A Trial Comparing GQ1005 and T-DM1 in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer

Official title

A Phase III, Multicenter, Open-label, Randomized Controlled Study Comparing GQ1005 and Trastuzumab Emtansine (T-DM1) in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer Previously Treated With Trastuzumab and a Taxane

Overview

This study is designed to compare efficacy and safety of GQ1005 versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer patients previously treated with trastuzumab and taxane.

Detailed description

This is a phase III, multicenter, open-label, randomized controlled study comparing GQ1005 with Trastuzumab Emtansine (T-DM1) in patients with HER2-positive unresectable or metastatic breast cancer previously treated with trastuzumab and taxane. Approximately 228 patients with unresectable or metastatic HER2-positive breast cancer will be randomized 1:1 to receive GQ1005 or T-DM1, respectively.

Interventions

• Drug GQ1005
  Administered I.V.
• Drug T-DM1
  Administered I.V.

Primary outcome measures

• Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) assessment per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) [Time frame: Up to approximately 24 months]

Secondary outcome measures (11)

• Overall Survival (OS) [Time frame: Up to approximately 24 months]
• Progression Free Survival (PFS) by Investigator assessment per RECIST 1.1 [Time frame: Up to approximately 24 months]
• Objective response rate (ORR) by BICR and investigator assessment per RECIST 1.1 [Time frame: Up to approximately 24 months]
• Duration of response (DoR) by BICR and investigator assessment per RECIST 1.1 [Time frame: Up to approximately 24 months]
• Disease Control Rate (DCR) by BICR and investigator assessment per RECIST 1.1 [Time frame: Up to approximately 24 months]
• Adverse events：Number and percentage of patients who report serious adverse events (SAEs), treatment-emergent adverse events (TEAEs), TEAEs leading to study drug discontinuation, adverse events of special interest (AESIs) (graded according to the Nationa [Time frame: Up to approximately 24 months]
• PK parameters：Plasma concentrations of GQ1005 ADC, total anti-HER2 antibody and free toxin DXd at each time point [Time frame: Up to approximately 24 months]
• Anti-drug antibodies (ADA)：Number and percentage of patients who develop anti-drug antibody (ADA). [Time frame: Up to approximately 24 months]
• Quality of Life Assessment：Change in Health-Related Quality of Life Assessed by EQ-5D-5L [Time frame: Up to approximately 24 months]
• Quality of Life Assessment：Change in Health-Related Quality of Life Assessed by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) - C30 [Time frame: Up to approximately 24 months]
• Quality of Life Assessment：Change in Health-Related Quality of Life Assessed by EORTC QLQ-BR45 [Time frame: Up to approximately 24 months]

Eligibility criteria

Inclusion criteria

• Male or female adults ≥ 18 years at the time of voluntary signing of informed consent.
• Pathologically confirmed unresectable or metastatic HER2 positive breast cancer previously treated with trastuzumab and taxane
• Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1.
• Presence of at least one measurable lesion according to RECIST v1.1
• Expected survival time ≥ 12 weeks.
• Patients must give informed consent to this study and voluntarily sign written informed consent form prior to the study NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Exclusion criteria

• Prior anti-HER2 ADC therapy.
• Previous history of interstitial lung disease/noninfectious pneumonitis/radiation pneumonitis requiring steroid therapy.
• Known serious hypersensitivity to the active ingredients of the study drug, inactive ingredients in the formulation, or other antibody drugs.
• Multiple primary malignancies within 3 years, except for adequately resected non-melanoma skin cancer, curatively treated in situ tumor, or contralateral breast cancer
• Uncontrolled infection requiring intravenous antibiotics, antiviral or antifungal agents, autoimmune disease requiring treatment, uncontrolled diabetes, hypertension, or other systemic disease that makes compliance with study procedures difficult
• Unrecovered toxicity from prior anticancer therapy, defined as toxicity (except for alopecia) not recovered to ≤Grade 1 (NCI-CTCAE v5.0) or baseline.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 70 centers

• The First Affiliated Hospital of Bengbu Medical University — Bengbu
• The Affiliated Fuyang Hospital of Anhui Medical University — Fuyang
• The First Affiliated Hospital of Anhui Medical University — Hefei
• Anhui Cancer Hospital — Hefei
• The Fifth Medical Center of the Chinese People's Liberation Army General Hospital — Beijing
• Chongqing University Cancer Hospital — Chongqing
• Fujian Cancer Hospital — Fuzhou
• The Second Affiliated Hospital of Fujian Medical University — Quanzhou
• … and 62 more centers

Identifiers

NCT: NCT07673029 · GQ1005-301

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗