Clinical trial · Interventional
ADG126, ADG126 in Combination With Anti PD1 Antibody, and ADG126 in Combination With ADG106 in Advanced/Metastatic Solid Tumors
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
NCT04645069CI-TRIAL-00079800completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
ADG126, ADG126 in Combination with anti-PD1 antibody, and ADG126 in Combination with ADG106 in Patients with Advanced/Metastatic Solid Tumors .
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced/Metastatic Solid Tumors | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ADG126-ADG106 | Biological | — | UNRESOLVED |
| ADG126-anti PD1 | Biological | — | UNRESOLVED |
| ADG126 Mono | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- ADG126 mono dose escalation
- description
- ADG126 monotherapy dose escalation will be traditional 3+3 cohort design.
- interventionNames
- Biological: ADG126 Mono
- type
- EXPERIMENTAL
- label
- ADG126 mono dose expansion
- description
- Monotherapy dose expansion is designed to evaluate the preliminary antitumor activity of ADG126 at RP2D or the doses approved by the SRC.
- interventionNames
- Biological: ADG126 Mono
- type
- EXPERIMENTAL
- label
- ADG126-anti PD1 drug dose escalation
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.