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Pembrolizumab and ADG106 in Advanced Solid Cancers and Triple Negative Breast Cancer

NCT05491083 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2025-07-25

No results posted yet for this study

Summary

This is a phase Ib followed by phase II clinical trial evaluating the safety and efficacy of combination of ADG106 with pembrolizumab in patients with metastatic cancers. The Phase Ib dose finding part will include all solid tumor subtypes with treatment refractory disease, while phase II will focus on only patients with TNBC.

Conditions

Interventions

DRUG

Pembrolizumab & ADG106 (Phase Ib)

Drug: ADG106 Administered as an intravenous infusion over 60-90 minutes in the initial cycle and over 30 minutes in subsequent cycle if well tolerated. Pembrolizumab Administered as an intravenous infusion over 30 minutes

DRUG

Pembrolizumab & ADG106 (Phase II)

Drug: ADG106 Administered as an intravenous infusion over 60-90 minutes in the initial cycle and over 30 minutes in subsequent cycle if well tolerated. Pembrolizumab Administered as an intravenous infusion over 30 minutes

Sponsors & Collaborators

  • Adagene Inc

    collaborator INDUSTRY

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • National University Hospital, Singapore

    lead OTHER

Principal Investigators

  • Soo Chin Lee · National University Hospital, Singapore

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
21 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-12
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Singapore

Study Locations

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Entities

Diseases
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 NCT05491083 on ClinicalTrials.gov