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Completed Phase 1 Interventional

ADG116 in Combination With Pembrolizumab in Patients With Advanced/Metastatic Solid Tumors

ClinicalTrials.gov ID: NCT05277402

Public ClinicalTrials.gov record NCT05277402. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 6:41 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 1b, Open-Label, Dose Escalation Study of ADG116 in Combination With Pembrolizumab (Anti-PD-1 Antibody) in Patients With Advanced/Metastatic Solid Tumors

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a Phase 1b, open-label, dose escalation study to evaluate the safety, tolerability, PK, and immunogenicity of an ADG116-pembrolizumab combination regimen in patients with advanced/metastatic solid tumors. Study drug ADG116, 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) which is indicated for the treatment of patients across a number of indications. The treatment strategy of using anti-PD 1 therapy combined with anti-CTLA-4 therapy is to explore the potential of combination checkpoint inhibition regimens for the enhanced antitumor efficacy results.

Study identification

NCT ID
NCT05277402
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Adagene Inc
Industry
Enrollment
6 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 9, 2022 (Actual)
Primary completion
Aug 1, 2022 (Actual)
Completion
Dec 1, 2022 (Actual)
Last update posted
Feb 26, 2024

2022

United States locations

U.S. sites
2
U.S. states
2
U.S. cities
2
Facility City State ZIP Site status
Carolina BioOncology Institute Huntersville North Carolina 28078 —
Next Oncology San Antonio Texas 78229 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05277402, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 26, 2024 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05277402 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →