ACTRN12620000592943
Recruiting
Phase 1
A Phase I, First-In-Human, Multicenter, Open-Label, Study of GQ1001, a HER2 Targeted Antibody-Drug Conjugate, Administered Intravenously in Adult Patients with HER2-Positive Advanced Solid Tumors
Conjugate Light (Australia) Pty Ltd0 sites13 target enrollmentMay 21, 2020
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- HER2-Positive Advanced Solid Tumors
- Sponsor
- Conjugate Light (Australia) Pty Ltd
- Enrollment
- 13
- Status
- Recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients who are voluntary to participate in this clinical study, able to understand the study procedure, and have signed the informed consent form.
- •2\. Male or female subjects 18 years of age and older.
- •3\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening;
- •4\. Left ventricular ejection fraction (LVEF) greater than or equal to 50% by echocardiography
- •5\. Patients must have pathologically documented advanced/unresectable or metastatic solid tumor with HER2 overexpression/expression (refer to the following definition) that is refractory to standard therapy or for which there is no standard available therapy:
- •\- advanced/unresectable or metastatic breast cancer: IHC 3\+ or IHC 2\+/ISH\* \+; \- Advanced/unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma: IHC 3\+ or IHC
- •2\+/ISH\* \+;
- •\- Other advanced/unresectable or metastatic solid malignant tumor: determined by IHC, FISH, Next Generation Sequencing, or other analysis techniques as appropriate.
- •\- ISH: FISH or DISH
- •6\. Has adequate organ function within 7 days before the first treatment defined as:
Exclusion Criteria
- •1\. Clinically active brain metastases, defined as untreated and symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms. Subjects with treated brain metastases that are no longer symptomatic and who require no treatment with steroids may be included in the study if they have recovered from the acute toxic effect of radiotherapy;
- •2\. Any hematologic malignancies, including leukemia (any form), lymphoma, and multiple myeloma;
- •3\. Cardiovascular dysfunction as defined by;
- •\- Has a medical history of symptomatic CHF (NYHA classes II\-IV) or serious cardiac arrhythmia requiring treatment;
- •\- Has a medical history of myocardial infarction or unstable angina within 6 months before registration;
- •\- Has a QTc prolongation to greater than 450 millisecond (ms) in males and greater than 470 ms in females based on 12\-lead ECG in triplicate;
- •4\. Medical history of clinically significant lung disease (e.g. interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis), or patients who are suspected to have these diseases by imaging at screening or requirement for supplemental oxygen;
- •5\. Known hypersensitivity to either the drug substances or inactive ingredients in the drug product;
- •6\. Grade greater than or equal to 2 peripheral neuropathy;(Note: for patients who relapsed or refractory to Kadcyla®, patients who have grade \= 2 peripheral neuropathy may be eligible per the discretion of the Investigator after discussion with the Sponsor);
- •7\. Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI\-CTCAE version 5\.0, grade less than or equal to 1 or baseline. Subjects with chronic grade 2 toxicities may be eligible per the discretion of the Investigator;
Outcomes
Primary Outcomes
Not specified
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