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

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. According to ClinicalTrials.gov, the official US trial registry.

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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).

Primary Outcome

To determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) for ADG126+ pembrolizumab in dose escalation levels

Conditions Studied

Advanced/Metastatic Solid Tumors

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
Adagene

6 total trials

What NCT05405595 shows while recruiting

NCT05405595 is an interventional study that assigns participants to a tested intervention. The registered 186 participants enrollment target is mid-sized for trials with a published cap, below the 283-participant average among 4 other Advanced/Metastatic Solid Tumors trials with a reported enrollment target (34% lower).

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 names 20 study sites across 14 states, led by 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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More recruiting context for NCT05405595

Source: ClinicalTrials.gov NCT05405595, the US trial registry maintained by the National Library of Medicine. NCT05405595 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.