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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05614258




Registration number
NCT05614258
Ethics application status
Date submitted
27/10/2022
Date registered
14/11/2022
Date last updated
23/02/2023

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
N/A
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
1/12/2024
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
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05614258
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
Kristine_she@adagene.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05614258