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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04501276




Registration number
NCT04501276
Ethics application status
Date submitted
29/07/2020
Date registered
6/08/2020

Titles & IDs
Public title
A Phase 1b/2 Study of ADG116, ADG116 Combined With Anti-PD-1 Antibody or Anti-CD137 Antibody in Solid Tumors Patients
Scientific title
A Phase 1b/2, Open-Label, Dose Escalation and Expansion Study of ADG116, ADG116 Combined With Toripalimab (Anti-PD-1 Antibody), ADG116 Combined With ADG106 (Anti-CD137 Antibody) in Patients With Advanced/Metastatic Solid Tumors
Secondary ID [1] 0 0
ADG116-1003
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 - ADG116
Treatment: Drugs - ADG106
Treatment: Drugs - anti PD1 drug

Experimental: Part A : Dose escalation of ADG116 monotherapy -

Experimental: Part B : Dose escalation of ADG116 combined with anti PD1 drug -

Experimental: Part C : Dose escalation of ADG116 combined with ADG106 -


Treatment: Drugs: ADG116
For monotherapy ADG116 (Part A), ADG116 will be administered IV over 60 90 minutes until disease progression, intolerable toxicities, or withdrawal of consent, or up to 2 years.

Treatment: Drugs: ADG106
For the ADG116-ADG106 combination regimen, ADG116 and ADG106 will be administered until disease progression, intolerable toxicities, or withdrawal of consent, or up to 2 years.

Treatment: Drugs: anti PD1 drug
For the ADG116-anti PD1 combination regimen, ADG116 and anti PD1 will be administered 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 in adults with advanced / metastatic solid tumors
Timepoint [1] 0 0
From first dose of ADG116 (Week 1 Day 1) until 21 days
Primary outcome [2] 0 0
Number of participants with adverse events as assessed by CTCAE v5.0
Timepoint [2] 0 0
From first dose of ADG116 (Week 1 Day 1) to 28 days post last dose
Secondary outcome [1] 0 0
Area under the time concentration curve (AUC) from time zero to infinity (AUC0-inf)
Timepoint [1] 0 0
From first dose (Cycle 1 Day 1, ) until the last dose (up to 2 years)
Secondary outcome [2] 0 0
Maximum (peak) plasma concentration (Cmax)
Timepoint [2] 0 0
From first dose (Cycle 1 Day 1,) until the last dose (up to 2 years)
Secondary outcome [3] 0 0
Time to maximum (peak) plasma concentration (Tmax)
Timepoint [3] 0 0
From first dose (Cycle 1 Day 1,) until the last dose (up to 2 years)
Secondary outcome [4] 0 0
Trough plasma concentration (Ctrough)
Timepoint [4] 0 0
From first dose (Cycle 1 Day 1,) until the last dose (up to 2 years)
Secondary outcome [5] 0 0
Incidence of ADAs
Timepoint [5] 0 0
From first dose (Cycle 1 Day 1,) until the last dose (up to 2 years)
Secondary outcome [6] 0 0
Preliminary evidence of antitumor activity as characterized by objective response rate (ORR), disease control rate (DCR), duration of response (DOR), duration of stable disease, progression free survival (PFS), and overall survival (OS).
Timepoint [6] 0 0
From first dose of ADG116 (Week 1 Day 1) to 28 days post last dose

Eligibility
Key inclusion criteria
Patients must meet all of the following inclusion criteria to be eligible for participation in this study:

1. = 18 years of age at the time of informed consent.
2. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
3. Patients with advanced or metastatic solid tumors, who have progressed after all standard therapies, or for whom no further standard therapy exists.
4. At least 1 measurable lesion at baseline according to the definition of RECIST v1.1.
5. Adequate organ function.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients who meet any of the following criteria cannot be enrolled:

1. Pregnant or breastfeeding females.
2. Childbearing potential who does not agree to the use of contraception during the treatment period..
3. Treatment with any investigational drug within washout period.
4. Grade = 3 immune-related AEs (irAEs) or irAE that lead to discontinuation of prior immunotherapy.
5. Central nervous system disease involvement
6. History or risk of autoimmune disease.
7. History of life-threatening hypersensitivity or known to be allergic to protein drugs or recombinant proteins or any ingredients contained in the ADG116 drug formulation.
8. Patients requiring systemic treatment with corticosteroids
9. Patients receiving granulocyte colony stimulating factor (G-CSF), within 14 days prior to the first dose of the study drug.
10. Any uncontrolled active infections requiring systemic antimicrobial treatment (viral, bacterial, or other), or uncontrolled or poorly controlled, asthma, chronic obstructive pulmonary disease (COPD).
11. Major surgery within 4 weeks prior to the first dose of the study drug.
12. Has had an allogeneic tissue/solid organ transplant.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/09/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2025
Actual
Sample size
Target
Accrual to date
Final
72
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Ashford Cancer Centre Research - Kurralta Park
Recruitment hospital [2] 0 0
Cabrini Hospital - Malvern
Recruitment hospital [3] 0 0
Macquarie University - Sydney
Recruitment postcode(s) [1] 0 0
- Kurralta Park
Recruitment postcode(s) [2] 0 0
- Malvern
Recruitment postcode(s) [3] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Texas

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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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/NCT04501276