Register a trial

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05614258




Registration number
NCT05614258
Ethics application status
Date submitted
27/10/2022
Date registered
14/11/2022

Titles & IDs
Public title
Study of ADG206 in Subjects With Advanced/Metastatic Solid Tumors
Scientific title
A First-in-Human (FIH), Open-Label, Phase 1 Study of ADG206, a CD137 Agonist Antibody, in Subjects With Advanced/Metastatic Solid Tumors
Secondary ID [1] 0 0
ADG206-1001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced/Metastatic Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ADG206

Experimental: ADG206 dose escalation -


Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants experiencing dose-limiting toxicities escalating dose levels
Timepoint [1] 0 0
At the end of Cycle 1 (each cycle is 21 days)
Primary outcome [2] 0 0
Number of participants with adverse events (AE)
Timepoint [2] 0 0
At the end of 90 days post last dose (each cycle is 21 days)
Primary outcome [3] 0 0
Maximum administered dose (MAD) of ADG206
Timepoint [3] 0 0
At the end of the last dose (each cycle is 21 days)
Primary outcome [4] 0 0
Maximum tolerated dose (MTD) of ADG 206
Timepoint [4] 0 0
At the end of the last dose (each cycle is 21 days)
Primary outcome [5] 0 0
Recommended Phase 2 dose (RP2D) of ADG206
Timepoint [5] 0 0
At the end of the last dose (each cycle is 21 days)
Secondary outcome [1] 0 0
The area under the curve (AUC) of plasma concentration of drug
Timepoint [1] 0 0
At the end of the last dose (each cycle is 21 days)
Secondary outcome [2] 0 0
Immunogenicity endpoints include antidrug antibodies (ADAs)
Timepoint [2] 0 0
At the end of the last dose (each cycle is 21 days)
Secondary outcome [3] 0 0
Maximum concentration (Cmax)
Timepoint [3] 0 0
At the end of the last dose (each cycle is 21 days)
Secondary outcome [4] 0 0
Time to maximum plasma concentration (Tmax)
Timepoint [4] 0 0
At the end of the last dose (each cycle is 21 days)
Secondary outcome [5] 0 0
Lowest plasma concentration (C[trough])
Timepoint [5] 0 0
At the end of the last dose (each cycle is 21 days)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/02/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2025
Actual
Sample size
Target
21
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Ashford Cancer Centre Research - Kurralta Park
Recruitment hospital [2] 0 0
Monash Health - Clayton
Recruitment postcode(s) [1] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [2] 0 0
3168 - Clayton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Adagene Inc
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Xiaohong She
Address 0 0
Country 0 0
Phone 0 0
4088389296
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05614258