2023-508700-38-00已完成2 期
A Phase I-II, First-in-Human Study of SKB264 in Patients with Locally Advanced Unresectable /Metastatic Solid Tumors Who are Refractory to Available Standard Therapies
Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd.9 个研究点 分布在 2 个国家目标入组 31 人开始时间: 2024年6月17日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 9
- 主要终点
- ORR (the percentage of patients who achieve CR/PR) per RECIST 1.1
研究概览
简要总结
To evaluate the objective response rate (ORR) [Complete Response (CR) + Partial Response (PR)] of SKB264 when administered intravenously (IV) as monotherapy at the RDEs to patients with metastatic or locally advanced unresectable tumors.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Follow-up period
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Patients must be able to provide documented voluntary informed consent.
- •Creatinine clearance ≥ 30 mL/min calculated by Cockcroft-Gault, Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), or Modification of Diet in Renal Disease (MDRD) formulas. Note that 4-hour urine collection is not required but is allowed.
- •For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception during study treatment.
- •Patients must have recovered (i.e., improvement to Grade 1 or better) from all acute toxicities from previous therapy, excluding alopecia and vitiligo. Note: Subjects with endocrine AE of any grade are permitted to enroll if they are stably maintained on appropriate replacement therapy and are asymptomatic.
- •Expected survival ≥ 3 months.
- •ECOG Performance Status 0 or
- •Male or female patient aged ≥ 18 years.
- •Histologically or cytologically documented, incurable, locally advanced, recurrent or metastatic cancer.
- •Measurable disease by CT/MRI.
- •Patients should have an unresectable locally advanced or metastatic solid tumor that is refractory to standard therapies.
- •Neutrophil count ≥ 1.5×109/L, platelet count ≥ 100×109/L, and hemoglobin ≥ 9 g/dL (without receiving blood transfusion, erythropoietin, recombinant human thrombopoietin or colony stimulating factor treatment within 2 weeks before screening).
- •International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5×ULN.
- •Serum total bilirubin ≤ 1.5 ×ULN (Patients with known Gilbert disease who have serum total bilirubin level ≤ 3 ×ULN may be enrolled), aspartate aminotransferase (AST), alanine aminotransferase (ALT)≤ 2.5 × upper limit of normal (ULN), with the exception of patients with hepatic metastases (ALT and AST ≤ 5 × ULN).
排除标准
- •Any patient who was treated in the Phase I part of this study.
- •Severe or uncontrolled cardiac disease requiring treatment, congestive heart failure (New York Heart Association) III or IV, unstable angina pectoris that couldn’t be controlled by medication, history of myocardial infarction during the last 6 months, serious arrhythmias requiring medication (with exception of atrial fibrillation or paroxysmal supraventricular tachycardia).
- •Subjects with known meningeal metastases, brainstem metastases, spinal cord metastases and/or compression, or other active CNS metastases. For further details refer to protocol.
- •Patients with active second primary cancers (except for cured in situ nonmelanoma skin cancer and in situ cervical cancer with no relapse in the last 3 years, or other malignant cancers that have been cured and no evidence of recurrence).
- •Require supplemental oxygen for daily activities.
- •Documented Grade ≥ 2 peripheral neuropathy.
- •History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, corneal disease that prevents/delays corneal healing, macular degeneration.
- •Patients previously treated with TROP2 targeted therapies at any time for early stage or metastatic disease.
- •Left ventricular ejection fraction < 45% determined by echocardiogram or multiple-gated acquisition scan.
- •Resting QTcF > 480 msec at baseline.
- •Ascites requiring paracentesis >1 per week.
- •Any standard cancer therapy (e.g. chemotherapy, hormonal therapy, immunotherapy, biologic therapy treatment, etc.) within 4 weeks, or any small molecular tyrosine kinase inhibitor (TKI), radiotherapy or therapy with traditional Chinese medicines approved for anti-tumor treatment within 2 weeks before first infusion of study drug.
- •Symptomatic pleural effusion (< 90% oxygen saturation).
- •History of interstitial lung diseases (ILD) or non-infectious pneumonitis requiring steroid treatments, or current ILD/pneumonitis, or where ILD/pneumonitis cannot be ruled out by imaging at screening; severe pulmonary dysfunction caused by lung diseases.
- •New diagnosed thromboembolic events that requires therapeutic intervention over the last 6 months (patients with stable control of lower limb deep venous thrombosis are allowed).
- •Known allergic to any components of SKB264, including excipients (including polysorbate-20); or history of severe hypersensitivity to another biologic therapy.
- •The investigator considers other situations that patients are not appropriate to participate in this trial.For participants in the EU, this includes those who, in the opinion of the investigator, could benefit from existing alternative treatment options within the current ESMO ( European Society For Medical Oncology) guidelines for each indication and setting. For further details please refer to protocol.
- •Any major surgical procedure within 4 weeks of first infusion of study drug.
- •Diagnosed disease as below or active infection including: Hepatitis B/C or cirrhosis. With serious infections within 4 weeks prior to the first dose of study intervention (including but not limited to comorbidity, sepsis or severe pneumonia that require hospitalization) or concomitant infections requiring systemic antibiotic treatment within 2 weeks prior to the first dose of study intervention.
- •Have known prior positive test results or medical history for human immunodeficiency virus.
- •Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥100 mmHg) or diabetes.
- •Subjects who require use of strong inhibitors or inducers of CYP3A4 at least 14 days prior to and throughout Study. Use of strong inhibitors or inducers of CYP3A4 is not allowed in this Study.
- •Pregnancy or lactation.
- •Any experimental therapy within 4 weeks or 5 half-lives, whichever is shorter, of first infusion of study drug.
研究组 & 干预措施
-, FAMOTIDINE , NIZATIDINE , FAMOTIDINE, COMBINATIONS, ROXATIDINE , RANITIDINE , CIMETIDINE
Auxiliary
Participants receiving -, FAMOTIDINE , NIZATIDINE , FAMOTIDINE, COMBINATIONS, ROXATIDINE , RANITIDINE , CIMETIDINE
干预措施: - (Drug)
-
Auxiliary
Participants receiving -
干预措施: - (Drug)
结局指标
主要结局
ORR (the percentage of patients who achieve CR/PR) per RECIST 1.1
ORR (the percentage of patients who achieve CR/PR) per RECIST 1.1
次要结局
- Percentage of patients with adverse events, serious adverse events DOR.PFS (time frame: baseline to the end of the study).OS (time frame: baseline to the end of the study).Immunogenicity of SKB264.PK parameters for SKB264-ADC, SKB264-TAB, and free KL610023 payload.Levels of TROP2 expression in tumor tissue and correlation of those levels with responses.
研究者
Xiaoping Jin (PhD, Chief Medical Officer)
Scientific
Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd.
研究点 (9)
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