Advanced/Metastatic Solid Tumors
Conditions
Keywords
Advanced/Metastatic Solid Tumors
Brief summary
ADG126, ADG126 in Combination with anti-PD1 antibody, and ADG126 in Combination with ADG106 in Patients with Advanced/Metastatic Solid Tumors .
Detailed description
ADG126 is a novel anti-CTLA-4 fully human IgG1 antibody prodrug that is modified with Adagene Safebody technology to control the activation of anti-CTLA4 activity.ADG106 is a fully human ligand-blocking, agonistic anti-CD137 IgG4 mAb which is expected to enhance the activity of activated T cells. The enhanced antitumor efficacy results observed from the preclinical studies of ADG126 in combination with ADG106 or anti-PD-1 provided further support to explore such combinations in clinical settings for better patient responses.
Interventions
BIOLOGICALADG126 Mono
ADG126 will be administered as an IV infusion over 30-60 minutes ± 15 minutes.
BIOLOGICALADG126-anti PD1
ADG126-toripalimab combination regimen will receive of toripalimab 15 to 30 minutes after the end of the ADG126 infusion
BIOLOGICALADG126-ADG106
ADG126-ADG106 combination regimen will be receive of ADG106 15 to 30 minutes after the end of the ADG126 infusion
Sponsors
Adagene Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants experiencing dose-limiting toxicities escalating dose levels in adults with advanced / metastatic solid tumors | From first dose of ADG126 (Week 1 Day 1) until 21 days |
| Number of participants with adverse events as assessed by CTCAE v5.0 ADG126-ADG106 combination regimens | From first dose of ADG126 (Week 1 Day 1) to 90 days post last dose |
Secondary
| Measure | Time frame |
|---|---|
| Antidrug antibodies (ADAs) | From first dose (Cycle 1 Day 1, ) until the last dose (up to 2 years) |
| Area under the time concentration curve (AUC) from time zero to infinity (AUC0-inf) | From first dose (Cycle 1 Day 1, ) until the last dose (up to 2 years) |
| Maximum (peak) plasma concentration (Cmax) | From first dose (Cycle 1 Day 1, ) until the last dose (up to 2 years) |
| Time to maximum (peak) plasma concentration (Tmax) | From first dose (Cycle 1 Day 1, ) until the last dose (up to 2 years) |
| Trough plasma concentration (Ctrough) | From first dose (Cycle 1 Day 1, ) until the last dose (up to 2 years) |
Countries
Australia, Singapore, United States
Outcome results
None listed