EUCTR2022-000776-19-PL进行中（未招募）1 期
A Phase II, Multicentre, Open-label, Master Protocol to Evaluate the Efficacy and Safety of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination with Anticancer Agents in Patients with Advanced/Metastatic Solid Tumours (TROPION-PanTumor03)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 670
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
- •1- Male and female, = 18 years at the time of screening
- •2-Histologically or cytologically documented advanced or metastatic malignancy.
- •3- Eastern Cooperative Oncology Group performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing. All participants must provide an archival FFPE tumour sample or newly acquired FFPE tumour sample for tissue-based analysis (see Section 8.6.1.1 for further details).
- •4- All participants must provide an archival FFPE tumour sample or
- •newly acquired FFPE tumour sample for tissue-based analysis.
- •5- At least 1 lesion not previously irradiated that qualifies as a RECIST 1.1 target lesion at baseline and can be accurately measured at baseline as = 10 mm in the longest diameter (except lymph nodes, which must have short axis = 15 mm) with CT or MRI and is suitable for accurate repeated measurements. Substudy 3 (mCRPC) allows enrolment of participants with nonmeasurable (by RECIST 1.1) bone metastatic disease.
- •6- Adequate bone marrow reserve and organ function within 7 days before randomization/treatment assignment defined as:
- •-Haemoglobin = 9.0 g/dL (red blood cell/plasma transfusion or red blood cell stimulating factor, such as erythropoietin, is not allowed within 1 week prior to screening assessment)
- •-Absolute neutrophil count = 1.5 × 109/L (granulocyte colony stimulating factor administration is not allowed within 1 week prior to screening assessment).; pegylated granulocyte colony stimulating factor is not allowed within 2 weeks prior to screening assessment).
- •-Platelet count =100 × 109/L (platelet transfusion or platelet stimulating factor, such as thrombopoietin, is not allowed within 1 week prior to screening assessment).
- •-Serum albumin = 2.5 g/dL,
- •-International normalised ratio/prothrombin time and either partial thromboplastin time or activated partial thromboplastin time = 1.5 ×
- •-Total bilirubin = 1.5 × ULN or < 3 × ULN in the presence of documented
- •Gilbert's syndrome.
- •-Except in the setting of HBV, ALT and AST = 3 × ULN (< 5 × ULN in participants with liver metastases). See Exclusion Criterion 8 for
- •requirements in the setting of HBV.
- •-Calculated CrCL = 30 mL/min
- •7- Minimum life expectancy of 12 weeks.
- •8- At the time of screening, contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •9- All women of childbearing potential must have a negative pregnancy test (serum) documented during screening.
- •10- Female participants must be 1 year post-menopausal, surgically sterile, or using 1 highly effective form of birth control. Women of
- •childbearing potential must agree to use 1 highly effective method of birth control or avoid intercourse. They should have been stable on their chosen method of birth control for a minimum of 3 months before entering the study and continue for at least 7 months after the last dose of Dato-DXd. Starting at the time of first dose of Dato-DXd, female participants must not donate, or retrieve for their own use, ova at
- •any time during this study and for at least 7 months after the last dose of Dato-DXd.
- •Preservation of ova should be considered prior to enrolment in this study.
- •11- Male participants who intend to be sexually active with a female partner of childbearing potential must be surgically sterile, avoid
- •intercourse, or using a highly effective method of contraception from the time of screening throu
排除标准
- •1Any evidence of diseases such as QT prolongation and persistent toxicities associated with prior or current medication or previous anti-cancer therapy
- •2History of another primary malignancy except that treated with curative intent with no known active disease within 3 yrs before the first dose of study intervention and of low potential risk for recurrence 3Persistent toxicities caused by previous anticancer therapy, excluding alopecia, not yet improved to Grade=1 or baseline
- •4Participants with irreversible toxicity that is not reasonably expected to be exacerbated by study intervention in opinion of PI may be included (eg, hearing loss)
- •5Spinal cord compression or brain metastases unless treated, asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to randomisation/start of study intervention. A minimum of 2 weeks must have elapsed between the end of whole brain radiotherapy/stereotactic radiation and study enrolment
- •6Leptomeningeal carcinomatosis
- •7Clinically significant corneal disease
- •8Active hepatitis or uncontrolled hepatitis B or C virus infection
- •9Uncontrolled infection requiring IV antibiotics, antivirals or antifungals eg, prodromal symptoms
- •10Known HIV infection that is not well controlled
- •11Known to have active tuberculosis infection
- •12 Mean resting corrected QTcF > 470 ms, regardless of gender, obtained from triplicate 12-lead ECGs performed at screening.
- •13History of QT prolongation associated with other medications that required discontinuation of that medication, any current concomitant medication known to prolong the QT interval and cause TdP. Congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives.
- •14Significant cardiac diseases including:
- •MI or uncontrolled/unstable angina within 6 months before enrolment.
- •CHF (NYHA Class II to IV).
- •Cardiac arrhythmia, multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia, which is symptomatic or requires treatment (CTCAE Grade 3), symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Participants with atrial fibrillation controlled by medication or arrhythmias controlled by pacemakers may be permitted upon discussion with the study clinical lead.
- •Uncontrolled hypertension (resting systolic BP>180 mmHg or diastolic BP>110 mmHg)
- •15History of non-infectious ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
- •16Has severe pulmonary function compromised
- •17Prior exposure to chloroquine/hydroxychloroquine without an adequate treatment washout period of > 14 days prior to first dose
- •18Receipt of live, attenuated vaccine within 30 days prior to the first dose of the study intervention
- •19Prior exposure to the following anticancer therapies without an adequate treatment washout period prior to enrolment:Immunotherapy non-antibody-based therapy, retinoid therapy: = 2 weeks or 5 times the terminal elimination t1/2 of the chemotherapeutic agent, whichever is longer;= 6 weeks for nitrosoureas or mitomycin C. Antibody-based anticancer therapy: = 4 weeks
- •20Any concurrent anticancer treatment
- •21Palliative radiotherapy with a limited field of radiation within = 2 weeks or to more than 30% of the bone marrow within = 4 weeks before the first dose of study intervention
- •22Major surgical procedure o
研究者
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