癌研連線CancerLink
Recruiting NCT05405595

ADG126 in Combination With Pembrolizumab in Patients With Advanced/Metastatic Solid Tumors

未指定Phase 1Stage IIIStage IVPD-L1

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).

Conditions: Advanced/Metastatic Solid Tumors

Eligibility Criteria

Inclusion Criteria

  • ≥18 years of age at the time of informed consent.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • Wash out period from previous antitumor therapies
  • At least 1 measurable lesion at baseline according to the definition of RECIST v1.1.
  • Adequate organ function.
  • An archival tumor biopsy is required and should be taken within 2 years of enrollment. If not available, a fresh tumor biopsy is acceptable.
  • 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.
  • Dose Expansion Phase Only: Tumor tissues (archived tissue) before treatment are required for all patients.

Exclusion Criteria

  • Pregnant or breastfeeding females.
  • Childbearing potential who does not agree to the use of contraception during the treatment period.
  • Treatment with any investigational drug within washout period.
  • Prior treatment with a PD-1, PD-L1 targeting agent or a next-generation anti-CTLA-4 therapy with enhanced ADCC function.
  • History of significant irAEs or irAE.
  • Central nervous system (CNS) disease involvement.
  • History or risk of autoimmune disease.
  • Patients requiring systemic treatment with corticosteroids or other immunosuppressive medications (\>10 mg/day prednisone or equivalent).
  • Any uncontrolled active infections requiring systemic antimicrobial treatment (viral, bacterial, or other), or uncontrolled or poorly controlled, asthma, chronic obstructive pulmonary disease (COPD).
  • Major surgery within 4 weeks prior to the first dose of the study drug.
  • Has had an allogeneic tissue/solid organ transplant.
  • 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.
  • A positive COVID-19 test within 14 days of Cycle 1 Day 1.
  • History of Hypersensitivity or known to be allergic to protein drugs or recombinant protein.
  • Active hemoptysis or central airway invasion by metastatic tumor.

Eligibility criteria are kept as the original English records from ClinicalTrials.gov; actual eligibility is determined by the research team's formal assessment and the informed consent form. Source: ClinicalTrials.gov, updated automatically every two weeks. Last synced: 2026年10月8日.