Trial Review

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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/NCT04645069




Registration number
NCT04645069
Ethics application status
Date submitted
20/11/2020
Date registered
27/11/2020
Date last updated
24/02/2023

Titles & IDs
Public title
ADG126, ADG126 in Combination With Anti PD1 Antibody, and ADG126 in Combination With ADG106 in Advanced/Metastatic Solid Tumors
Scientific title
A First-in-Human (FIH), Open-Label, Phase 1/2 Dose Escalation and Expansion Study of ADG126, ADG126 in Combination With Anti PD1 Antibody, and ADG126 in Combination With ADG106 in Patients With Advanced/Metastatic Solid Tumors
Secondary ID [1] 0 0
ADG126-1001
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
Other interventions - ADG126 Mono
Other interventions - ADG126-anti PD1
Other interventions - ADG126-ADG106

Experimental: ADG126 mono dose escalation - ADG126 monotherapy dose escalation will be traditional 3+3 cohort design.

Experimental: ADG126 mono dose expansion - Monotherapy dose expansion is designed to evaluate the preliminary antitumor activity of ADG126 at RP2D or the doses approved by the SRC.

Experimental: ADG126-anti PD1 drug dose escalation - Combination therapy will commence at a dose level lower than the cleared dose from the monotherapy dose escalation arms and approved by the SRC.

Experimental: ADG126-anti PD1 drug dose expansion - Combination therapy expansion will commence at RP2D or the dose approved by the SRC.

Experimental: ADG126-ADG106 dose escalation - Combination therapy will commence at a dose level lower than the cleared dose from the monotherapy dose escalation arms and approved by the SRC.

Experimental: ADG126-ADG106 dose expansion - Combination therapy expansion will commence at RP2D or the dose approved by the SRC.


Other interventions: ADG126 Mono
ADG126 will be administered as an IV infusion over 30-60 minutes ± 15 minutes.

Other interventions: ADG126-anti PD1
ADG126-toripalimab combination regimen will receive of toripalimab 15 to 30 minutes after the end of the ADG126 infusion

Other interventions: ADG126-ADG106
ADG126-ADG106 combination regimen will be receive of ADG106 15 to 30 minutes after the end of the ADG126 infusion
Intervention code [1] 0 0
Other interventions
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 ADG126 (Week 1 Day 1) until 21 days
Primary outcome [2] 0 0
Number of participants with adverse events as assessed by CTCAE v5.0 ADG126-ADG106 combination regimens
Timepoint [2] 0 0
From first dose of ADG126 (Week 1 Day 1) to 90 days post last dose
Secondary outcome [1] 0 0
Antidrug antibodies (ADAs)
Timepoint [1] 0 0
From first dose (Cycle 1 Day 1, ) until the last dose (up to 2 years)
Secondary outcome [2] 0 0
Area under the time concentration curve (AUC) from time zero to infinity (AUC0-inf)
Timepoint [2] 0 0
From first dose (Cycle 1 Day 1, ) until the last dose (up to 2 years)
Secondary outcome [3] 0 0
Maximum (peak) plasma concentration (Cmax)
Timepoint [3] 0 0
From first dose (Cycle 1 Day 1, ) until the last dose (up to 2 years)
Secondary outcome [4] 0 0
Time to maximum (peak) plasma concentration (Tmax)
Timepoint [4] 0 0
From first dose (Cycle 1 Day 1, ) until the last dose (up to 2 years)
Secondary outcome [5] 0 0
Trough plasma concentration (Ctrough)
Timepoint [5] 0 0
From first dose (Cycle 1 Day 1, ) until the last dose (up to 2 years)

Eligibility
Key inclusion criteria
Inclusion criteria

1. Adults =18 years of age.

2. ECOG performance status 0 or 1.

3. Estimated life expectancy of more than 12 weeks .

4. Patients with advanced or metastatic solid tumors, confirmed by histologically or
pathologically documented, who have progressed after all standard therapies, or for
whom no further standard therapy exists.

5. At least 1 measurable lesion at baseline according to the definition of RECIST v1.1.

6. Adequate organ function.

7. Meets the additional tumor type requirements as specified in Protocol.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Treatment with any investigational drug within washout period.

2. Major trauma or major surgery within 4 weeks prior to first dose of study drug(s)

3. History of significant immune-mediated AE.

4. Central nervous system (CNS) disease involvement.

5. Prior organ allograft transplantations or allogeneic peripheral blood stem cell
(PBSC)/bone marrow (BM) transplantation

6. Clinically significant cardiac disease.

7. Evidence of active uncontrolled viral, bacterial, or systemic fungal infection.

8. Patients who received:

1. A COVID-19 vaccine within 7 days of Cycle 1 Day 1.

2. Live vaccines or live-attenuated vaccines within 28 days prior to Cycle 1 Day 1.

9. Known active infection of HBV/BCV/HIV.

10. Patients requiring systemic treatment with corticosteroids or other immunosuppressive
medications (>10 mg/day prednisone or equivalent).

11. Second primary malignancy not in remission for greater than 3 years.

12. History(within the last 5 years) or risk of autoimmune disease.

13. Pregnant or breastfeeding females.

14. Childbearing potential who does not agree to the use of contraception during the
treatment period.

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/Phase 2
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
15/03/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
91
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Southside Cancer Care Centre - Miranda
Recruitment hospital [2] 0 0
Macquarie University Hospital - Sydney
Recruitment hospital [3] 0 0
Sunshine Coast University Private Hospital - Birtinya
Recruitment hospital [4] 0 0
Cabrini Health Limited - Malvern
Recruitment hospital [5] 0 0
One Clinical Research Pty Ltd - Nedlands
Recruitment postcode(s) [1] 0 0
2228 - Miranda
Recruitment postcode(s) [2] 0 0
- Sydney
Recruitment postcode(s) [3] 0 0
4575 - Birtinya
Recruitment postcode(s) [4] 0 0
3144 - Malvern
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Texas
Country [3] 0 0
Singapore
State/province [3] 0 0
Singapore

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

Ethics approval
Ethics application status

Summary
Brief summary
ADG126, ADG126 in Combination with anti-PD1 antibody, and ADG126 in Combination with ADG106
in Patients with Advanced/Metastatic Solid Tumors .
Trial website
https://clinicaltrials.gov/ct2/show/NCT04645069
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/NCT04645069