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GB268 Monotherapy or Combination Therapy for Locally Advanced/Metastatic Breast Cancer (Phase Ib/Ⅱ)

NCT07738341 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2026-07-31

No results posted yet for this study

Summary

This is a Phase Ib/II, open-label, multi-cohort, multi-center study to evaluate the safety, tolerability, and preliminary anti-tumor activity of GB268, a biological product, as monotherapy or in combination with other therapies in patients with locally advanced unresectable or metastatic breast cancer.

Conditions

  • Breast Cancer (Locally Advanced or Metastatic)

Interventions

DRUG

GB268

GB268 is a tri-specific antibody targeting PD-1, CTLA-4, and VEGF. It is designed to block immune checkpoints (PD-1/CTLA-4) to enhance T-cell-mediated anti-tumor immune responses and simultaneously inhibit VEGF-mediated tumor angiogenesis

DRUG

Nab-Paclitaxel

Nab-Paclitaxel is a microtubule-stabilizing agent formulated as albumin-bound nanoparticles for IV administration.

DRUG

Datopotamab Deruxtecan (Dato-DXd)

Datopotamab Deruxtecan is an ADC targeting Trop-2, consisting of a monoclonal antibody linked to a topoisomerase I inhibitor payload.

DRUG

Sacituzumab Tirumotecan

A Trop-2-directed Antibody-Drug Conjugate \[ADC\] consisting of a humanized anti-Trop-2 monoclonal antibody covalently linked to a topoisomerase I inhibitor payload.

Sponsors & Collaborators

  • Eddingpharm (Zhuhai) Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2029-08-01
Completion
2030-08-01

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Drugs

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 NCT07738341 on ClinicalTrials.gov