Combining ADG126 with Pembrolizumab for Advanced Solid Tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1b/2 clinical trial evaluates the safety, tolerability, pharmacokinetics, and immunogenicity of the combination of ADG126, an anti-CTLA-4 monoclonal antibody, with Pembrolizumab, a PD-1 receptor-blocking antibody, in patients with advanced or metastatic solid tumors. The study is designed as an open-label, multicenter, dose escalation and expansion trial, focusing on patients who have progressed after standard therapies or have no further treatment options available. Participants will undergo assessments to determine the effectiveness of this combination therapy in managing their condition.

Why it matters

Who can join: the full rules

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.

Where it's running

• Honor Health Research Institute
  Scottsdale, Arizona, United States Recruiting
• City of Hope National Medical Center
  Duarte, California, United States Recruiting
• City of Hope Orange County
  Irvine, California, United States Recruiting
• The Cleveland Clinic
  Cleveland, Ohio, United States Recruiting
• MD Anderson Cancer Center
  Houston, Texas, United States Recruiting
• Fred Hutchinson Cancer Center
  Seattle, Washington, United States Recruiting

Study contacts

• Study coordinator: Xiaohong She, MS
• Email: kristine_she@adagene.com
• Phone: 408-838-9296

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.