Save

Study of ADG206 in Subjects With Advanced/Metastatic Solid Tumors

PHASE1RECRUITING

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.

Simpliy with AI

Study details:

This is a FIH, Phase 1, open-label, multicenter, sequential dose escalation study to evaluate the safety, tolerability, Pharmacokinetics (PK), and preliminary efficacy of ADG206 in subjects with advanced/metastatic malignancies. Primary Objective of the study: To assess safety and tolerability at increasing dose levels of ADG206 in subjects with advanced/metastatic solid tumors who have exhausted their treatment alternatives.

Simplify with AI

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

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.

Exclusion criteria

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.

Known hypersensitivity, allergies, or intolerance to immunoglobulins or to any excipient contained in ADG206.

Pregnant, lactating, or breastfeeding.

Simplify with AI

Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2023-02-13

Primary completion: 2025-05-01

Study completion finish: 2025-10-01

Study type

TREATMENT

Phase

PHASE1

Trial ID

NCT05614258

Intervention or treatment

DRUG: ADG206

Conditions

• Advanced/Metastatic Solid Tumors

Image related to Advanced/Metastatic Solid Tumors

Condition: Advanced/Metastatic Solid Tumors
DRUG: ADG206
Clayton, Victoria, Australia and more
Sponsor: Adagene Inc

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Monash Health

Research sites nearby

Select from list below to view details:

Monash Health
Clayton, Victoria, Australia
Ashford Cancer Centre Research
Kurralta Park, South Australia, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: ADG206 dose escalation Not Specified	DRUG: ADG206 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.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Number of participants experiencing dose-limiting toxicities escalating dose levels	Not Specified	At the end of Cycle 1 (each cycle is 21 days)
Number of participants with adverse events (AE)	Not Specified	At the end of 90 days post last dose (each cycle is 21 days)
Maximum administered dose (MAD) of ADG206	Not Specified	At the end of the last dose (each cycle is 21 days)
Maximum tolerated dose (MTD) of ADG 206	Not Specified	At the end of the last dose (each cycle is 21 days)
Recommended Phase 2 dose (RP2D) of ADG206	Not Specified	At the end of the last dose (each cycle is 21 days)

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
The area under the curve (AUC) of plasma concentration of drug	Not Specified	At the end of the last dose (each cycle is 21 days)
Immunogenicity endpoints include antidrug antibodies (ADAs)	Not Specified	At the end of the last dose (each cycle is 21 days)
Maximum concentration (Cmax)	Not Specified	At the end of the last dose (each cycle is 21 days)
Time to maximum plasma concentration (Tmax)	Not Specified	At the end of the last dose (each cycle is 21 days)
Lowest plasma concentration (C[trough])	Not Specified	At the end of the last dose (each cycle is 21 days)

Frequently Asked Questions

Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol

No questions submitted. Be the first to ask a question!

You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: Study of ADG206 in Subjects With Advanced/Metastatic Solid Tumors