ADG126, ADG126 in Combination With Anti PD1 Antibody, and ADG126 in Combination With ADG106 in Advanced/Metastatic Solid Tumors
Completed · Phase 1/Phase 2
Conditions studied: Advanced/Metastatic Solid Tumors
In brief
ADG126, ADG126 in Combination with anti-PD1 antibody, and ADG126 in Combination with ADG106 in Patients with Advanced/Metastatic Solid Tumors .
Key facts
- Study ID
- NCT04645069
- Run by
- Adagene Inc
- People needed
- 58
- Starts
- 2021-03-15
- Expected to finish
- 2024-05-17
- Last updated by the study team
- 2024-08-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University of California Los Angeles — Los Angeles, California, United States
- Next oncology — San Antonio, Texas, United States
- Southside Cancer Care Centre — Miranda, New South Wales, Australia
- Macquarie University Hospital — Sydney, New South Wales, Australia
- Sunshine Coast University Private Hospital — Birtinya, Queensland, Australia
- Cabrini Health Limited — Malvern, Victoria, Australia
- One Clinical Research Pty Ltd — Nedlands, Western Australia, Australia
- National University Hospital — Singapore, Singapore
- National Cancer Centre Singapore — Singapore, Singapore
Full record on ClinicalTrials.gov
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