CTIS2024-511074-80-01进行中（未招募）1 期
A multicenter, first-in-human, dose escalation and optimization phase I/IIa study to investigate safety, tolerability, pharmacokinetics, and efficacy of the NaPi2b antibody-drug conjugate TUB-040 in patients with platinum-resistant high-grade ovarian cancer (PROC) or relapsed/refractory adenocarcinoma non-small cell lung cancer (NSCLC) (NAPISTAR 1-01). - NAPISTAR 1-01
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Tubulis GmbH
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Patients with OC: Histologically confirmed high-grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer, All patients: Radiologically measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, that includes at least 1 lesion not previously irradiated; see Appendix G of protocol, All patients: Eastern Cooperative Oncology Group (ECOG) 0-1; see Appendix A of protocol., All patients: Have a life expectancy of more than 12 weeks for disease-related mortality, as evaluated by the INV., All patients: Patients must be willing to sign an archival tissue release form for research purposes and determination of biomarker (e.g., NaPi2b) expression. The patient must have an adequate tumor tissue sample available for biomarker assessment by the central laboratory. Mandatory is either a tissue (FFPE) block or a minimum of 6 freshly cut sections based on the most recently available tumor sample. If no archival specimens are available, a newly acquired biopsy specimen must be taken., All patients: Patients must be willing to undergo a non-contrast high-resolution HRCT of the thorax scan and pulmonary function testing (PFT) at screening., All patients: Adequate organ function, as defined by the following criteria assessed during the screening period: a) Aspartate aminotransferase / serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase / serum glutamic pyruvate transaminase (ALT/SGPT) = 3.0 x upper limit of normal (ULN). b) Total serum bilirubin = 1.5 x ULN (CTCAE Grade = 1) unless secondary to Gilbert´s syndrome. Patients with Gilbert´s syndrome may be included if their unconjugated bilirubin is = 3 x ULN. c) Creatinine clearance >60 ml/min either measured or calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula. d) Alkaline phosphatase (ALP) < 2.5 x ULN, except if there is an alternative explanation for ALP elevation rather than hepatic failure, such as the presence of bone metastasis. e) Hemoglobin =8.0 g/dL (without support by red blood cell transfusion or growth factors), negative Coombs test. f) Absolute neutrophil count =1500/mm3 (without G-CSF support). g) Platelet count =100,000mm3 (=100 G/l)(without support by platelet transfusions). h) International normalized ratio (INR) = 1.5 and activated partial thromboplastin time (aPTT) = 1.5 × ULN in the absence of anticoagulation therapy. If patients are on anticoagulation therapy, INR should be within the therapeutic range for the medical indication., All patients: Resolution of all acute toxic effects of prior therapy or surgical procedures to =Grade 1 (except alopecia, hyperpigmentation, or discoloration [including vitiligo] of the skin and nails, stable immune-related toxicity such as hypothyroidism on hormone replacement, adrenal insufficiency on =10 mg daily prednisone [or equivalent], chronic Grade 2 peripheral sensory neuropathy after a prior therapy with taxane)., All patients: Patients of childbearing potential (FCBP) who are sexually active with a non-sterilized partner must use at least one highly effective method of contraception from the time of screening and must agree to continue using such precautions until the end of exposure, plus 5 half-lives and 6 months add-on in the case of patients assigned female at birth. Abstinence is acceptable only as true abstinence when this is in line with the preferred and usual lifestyle of the patient for the duration of the study treatment and the
排除标准
- •Patients with OC: Patients with low-grade OC or any grade non-serous OC., All patients: History of hypersensitivity to exatecan or excipients of the TUB-040 formulation., All patients: Disease that is refractory to topoisomerase-I inhibitors, defined as progression during or within 6 months of last infusion, including ADCs with deruxtecan, exatecan, or camptothecan as a payload., All patients: Patients with spinal cord compression or active central nervous system disease., All patients: Patients are not allowed to participate in interventional clinical studies either concurrently or within the previous 28 days or within 5 half-lives of any investigational pharmacologic agents or imaging materials, including dyes, investigational surgical techniques, or devices., All patients: Prior radiotherapy < 2 weeks from trial inclusion., All patients: Major surgery within 21 days prior to signing the ICF, unless the patient is recovered at that time., All patients: Has a history of non-infectious ILD/pneumonitis/radiation pneumonitis that required steroids or has current ILD/pneumonitis., All patients: Has an oxygen saturation of <93% on room air at rest., All patients: Has a forced vital capacity <60% and diffusing capacity of the lung for carbon monoxide <70%., All patients: Has a QTcF >470 ms, Patients with OC: Patients with primary platinum refractory OC, All patients: History of nephrotic syndrome, All patients: Active corneal disease, or history of corneal disease within 12 months prior to enrollment., All patients: Active, uncontrolled impairment of the urogenital, renal, hepatobiliary, cardiovascular, gastrointestinal, neurologic or hematopoietic systems which, in the opinion of the INV, would predispose the patient to the development of complications from the administration of protocol therapy., All patients: History of another malignancy with ongoing treatment or not yet free from disease for 2 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or other malignancy with a similar expected curative outcome., All patients: Documented other concurrent non-malignant comorbidities such as unstable or uncontrolled pectoral angina, myocardial infarction during the last 6 months, valvular heart disease that requires treatment, acute myocarditis, or congestive heart failure (CHF) (New York Heart Association III or IV)., All patients: Any concurrent chemotherapy, radiotherapy (except for local radiation therapy of lesions that may cause imminent complications), immunotherapy or corticoid therapy, other than that permitted in Section 8.7 of the protocol., All patients: Live vaccines within 30 days prior to study entry., All patients: Patients with acute or chronic infections such as: a) Patients who are HBsAg positive are eligible if they have received HBV anti-viral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization. Note: Patients should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post-completion of study intervention. b)Patients with history of HCV infection are eligible if HCV viral load is undetectable at screening. Note: Patients must have completed curative anti-viral therapy at least 4 weeks prior to enrollment. c) HIV infected patients must be on anti-retroviral therapy (ART) and have a well-controlled HIV infection/disease defined in Section 7.2.3 of the protocol. d) Any other known
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