levels

  At the end of Cycle 1 (each cycle is 21 days)

• Number of participants with adverse events (AE)

  At the end of 90 days post last dose (each cycle is 21 days)

• Maximum administered dose (MAD) of ADG206

  At the end of the last dose (each cycle is 21 days)

• Maximum tolerated dose (MTD) of ADG 206

  At the end of the last dose (each cycle is 21 days)

• Recommended Phase 2 dose (RP2D) of ADG206

  At the end of the last dose (each cycle is 21 days)

Secondary Outcomes (5)

• The area under the curve (AUC) of plasma concentration of drug

  At the end of the last dose (each cycle is 21 days)

• Immunogenicity endpoints include antidrug antibodies (ADAs)

  At the end of the last dose (each cycle is 21 days)

• Maximum concentration (Cmax)

  At the end of the last dose (each cycle is 21 days)

• Time to maximum plasma concentration (Tmax)

  At the end of the last dose (each cycle is 21 days)

• Lowest plasma concentration (C[trough])

  At the end of the last dose (each cycle is 21 days)

Study Arms (1)

ADG206 dose escalation

EXPERIMENTAL

Drug: ADG206

Interventions

ADG206 DRUG

All participants in this study will receive the study drug ADG206 in one of the designed dosage level. ADG206 will be administered by intravenous infusion over 60-90 minutes on Day 1 of each treatment cycle until disease progression, intolerable toxicities or withdrawal of consent, or up to 2 years.

ADG206 dose escalation

Eligibility Criteria

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

You may qualify if:

• Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
• Subjects with advanced or metastatic solid tumors (except thymic tumors), which have progressed after all standard therapies, or no further standard therapies exists.
• At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
• Adequate organ function.
• Woman of childbearing potential must agree to use 2 methods of acceptable contraception from screening until 6 months after the last dose of study drug.
• Male subjects who are sexually active with a female partner of childbearing potential must agree to use a barrier contraception.

You may not qualify if:

• Subjects within washout period of other anti-tumor therapies. .
• History of prior malignancy other than the cancer under treatment in the study.
• Major trauma or major surgery within 4 weeks before the first dose of study drug.
• Serious nonhealing wound, ulcer, or bone fracture.
• History of significant immune-mediated AE.
• Central nervous system (CNS) disease involvement.
• Any evidence of underlying severe liver dysfunction.
• Prior organ allograft transplantations or allogeneic bone marrow, cord blood or peripheral blood stem cell transplantation.
• Clinically significant cardiac disease with insufficient cardiac function.
• Evidence of active uncontrolled viral, bacterial, or systemic fungal infection.
• Known positive test result for human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS).
• Infection of hepatitis B virus (HBV), or hepatitis C virus (HCV) (unless the disease is clinically controlled) .
• History or risk of autoimmune disease.
• Subjects with active severe lung infection or with a history of interstitial lung diseases, noninfectious pneumonitis, active pulmonary tuberculosis, or evidence of active pneumonitis. Clinically significant and unmanageable ascites defined as requiring constant therapeutic paracentesis.
• Any serious underlying issue that would limit compliance with study requirements, impair the ability of the subject to understand informed consent.

Sponsors & Collaborators

• Adagene Inc: lead

Study Sites (2)

Ashford Cancer Centre Research

Kurralta Park, South Australia, 5037, Australia

Location

Monash Health

Clayton, Victoria, 3168, Australia

Location

Study Design

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

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: November 14, 2022
• Study Start: February 13, 2023
• Primary Completion: June 25, 2025
• Study Completion (Estimated): August 30, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)