ACTRN12622000513718撤回1 期
A Phase I, First-In-Human, Multicenter, Open-Label, Dose Escalation and Expansion Study of GQ1007 Alone and in Combination with Envafolimab in Subjects with HER2-expressing Advanced Solid Tumors
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Male and female subjects more than or equal to 18 years of age with a life expectancy of more than 3 months.
- •2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- •3. Left ventricular ejection fraction (LVEF) more than or equal to 50% by either echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 28 days before the first dose of study treatment.
- •4. Agrees to submit fresh tumor biopsy samples for biomarkers if any studied tumor is accessible.
- •5. Histologically or cytologically confirmed malignancy diagnosis and at least 1 measurable pathologically documented advanced/unresectable or metastatic solid tumor as assessed by RECIST 1.1.
- •6. Documented progressive disease, refractory to/intolerant of standard therapy, or there is no standard therapy.
- •7. Adequate organ function confirmed at screening and within 7 days before the first dose of study treatment as evidenced by platelet count (more than or equal to 100,000/mm3), hemoglobin (more than or equal to 8g/dl), Absolute neutrophil count (more than or equal to 1500/mm3), Serum creatinine (less than or equal to 1.5 × upper limit of normal[ULN], or estimated creatinine clearance more than or equal to 60 mL/min (Cockcroft-Gault formula), alanine transaminase and aspartate transaminase less than or equal to 2.5 × ULN (less than or equal to 5 × ULN if liver metastases are present), total bilirubin (less than or equal to 1.5 × ULN or less than or equal to 2 × ULN for subjects with Gilbert’s Syndrome), Prothrombin time and activated partial thromboplastin time (less than or equal to 1.5 × ULN).
- •8. Adequate washout period before the first treatment
- •-For any major surgery, radiation therapy, immunotherapy, and any investigational agents or treatments- more than or equal to 4 weeks,
- •-For autologous transplants - more than or equal to 3 months,
- •-For hormonal therapy - more than or equal to 2 weeks,
- •-For chemotherapy or targeted therapy- more than or equal to 2 weeks (for 5-flourouracil based agents, folinate agents, and/or weekly paclitaxel, tyrosine kinase inhibitors); more than or equal to 4 weeks for HER2-directed biologic therapies; more than or equal to 6 weeks for nitrosoureas or mitomycin C; more than or equal to 3 weeks for any other chemotherapy/targeted therapy.
- •Additional inclusion criteria for Part 1 and Part 3
- •9. Has the protocol specified malignancies such as breast cancer, gastric cancer, gastroesophageal junction cancer, urothelial cancer, salivary gland carcinoma, gallbladder carcinoma, cholangiocarcinoma, or non-small cell lung cancer.
- •Additional inclusion criteria for Part 2 and Part 4
- •10. Agrees to provide a HER2 test report from tumor biopsy performed within the past 6 months or an archived tumor sample collected within the past 6 months, and if neither is available, a fresh tumor biopsy to confirm HER2 status if any studied tumor is accessible.
- •Additional inclusion criteria for Part 2a
- •11. Has breast cancer with HER2 overexpression (immunohistochemistry [IHC] 3+ or [IHC 2+ and in situ hybridization]).
- •Additional inclusion criteria for Part 2b
- •12. Has breast cancer with HER2 low expression (immunohistochemistry [IHC] 2+ or ISH or IHC 1+). Subjects with HER2 low expression metastatic breast cancer who have exhausted treatments that can confer any clinically meaningful benefit are also eligible.
- •Additional inclusion criteria for Part 2c
- •13. Subject has either a solid malignant tumor with HER2 expression or HER2 mutatio
排除标准
- •1. Clinically active brain metastases, defined as untreated and symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms.
- •2. Conditions requiring systemic treatment with either corticosteroids (more than 10 mg daily prednisone equivalent) within 7 days or taking any other immunosuppressive medication within 14 days prior to the first dose of study treatment.
- •3. Active autoimmune disease that required systemic treatment (disease modifying agents, corticosteroids, or immunosuppressive drugs) within the past 2 years.
- •4. Prior organ or tissue allograft.
- •5. History of Grade 3 or higher toxicity related to prior T cell agonist or checkpoint inhibitor.
- •6. Poorly controlled diarrhea (e.g., watery stool, uncontrolled bowel movement with drugs, Grade more than or equal to 2 ).
- •7. Cardiovascular dysfunction or clinically significant cardiac disease.
- •8. Medical history of clinically significant lung disease.
- •9. Known hypersensitivity to either the drug substances or inactive ingredients in the drug product.
- •10. Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade 1 or less or baseline.
- •11. Cumulative anthracycline dose greater than 360 mg/m2 doxorubicin or equivalent.
- •12. Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.
- •13. Known human immunodeficiency virus (HIV) infection.
- •14. Active infection with hepatitis C or hepatitis B except that subjects with occult or prior hepatitis B infection may be included if Hepatitis B Virus's Deoxyribonucleic acid (DNA) is undetectable at the time of screening, and these subjects must be willing to monthly DNA testing and appropriate antiviral therapy as indicated.
- •15. A positive test result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by a certified nucleic acid test within the last 30 days before the first dose of study treatment.
- •16. Receipt of a live vaccine within 30 days prior to the first dose of study treatment.
- •17. Pregnant or lactating women
- •18. Unwilling to use adequate contraceptive methods during the study and for at least 7 months after the last dose of study tratments.
- •Additional exclusion criteria for Part 2 and Part 4
- •19. Subjects with multiple primary malignancies within 2 years, except adequately resected non-melanoma skin cancer, curatively treated in-situ disease, other solid tumors curatively treated, or contralateral breast cancer.
研究者
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