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GQ1001 Combined With Pyrotinib for Treatment With HER2 Positive Metastatic Breast Cancer

NCT05575804 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2024-02-26

No results posted yet for this study

Summary

The aim of this trial is to study the safety, pharmacokinetics and preliminary efficacy of the HER2-targeted antibody-drug conjugate GQ1001 in combination with pyrotinib in patients with HER2-positive metastatic breast cancer patients who had failed previous anti-HER2 treatment.

Conditions

  • Advanced/ Metastatic Her-2 Positive Breast Cancer

Interventions

DRUG

GQ1001+pyrotinib

GQ1001 infusions on day 1 of each 21-day cycle combinate with pyrotinib 320mg orally once daily until disease progression or unacceptable toxicity. I.

DRUG

pyrotinib+capecitabine

pyrotinib 400mg orally once daily in combination with capecitabine 1000mg/m2 twice daily, day1-14, every three weeks until disease progression or unacceptable toxicity.

Sponsors & Collaborators

  • GeneQuantum Healthcare (Suzhou) Co., Ltd.

    collaborator INDUSTRY

  • Fudan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2025-01-01
Completion
2025-01-01

Countries

  • China

Study Locations

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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 NCT05575804 on ClinicalTrials.gov