A Study of GQ1010 in Subjects With Advanced Solid Tumors

Inclusion Criteria

• •1. Male or female, ≥18 years old.
• •2. Is able to provide written informed consent and is willing and able to comply with the protocol prior to initiation of any study-related tests or procedures.
• •3. Has a life expectancy of ≥ 3 months.
• •4. With histologically or cytologically confirmed locally advanced or metastatic solid malignant tumors with epithelial derived malignancy has relapsed or progressed following local standard treatments, or for which no standard treatment is available. Priority for inclusion but not limited to the following types of cancer: gastric adenocarcinoma/gastroesophageal junction cancer, breast cancer (triple negative and hormone receptor-positive, HER2 negative), colorectal cancer, cholangiocarcinoma, pancreatic cancer, endometrial cancer, ovarian cancer, cervical cancer, etc.
• •5. Agreed to provide archived tumor tissue specimens (unstained 10 surgical specimens \[thickness 4-5μm\] was suggested or fresh tissue samples of primary or metastatic sites within 3 years.
• •Note: Trop-2 expression was not used to confirm participant eligibility; Tissue samples will be used for subsequent analysis of Trop-2 expression levels and other biomarkers.
• •6. Measurable tumor lesion based on Response Evaluation Criteria in Solids Tumors (RECIST) version 1.1.
• •7. Subjects had confirmed disease progression during or after the most recent treatment for locally advanced or metastatic disease, or subjects would not benefit from the former treatment assessed by the investigator .
• •8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• •9. If of reproductive/child-bearing potential(male and female) must agree to use reliable contraceptive measures (include hormonal contraceptives, barrier contraception or abstinence) with their partners during and upon completion of the study and for at least 7 months after the last dose of study drug.
• •10. Has adequate bone marrow reserve and organ function (no transfusion or hematopoietic-stimulating factor therapy within 14 days):
• •* Hemoglobin (HGB) ≥ 9 g/dl
• •* Absolute neutrophil count (ANC) ≥ 1,500/mm3,
• •* Platelet count (PLT) ≥ 100,000/mm3,.
• •* Serum creatinine ≤ 1.5 × ULN or creatinine clearance (Ccr) ≥ 50 ml/min (calculated according to the cockcroft-gault formula),
• •* Total bilirubin (TBIL) ≤ 1.5 × ULN (gilbert's syndrome, TBIL ≤ 3 × ULN),
• •* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × ULN (with liver metastases ≤ 5.0 × ULN)
• •* International normalized ratio of prothrombin (INR) ≤ 1.5 × ULN, or prothrombin time (PT) ≤ 1.5 × ULN,
• •* Activated partial thromboplastin time (APTT) ≤1.5 × ULN. Subjects receiving anticoagulant therapy must have INR and/or APTT≤ the upper limit of the therapeutic range intended for use,
• •* Left ventricular ejection fraction ≥50% by echocardiography
• •11. Has an adequate treatment washout period prior to initial treatment.
• •12. 3a: Has a pathologically documented HER2 negative (IHC 2+ and ISH\* - or ISH unknown, or IHC 1+) advanced/unresectable or metastatic gastric adenocarcinoma/gastroesophageal junction carcinoma(GC/GJC) that relapsed or progressed after standard therapy (at least first-line chemotherapy with or without immune checkpoint inhibitor), or no standard therapy available. Those who relapsed/progressed within 6 months of prior adjuvant/neoadjuvant systemic therapy are not required to receive an additional line of therapy in order to be eligible.
• •13. 3b: Has a pathologically documented advanced/unresectable or metastatic triple negative breast cancer(TNBC) that relapsed or progressed after standard treatment (at least first-line chemotherapy), or no standard treatment available. Subjects with HER2 low expression who have progressed after treatment with anti-HER2-ADC (such as T-DXd) are admitted.
• •14. 3b: Has a pathologically documented advanced, or unresectable, or metastatic HER2 negative(IHC2+ with ISH\*- or ISH unknown, or IHC1+) HR+BC, is documented refractory or resistant to standard therapy (Was previously treated with a minimum of 1 and a maximum of 4 prior lines of chemotherapy in the advanced/metastatic setting), or no standard therapy available :
• •* All subjects must have previously received antitumor endocrine therapy, CDK-4/6 inhibitor therapy, and taxanes;
• •* Those who relapsed/progressed within 12 months of prior adjuvant/neoadjuvant systemic therapy are not required to receive an additional line of therapy in order to be eligible.;
• •* Subjects with HER2 low expression who have progressed after treatment with anti-HER2-ADC (such as T-DXd) are admitted.
• •15. 3c: Has a pathologically documented advanced, unresectable, or metastatic colorectal cancer is documented refractory or resistant to standard treatment (at least 2 prior lines systemic therapy, including 5-FU-based chemotherapy and anti-VEGF or anti-EGFR-mAb therapy), or no standard therapy available.
• •• Has not progressed or relapsed within 3 months of therapy with irinotecan.
• •16. 3d: Has a pathologically documented advanced/unresectable or metastatic cervical cancer or endometrial cancer that relapsed or progressed after standard therapy (at least first-line chemotherapy with or without immune checkpoint inhibitor), or no standard therapy available.
• •17. 3d: Pathologically documented unresectable or metastatic platinum-resistant ovarian cancer that has relapsed or progressed within 6 months of platinum-based chemotherapy, or no standard therapy available. .
• •18. 3d: Pathologically documented unresectable or metastatic platinum-sensitive ovarian cancer that has relapsed or progressed at least 6 months after the most recent platinum-based chemotherapy , or no standard therapy available. .
• •19. 3e: Has a pathologically documented advanced/unresectable or metastatic Biliary tract carcinoma(BTC) that relapsed or progressed after standard therapy (at least first-line chemotherapy with or without immune checkpoint inhibitor), or no standard therapy available.
• •20. 3e: Has a pathologically documented unresectable or metastatic Head and neck squamous cell carcinoma(HNSCC) that relapsed or progressed after at least 1 prior lines of therapy including chemotherapy and ICI or EGFR mAb (in combination or sequential ), or no standard therapy available.
• •21. 3e: Has a pathologically documented unresectable or metastatic pancreatic cancer that relapsed or progressed after least 1 prior line of systemic therapy, or no standard therapy available. Those who relapsed/progressed within 6 months of prior adjuvant/neoadjuvant systemic therapy are not required to receive an additional line of therapy in order to be eligible. And has not progressed or relapsed within 3 months of therapy with irinotecan.