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NCT05405595 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Advanced/Metastatic Solid Tumors, sponsored by Adagene.

Recruiting
Registry status
Phase 1
Development phase
186
Enrollment target
20
Study locations

NCT05405595 is a Phase 1 study of Advanced/Metastatic Solid Tumors that is actively recruiting participants, run by Adagene. The registered enrollment target is 186 participants, below the 283-participant average among 4 other Advanced/Metastatic Solid Tumors trials with a reported enrollment target (34% lower). The trial reports 20 study locations across 14 states.

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The verdict

NCT05405595, a Phase 1 study of Advanced/Metastatic Solid Tumors, is actively recruiting participants, sponsored by Adagene.

RECRUITING
Registry status
Phase 1
Development phase
186 participants
Enrollment target
20
Study locations

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

6 total trials

What the Registry Record Tells You About NCT05405595

The ClinicalTrials.gov registry entry for NCT05405595 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 186 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 283-participant average among 4 other Advanced/Metastatic Solid Tumors trials with a reported enrollment target (34% lower). The listed sponsor is Adagene, which has 6 total studies on file at ClinicalTrials.gov.

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.

NCT05405595 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Other, California, Hong Kong.

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.

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).

Who is sponsoring clinical trial NCT05405595?

This trial is sponsored by Adagene, which has 6 total clinical trials registered on ClinicalTrials.gov.

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.