Clinical trial
A First-in-Human (FIH), Open-Label, Phase 1/2 Dose Escalation and Expansion Study of ADG126, ADG126 in Combination With Anti PD1 Antibody, and ADG126 in Combination With ADG106 in Patients With Advanced/Metastatic Solid Tumors
Name
ADG126-1001
Description
ADG126, ADG126 in Combination with anti-PD1 antibody, and ADG126 in Combination with ADG106 in Patients with Advanced/Metastatic Solid Tumors .
Trial arms
Trial start
2021-03-15
Estimated PCD
2024-03-31
Trial end
2024-12-31
Status
Recruiting
Phase
Early phase I
Treatment
ADG126 Mono
ADG126 will be administered as an IV infusion over 30-60 minutes ± 15 minutes.
Arms:
ADG126 mono dose escalation, ADG126 mono dose expansion
ADG126-anti PD1
ADG126-toripalimab combination regimen will receive of toripalimab 15 to 30 minutes after the end of the ADG126 infusion
Arms:
ADG126-anti PD1 drug dose escalation, ADG126-anti PD1 drug dose expansion
ADG126-ADG106
ADG126-ADG106 combination regimen will be receive of ADG106 15 to 30 minutes after the end of the ADG126 infusion
Arms:
ADG126-ADG106 dose escalation, ADG126-ADG106 dose expansion
Size
91
Primary endpoint
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
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 91, 'type': 'ESTIMATED'}}
Updated at
2023-02-24
1 organization
2 products
1 indication
Organization
AdageneProduct
ADG126Indication
Advanced/Metastatic Solid TumorsProduct
ADG126-ADG106