Safety of GQ1001 in Adult Patients With HER2-Positive Advanced Solid Tumors

• Drug: GQ1001

Inclusion Criteria

1. Signed 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 and able to comply with the protocol;
2. Male and female subjects ≥18 years of age;
3. ECOG PS of 0 or 1, the estimated life expectancy ≥ 3 months;
4. LVEF ≥ 50% as determined by echocardiography (ECHO);
5. Patients must have pathologically documented advanced/unresectable or metastatic solid tumor with HER2-positive (as defined below) that is relapsed or refractory to standard therapy or for which there is no standard therapy and progressed. Patients must have a least one measurable disease lesion. Tumor specimens to identify HER2 status should be obtained within the past 6 months.Definition of HER2-positive
   • Advanced/unresectable or metastatic breast cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs: immunohistochemistry (IHC) 3+, or IHC 2+ and in situ hybridization positive (ISH+)*;
   • Advanced/unresectable or metastatic gastric or gastroesophageal junction adenocarcinomacancer arising from mucus-producing glands in organs: IHC 3+, or IHC 2+ and ISH+*;
   • Other HER2-positive advanced/unresectable or metastatic solid malignantcancerous, may grow and spread to other areas of the body tumor: determined by IHC, ISH, Next Generation Sequencing, or other analysis techniques as appropriate;
     • ISH: fluorescence in situ hybridization (FISH) or dual in situ hybridization (DISH); ISH positivity is defined as a ratio of ≥ 2.0 for the number of HER2 gene copies to the number of signals for CEP17. ISH assay is not required when IHC result is 3+. ISH assay should be performed to confirm HER2 positivity when IHC result is 2+.
6. Adequate organ function confirmed at screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening and within 7 days before the first treatment, as evidenced by:Platelet count: ≥ 100,000/mm3 ; Hemoglobin : ≥ 9 g/dL; Absolute neutrophil count (ANC): ≥ 1500/mm3 ; Serum creatinine: ≤ 1.5 × ULN (upper limit of normal), or creatinine clearance ≥ 60 mL/min (using Cockcroft Gault formula) ; Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) : ≤ 2.5 × ULN (≤ 5 × ULN if liver metastases are present); Total bilirubin : ≤ 1.5 × ULN (except for patients with Gilbert’s Syndrome); Prothrombin time and activated partial thromboplastin time: ≤ 1.5 × ULN.
7. Adequate washout period before the first treatment as defined by:Major surgerytreatment involving removal of cancerous tissue and/or tumours and a margin of healthy tissue around it to reduce recurrence: ≥ 4 weeks. Radiation therapya treatment that uses controlled doses of radiation to damage or kill cancer cells: ≥ 4 weeks (≥ 2 weeks for palliative stereotactic radiation therapy without abdominal). Autologous transplantation: ≥ 3 months.

   Hormonal therapy: ≥ 2 weeks or per Investigator’s discretion for breast cancer patients.

   Chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells or targeted therapymedication that targets specific molecular features of cancer cells (including antibodya protein made by the immune system to fight against harmful substances (antigens), such as bacteria or viruses drug therapy): ≥ 3 weeks (≥ 2 weeks for 5 flourouracil-based agents, folinate agents, and/or weekly paclitaxel; ≥ 2 weeks (or 5 half-lives, whichever is shorter) for tyrosine kinase inhibitors; ≥ 4 weeks for HER2-directed biologic therapies; ≥ 6 weeks for nitrosoureas or mitomycin C). Immunotherapya treatment that uses a person's immune system to fight cancer: ≥ 4 weeks. Strong cytochrome P450 enzyme 3A4 (CYP3A4) inhibitor: ≥ 3 elimination half-lives . Any investigational agents or treatments: ≥ 4 weeks.

8. Patients without a history of acquired immunodeficiency syndrome (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.