EUCTR2020-002719-23-FR进行中（未招募）1 期
BT8009-100: Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT8009 in Patients with Nectin-4 Expressing Advanced Malignancies
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 146
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients must meet the following criteria in order to be included in the research study:
- •1.Written informed consent, according to local guidelines, signed and dated by the patient or by a legal guardian prior to the performance of any study-specific procedures, sampling, or analyses.
- •2.At least 18 years-of-age at the time of signature of the informed consent form.
- •3.Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
- •4.Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- •5.Acceptable organ function, as evidenced by the following laboratory data:
- •a.Renal function, as follows: creatinine clearance of =50 mL/min by the Cockcroft-Gault equation or equivalent.
- •b.Total bilirubin =1.5 × ULN (upper limit of normal)
- •c.Serum albumin =2.5 g/dL
- •d.Aspartate aminotransferase (AST) =2.5 × ULN or =5 × ULN in the presence of liver metastases
- •e.Alanine aminotransferase (ALT) =2.5 × ULN or =5 × ULN in the presence of liver metastases
- •f.International normal ratio (INR) <1.3 or = institutional ULN
- •6.Acceptable hematologic function (no red blood cell or platelet transfusions or growth factors are allowed within 4 weeks of the first dose of BT8009):
- •a.Hemoglobin =9 g/dL
- •b.Absolute neutrophil count (ANC) =1500 cells/mm3
- •c.Platelet count =75,000 cells/mm3
- •7.Negative pregnancy test for women of childbearing potential (WOCBP) (negative serum test at screening and negative urine or serum test within 3 days prior to the first dose of BT8009).
- •8.Availability of archived tumor samples or willingness to provide fresh tumor biopsy during screening.
- •9.Life expectancy =12 weeks after the start of BT8009 treatment according to the Investigator’s judgment.
- •10.Must be willing and able to comply with the protocol, the scheduled visits, treatment plan, study restrictions, laboratory tests, contraceptive guidelines, and other study procedures.
- •11.Must have exhausted all standard treatment options, including appropriate targeted therapies, for example, EGFR or ALK therapies for relevant oncogene driver NSCLC patients.
- •Additional Inclusion Criteria – Part A Only
- •12.Patients with the following advanced, histologically confirmed malignant solid tumors that recurred after or have been refractory to previous therapy: a) urothelial (transitional cell) carcinoma (fresh biopsy or an archived sample must be submitted); orb) having pancreatic, breast, non-small-cell lung cancer (NSCLC), gastric, esophageal, head and neck, or ovarian tumor tissue (fresh biopsy or an archived sample) testing positive for Nectin-4 expression.
- •Exceptions: single-subject accelerated cohorts may enroll patients with advanced solid tumors not-restricted to the above definitions, unless the SRC views otherwise. The Sponsor may require a) or b) at any time during the enrollment; eligibility will be confirmed by the Medical Monitor. The Sponsor and/or SRC may decide to require enrollment of specific tumor (sub)types at any point during the escalation to enrich the evaluation of biomarkers, safety, anti-tumor activity, or PK.
- •Additional Inclusion Criteria – Part B-1 and B-2 Nectin-4 basket monotherapy and combination cohorts
- •13.Patients with solid tumor metastatic recurrent disease confirmed as Nectin-4 positive on fresh biopsy or archived tissue must have failed at least one prior line of therapy with evidence of radiographic progression on the most recent line of therapy. If patien
排除标准
- •1. Chemotherapy treatment =14 days prior to first dose, other anticancer treatments, treatment =28 days or 5 terminal half-lives, whichever is shorter. Prior toxicities must have resolved to Grade 1 per CTCAE v 5.0 (except alopecia, which must be no greater than Grade 2)
- •2. Experimental treatments =4 weeks of first dose
- •3. Prior treatment with Nectin-4 targeted therapy
- •4. Current treatment with strong inhibitors or strong inducers of CYP3A4 or strong inhibitors of P-gp, including herbal or food-based.
- •5. Known sensitivity to any of the ingredients in the product
- •6. BSA >2.21 m2.
- •7. Significant medical condition, including but not limited to eye (conditions related to or that may confound monitoring for dry eye, corneal opacities or keratitis), skin (conditions related to or that may confound monitoring for rash including but not limited to autoimmune conditions such as eczema or psoriasis), life-threatening illness, active uncontrolled infection or organ system dysfunction, or other reasons which, in the Investigator opinion, could compromise the patient’s safety, or interfere with or compromise the integrity of the study, including consideration of GI, skin and pulmonary co-morbidities and including review of screening chest CT to ensure no clinically significant co-morbidities. Prior = Grade 2 thyroid endocrinopathy is allowed, if appropriately controlled with thyroid hormone and stable for at least 2 months on therapy.
- •8. Clinically relevant troponin elevation (considering local reference standards)
- •9. Uncontrolled diabetes (HbA1c =8%)
- •10. Major surgery (excluding placement of vascular access) =4 weeks of first dose and recovered adequately prior to starting
- •11. Receipt of live/attenuated vaccine =30 days
- •12. Uncontrolled, symptomatic brain metastases (must have stable neurologic status following local therapy for >4 weeks without steroids or on stable or decreasing dose of =10 mg daily prednisone or equiv. at start of treatment and must be without neurologic dysfunction that would confound the evaluation of neurologic/other AEs).
- •13. Patients with uncontrolled hypertension (systolic BP =160 mmHg or diastolic BP =100 mmHg)
- •14. Any condition, therapy or lab abnormality that might confound results of study, interfere with patient’s participation, or is not in the best interest of the patient in the opinion of the PI, including but not limited to: history of a cerebral vascular event (stroke or TIA), unstable angina, myocardial infarction, CHF or symptoms of NYHA Class III-IV documented =6 months prior to first dose or: a) mean resting corrected QT interval (QTcF) >470 msec, b) any factors that increase the risk of QTc prolongation or risk of arrhythmic events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years-of-age, or any concomitant medication known to prolong the QT interval, or c) any clinically important abnormalities in rhythm, conduction, or morphology of resting ECGs, e.g., complete left bundle branch block, third-degree heart block.
- •15.Known HIV or AIDS
- •16.Patients with a positive hepatitis B surface antigen and/or anti-hepatitis B core antibody. Patients with a negative polymerase chain reaction (PCR) assay are permitted with appropriate antiviral therapy.
- •17.Active hepatitis C infection with positive viral load if hepatitis C virus (HCV) antibody positive (if antibody is negative, then viral load not applicable). Patie
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