NCT05405595 ADG126 in Combination With Pembrolizumab in Patients With Advanced/Metastatic Solid Tumors
| NCT ID | NCT05405595 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Adagene Inc |
| Condition | Advanced/Metastatic Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 186 participants |
| Start Date | 2022-06-15 |
| Primary Completion | 2026-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 186 participants in total. It began in 2022-06-15 with a primary completion date of 2026-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a Phase 1b/2, open-label, dose escalation, dose expansion and dose optimization study to evaluate the safety, tolerability, PK, and immunogenicity of ADG126-pembrolizumab combination regimens in patients with advanced/metastatic solid tumors. The study drug ADG126 is an anti-CTLA-4 fully human monoclonal antibody that specifically binds to human CTLA-4. Pembrolizumab is a PD-1 receptor-blocking antibody (a humanized IgG4 monoclonal antibody).
Eligibility Criteria
Inclusion Criteria: 1. ≥18 years of age at the time of informed consent. 2. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 3. Wash out period from previous antitumor therapies 4. At least 1 measurable lesion at baseline according to the definition of RECIST v1.1. 5. Adequate organ function. 6. An archival tumor biopsy is required and should be taken within 2 years of enrollment. If not available, a fresh tumor biopsy is acceptable. 7. For Dose Escalation Phase Only: Patients with histologically or cytologically confirmed, locally advanced or metastatic solid tumors, who have progressed after all standard therapies, or for whom no further standard therapy exists. 8. Dose Expansion Phase Only: Tumor tissues (archived tissue) before treatment are required for all patients. Exclusion Criteria: 1. Pregnant or breastfeeding females. 2. Childbearing potential who does not agree to the use of contraception during the treatment period. 3. Treatment with any investigational drug within washout period. 4. Prior treatment with a PD-1, PD-L1 targeting agent or a next-generation anti-CTLA-4 therapy with enhanced ADCC function. 5. History of significant irAEs or irAE. 6. Central nervous system (CNS) disease involvement. 7. History or risk of autoimmune disease. 8. Patients requiring systemic treatment with corticosteroids or other immunosuppressive medications (\>10 mg/day prednisone or equivalent). 9. Any uncontrolled active infections requiring systemic antimicrobial treatment (viral, bacterial, or other), or uncontrolled or poorly controlled, asthma, chronic obstructive pulmonary disease (COPD). 10. Major surgery within 4 weeks prior to the first dose of the study drug. 11. Has had an allogeneic tissue/solid organ transplant. 12. Has received a COVID-19 vaccine within 7 days prior to the first dose of study treatment. Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study treatment. Note: Administration of killed vaccines are allowed. 13. A positive COVID-19 test within 14 days of Cycle 1 Day 1. 14. History of Hypersensitivity or known to be allergic to protein drugs or recombinant protein. 15. Active hemoptysis or central airway invasion by metastatic tumor.
Contact & Investigator
Jiping Zha, MD, PhD
STUDY DIRECTOR
Adagene Inc
Frequently Asked Questions
Who can join the NCT05405595 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced/Metastatic Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05405595 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05405595 currently recruiting?
Yes, NCT05405595 is actively recruiting participants. Contact the research team at kristine_she@adagene.com for enrollment information.
Where is the NCT05405595 trial being conducted?
This trial is being conducted at Scottsdale, United States, Duarte, United States, Irvine, United States, Sarasota, United States and 11 additional locations.
Who is sponsoring the NCT05405595 clinical trial?
NCT05405595 is sponsored by Adagene Inc. The principal investigator is Jiping Zha, MD, PhD at Adagene Inc. The trial plans to enroll 186 participants.