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

NCT05405595 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2026-01-07

No results posted yet for this 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).

Conditions

  • Advanced/Metastatic Solid Tumors

Interventions

DRUG

ADG126

ADG126 is an anti-CTLA-4 fully human monoclonal antibody that specifically binds to human CTLA-4.

DRUG

Pembrolizumab (KEYTRUDA®)

Pembrolizumab (KEYTRUDA®) is a PD-1 receptor-blocking antibody (a humanized IgG4 monoclonal antibody).

DRUG

Standard of Care (Trifluridine/Tipiracil-Bevacizumab)

The standard of care therapies will include Trifluridine/Tipiracil-Bevacizumab, approved for treating metastatic colorectal cancer (CRC)and various solid tumors.

DRUG

Standard of care (Fruquintinib)

The standard of care therapy, Fruquintinib, is approved for treating metastatic colorectal cancer (CRC) and various solid tumors.

Sponsors & Collaborators

Principal Investigators

  • Jiping Zha, MD, PhD · Adagene Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-15
Primary Completion
2026-10-31
Completion
2027-04-30
FDA Drug
Yes

Countries

  • United States
  • China
  • South Korea

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05405595 on ClinicalTrials.gov