EUCTR2022-000776-19-FR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)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 541
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
- 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. Archival FFPE tumour samples must be < 12 months old from the time of collection to the time of start of protocol screening. The exception is for gastric Substudy Cohorts 2A and 2B, where prospective PD-L1 central testing is required for enrolment, archival FFPE tumour samples must be < 6 months old from the time of collection to the time of start of protocol.
- •4- 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.
- •5- Adequate bone marrow reserve and organ function within 7 days before randomization/treatment assignment defined as:
- •-Haemoglobin = 9.0 g/dL
- •-Absolute neutrophil count = 1.5 × 109/L
- •-Platelet count =100 × 109/L (platelet transfusion 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 × ULN.
- •-Total bilirubin = 1.5 × ULN if no liver metastases or < 3 × ULN in the presence of documented Gilbert’s syndrome or liver metastases at baseline.
- •-ALT and AST = 3 × ULN (< 5 × ULN in participants with liver metastases).
- •-Calculated CrCL = 30 mL/min
- •6 Minimum life expectancy of 12 weeks.
- •7- 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.
- •8- Negative pregnancy test (serum) for women of childbearing potential who are sexually active with a non-sterilised male partner.
- •9- Female participants must be 1 year post-menopausal, surgically sterile, or using 1 highly effective form of birth control. Women of childbearing potential who are sexually active with a non-sterilised male partner must agree to use 1 highly effective method of birth control. 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.
- •10- Male participants who intend to be sexually active with a female partner of childbearing potential must be surgically sterile or using a highly effective method of contraception from the time of screening throughout the total duration of the study and for drugs that are potentially genotoxic the drug washout period (at least 4 months after the last dose of study intervention) to prevent pregnancy in a partner. Male participants must not donate or bank sperm during this same time period.
- •11-Capable of giving signed informed consent
- •12 Provision of signed and dated written Optional Genetic Research Information informed consent prior to collection of sample for optional genetic research that supports Genomic Initiative.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this
排除标准
- •1-Any evidence of diseases such as QT prolongation and persistent toxicities associated with prior or current medication or previous anti-cancer therapy
- •2-History of another primary malignancy except that treated with curative intent with no known active disease within 3 years before the first dose of study intervention and of low potential risk for recurrence
- •3-Persistent toxicities caused by previous anticancer therapy, excluding alopecia, not yet improved to Grade = 1 or baseline
- •4-Participants with irreversible toxicity that is not reasonably expected to be exacerbated by study intervention may be included (eg, hearing loss) after consultation with the AstraZeneca study clinical lead
- •5-Spinal 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
- •6-Leptomeningeal carcinomatosis
- •7-Clinically significant corneal disease
- •8-Active hepatitis or uncontrolled hepatitis B or C virus infection
- •9-Uncontrolled infection requiring IV antibiotics, antivirals or antifungals eg, prodromal symptoms
- •10- Known HIV infection that is not well controlled
- •11-Known to have active tuberculosis infection
- •12- Mean resting corrected QTcF > 470 ms, regardless of gender, obtained from triplicate 12-lead ECGs performed at screening.
- •13- History 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.
- •14-Significant cardiac diseases including:
- •- Myocardial infarction or uncontrolled/unstable angina within 6 months before enrolment.
- •- Congestive heart failure (New York Heart Association 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 blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg)
- •15-History 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
- •16-Clinically severe pulmonary function (ie, pulmonary emboli within 3 months prior to study enrolment, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion etc); or any autoimmune, connective tissue or inflammatory disorders (ie, rheumatoid arthritis, Sjögren’s syndrome, sarcoidosis, etc)
- •17-Prior exposure to chloroquine/hydroxychloroquine without an adequate treatment washout period of > 14 days prior to first dose
- •18-Receipt of live, attenuated vaccine within 30 days prior to the first dose of the study intervention
- •19-Prior exposure to the following anticancer therapies without an adequate treatment washout period prior to enrolment:
- •Immunotherapy n
研究者
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