ADG126, ADG126 in Combination With Anti PD1 Antibody, and ADG126 in Combination With ADG106 in Advanced/Metastatic Solid Tumors
About the study
ADG126, ADG126 in Combination with anti-PD1 antibody, and ADG126 in Combination with ADG106 in Patients with Advanced/Metastatic Solid Tumors .
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion criteria
- Adults ≥18 years of age.
- ECOG performance status 0 or 1.
- Estimated life expectancy of more than 12 weeks .
- 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.
- At least 1 measurable lesion at baseline according to the definition of RECIST v1.1.
- Adequate organ function.
- Meets the additional tumor type requirements as specified in Protocol.
EXCLUSION CRITERIA
Exclusion Criteria:
- Treatment with any investigational drug within washout period.
- Major trauma or major surgery within 4 weeks prior to first dose of study drug(s)
- History of significant immune-mediated AE.
- Central nervous system (CNS) disease involvement.
- Prior organ allograft transplantations or allogeneic peripheral blood stem cell (PBSC)/bone marrow (BM) transplantation
- Clinically significant cardiac disease.
- Evidence of active uncontrolled viral, bacterial, or systemic fungal infection.
Patients who received:
- A COVID-19 vaccine within 7 days of Cycle 1 Day 1.
- Live vaccines or live-attenuated vaccines within 28 days prior to Cycle 1 Day 1.
- Known active infection of HBV/BCV/HIV.
- Patients requiring systemic treatment with corticosteroids or other immunosuppressive medications (>10 mg/day prednisone or equivalent).
- Second primary malignancy not in remission for greater than 3 years.
- History(within the last 5 years) or risk of autoimmune disease.
- Pregnant or breastfeeding females.
- Childbearing potential who does not agree to the use of contraception during the treatment period.
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Advanced/Metastatic Solid Tumors
Age (in years)
18+
Phase
Phase 1/Phase 2
Participants needed
91
Est. Completion Date
Dec 31, 2024
Treatment type
Interventional
Sponsor
Adagene Inc
ClinicalTrials.gov identifier
NCT04645069
Study number
ADG126-1001
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