ADG126, ADG126 in Combination With Anti PD1 Antibody, and ADG126 in Combination With ADG106 in Advanced/Metastatic Solid Tumors
NCT ID: NCT04645069
Last Updated: 2024-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
58 participants
INTERVENTIONAL
2021-03-15
2024-05-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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ADG126 mono dose escalation
ADG126 monotherapy dose escalation will be traditional 3+3 cohort design.
ADG126 Mono
ADG126 will be administered as an IV infusion over 30-60 minutes ± 15 minutes.
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.
ADG126 Mono
ADG126 will be administered as an IV infusion over 30-60 minutes ± 15 minutes.
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.
ADG126-anti PD1
ADG126-toripalimab combination regimen will receive of toripalimab 15 to 30 minutes after the end of the ADG126 infusion
ADG126-anti PD1 drug dose expansion
Combination therapy expansion will commence at RP2D or the dose approved by the SRC.
ADG126-anti PD1
ADG126-toripalimab combination regimen will receive of toripalimab 15 to 30 minutes after the end of the ADG126 infusion
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.
ADG126-ADG106
ADG126-ADG106 combination regimen will be receive of ADG106 15 to 30 minutes after the end of the ADG126 infusion
ADG126-ADG106 dose expansion
Combination therapy expansion will commence at RP2D or the dose approved by the SRC.
ADG126-ADG106
ADG126-ADG106 combination regimen will be receive of ADG106 15 to 30 minutes after the end of the ADG126 infusion
Interventions
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ADG126 Mono
ADG126 will be administered as an IV infusion over 30-60 minutes ± 15 minutes.
ADG126-anti PD1
ADG126-toripalimab combination regimen will receive of toripalimab 15 to 30 minutes after the end of the ADG126 infusion
ADG126-ADG106
ADG126-ADG106 combination regimen will be receive of ADG106 15 to 30 minutes after the end of the ADG126 infusion
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Adagene Inc
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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ADG126-1001
Identifier Type: -
Identifier Source: org_study_id
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