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

ACTRN 12620000592943

Brief Summary

This purpose of this study is to determine a safe dosethe amount of medication taken for GQ1001 in patients with HER-2 Positive Advancedat a late stage, far along Solid Tumors.

Intervention/Treatment

• Drug: GQ1001

Inclusion Criteria

1. Patients who are voluntary to participate in this clinical study, able to understand the study procedure, and have signed the informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment. form.
2. Male or female subjects 18 years of age and older.
3. Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance status of 0 or 1 at screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer 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 cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs: IHC 3+ or IHC 2+/ISH* +; – Advanced/unresectable or metastatic gastric or gastroesophageal junction adenocarcinomacancer arising from mucus-producing glands in organs: IHC 3+ or IHC 2+/ISH* +;
   • Other advanced/unresectable or metastatic solid malignantcancerous, may grow and spread to other areas of the body 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:
   • Platelet count greater than or equal to 100 000/mm^3.
   • Hemoglobin (Hb) greater than or equal to 9 g/dL.
   • Absolute neutrophil count (ANC) greater than or equal to 1500/mm^3.
   • Serum Creatinine less than or equal to 1.5 × ULN, or creatinine clearance greater than or equal to 60 mL/min (using Cockcroft-Gault formula).
   • AST/ALT less than or equal to 2.5 × ULN (if liver metastases are present, less than or equal to 5 × ULN).
   • Total bilirubin less than or equal to 1.5 × ULN.
   • Prothrombin time and activated partial thromboplastin time less than or equal 1.5 × ULN.
7. Has adequate treatment washout period before the first treatment, defined as:
   • Major surgerytreatment involving removal of cancerous tissue and/or tumours and a margin of healthy tissue around it to reduce recurrence greater than or equal to 4 weeks.
   • Radiation therapya treatment that uses controlled doses of radiation to damage or kill cancer cells greater than or equal to 4 weeks (if palliative stereotactic radiation therapy without abdominal, greater than or equal to 2 weeks).
   • Autologous transplantation greater than or equal to 3 months.
   • Hormonal therapy greater than or equal to 2 weeks.
   • Chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells or other target therapy (including antibodya protein made by the immune system to fight against harmful substances (antigens), such as bacteria or viruses drug therapy) greater than or equal to 3 weeks (greater than or equal to 2 weeks for 5-fluorouracil-based agents, HER2-directed therapies greater than or equal to 4 weeks; folinate agents and/or weekly Paclitaxel; greater than or equal to 6 weeks for nitrosoureas or mitomycin C);
   • Immunotherapya treatment that uses a person's immune system to fight cancer greater than or equal to 4 weeks.
   • CYP3A4 strong inhibitor greater than or equal to 3 elimination half-lives of the inhibitor.
   • Any investigational agents or treatments greater than or equal to 4 weeks.
8. Patients without a history of AIDS-defining opportunistic infections or with a history of AIDS-defining opportunistic infections and have not had an opportunistic infectiona condition where harmful pathogens, such as bacteria, viruses or parasites, have entered the body within the past 12 months may be enrolled per the discretion of the Investigator.