Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 1

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

NCT05405595 · View on ClinicalTrials.gov ↗

Study 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).

Interventions

  • DRUG Pembrolizumab (KEYTRUDA®)
  • DRUG ADG126
  • DRUG Standard of Care (Trifluridine/Tipiracil-Bevacizumab)
  • DRUG Standard of care (Fruquintinib)

Study Locations (20)

Other

  • Keimyung University Dongsan Hospital — Daegu
  • Seoul National University Hospital — Seoul
  • KangBuk Samsung Hospital — Seoul
  • Asan Medical Center — Seoul

California

  • City of Hope National Medical Center — Duarte
  • City of Hope Orange County — Irvine

Hong Kong

  • Hong Kong Humanity & Health Clinical Trial Center — Hong Kong
  • Prince of Wales Hospital — Hong Kong

Gyeonggido

  • CHA Bundang Medical Center, CHA university — Seongnam
  • The Catholic University of Korea Street. Vincent Hospital — Suwon

Arizona

  • Honor Health Research Institute — Scottsdale

Florida

  • Florida cancer specialist/Sarah Cannon Research Institute — Sarasota

Ohio

  • The Cleveland Clinic — Cleveland

Texas

  • MD Anderson Cancer Center — Houston

Trial Details

FieldValue
Enrollment Target 186 participants
Start Date 2022-06-15
Est. Completion 2027-04-30
Phase Phase 1

Sponsor

Adagene

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05405595

The ClinicalTrials.gov registry entry for NCT05405595 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 186 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Adagene, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Advanced/Metastatic Solid Tumors appearing as the primary indexed condition, and to 4 interventions — of which Pembrolizumab (KEYTRUDA®) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05405595 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Other, California, Hong Kong. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05405595 about?

NCT05405595 is a clinical study titled "ADG126 in Combination With Pembrolizumab in Patients With Advanced/Metastatic Solid Tumors". 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 hu...

What is the current status of trial NCT05405595?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 186 participants. The study started on 2022-06-15. Estimated completion is 2027-04-30.

What conditions does trial NCT05405595 study?

This clinical trial studies the following conditions: Advanced/Metastatic Solid Tumors. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05405595?

The interventions under investigation include: Pembrolizumab (KEYTRUDA®) (DRUG), ADG126 (DRUG), Standard of Care (Trifluridine/Tipiracil-Bevacizumab) (DRUG), Standard of care (Fruquintinib) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05405595?

This trial is sponsored by Adagene, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05405595 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial