ADG126, ADG126 in Combination With Anti PD1 Antibody, and ADG126 in Combination With ADG106 in Advanced/Metastatic Solid Tumors
- Conditions
- Advanced/Metastatic Solid Tumors
- Registration Number
- NCT04645069
- Lead Sponsor
- Adagene Inc
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
Not provided
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Treatment with any investigational drug within washout period.
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Major trauma or major surgery within 4 weeks prior to first dose of study drug(s)
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History of significant immune-mediated AE.
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Central nervous system (CNS) disease involvement.
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Prior organ allograft transplantations or allogeneic peripheral blood stem cell (PBSC)/bone marrow (BM) transplantation
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Clinically significant cardiac disease.
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Evidence of active uncontrolled viral, bacterial, or systemic fungal infection.
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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.
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Known active infection of HBV/BCV/HIV.
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Patients requiring systemic treatment with corticosteroids or other immunosuppressive medications (>10 mg/day prednisone or equivalent).
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Second primary malignancy not in remission for greater than 3 years.
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History(within the last 5 years) or risk of autoimmune disease.
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Pregnant or breastfeeding females.
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Childbearing potential who does not agree to the use of contraception during the treatment period.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Primary Outcome Measures
Name Time Method 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 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
- Secondary Outcome Measures
Name Time Method 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) 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) Antidrug antibodies (ADAs) 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)
Trial Locations
- Locations (9)
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
University of California Los Angeles🇺🇸Los Angeles, California, United States