A Modular Phase I/IIa, Open-label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Ascending Doses of AZD5305 as Monotherapy and in Combination with Anti-cancer Agents in Patients with Advanced Solid Malignancies (PETRA) - D9720C00001

AstraZeneca AB0 个研究点目标入组 1,067 人开始时间: 2024年4月15日最近更新: 2024年7月22日

试验速览

阶段: 1 期
状态: 招募中
发起方: AstraZeneca AB
入组人数: 1,067

研究概览入排标准研究者记录与标识符相似试验

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

•Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses., Male patients must use a condom with spermicide with all sexual partners from screening to approximately 6 months after the last dose of AZD5305 IMP., Adequate organ and marrow function as defined by the protocol., For part B expansion cohorts: Provision of formalin-fixed and paraffin embedded (FFPE) tumour specimen is mandatory, where available, except if stated that it is optional in a specific Module., Other module specific criteria may apply., Age = 18 at the time of screening., Patients must have histological or cytological confirmation of advanced malignancy considered to be suitable for study treatment and meeting module specific eligibility criteria., Eastern Cooperative Oncology Group Performance status (ECOG) PS: 0-2 with no deterioration in the previous 2 weeks., Life expectancy = 12 weeks., Progressive cancer at the time of study entry., Patients must have evaluable disease as defined in module-specific criteria for Part A and Part B., Female subjects of childbearing potential: Must have negative pregnancy test result at screening and prior to each cycle administration of study treatment and must use at least one highly effective method of birth control plus a barrier method., Female subjects must not breastfeed and must not donate or retrieve ova for their own use, from screening to approximately 6 months after the last dose of study treatment with IMP.

排除标准

•Treatment with any of the following: a) Nitrosourea or mitomycin C within 6 weeks of the first dose of study treatment b) Any investigational agents or study drugs from a previous clinical study within 5 half-lives or 3 weeks (whichever is shorter) of the first dose of study treatment c) Any other anticancer treatment within the time periods to the first dose of study treatment as indicated in the protocol d) Any live virus or bacterial vaccine within 28 days of the first dose of study treatment., Patients with any known predisposition to bleeding., Any of the following cardiac criteria; a) Mean resting corrected QT interval (QTcF) > 450 milliseconds or QTcF<340 milliseconds b) Any factors that increase the risk of QT prolongation, shortening or risk of arrhythmic events, congenital long or short QT syndrome, family history of long QT syndrome, familial short QT syndrome or unexplained sudden death under 40 years of age or any concomitant medication c) Known to prolong or shorten the QT interval d) Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG and clinically significant sinus node dysfunction not treated with pacemaker., Other cardiovascular diseases as defined by any of the following; a) Symptomatic heart failure b) Uncontrolled hypertension c) Hypertensive heart disease with significant left ventricular hypertrophy d) Acute coronary syndrome (ACS)/acute myocardial infarction (AMI), unstable angina pectoris, coronary intervention procedure with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within 6 months e) Cardiomyopathy of any etiology f) Presence of clinically significant valvular heart disease g) History of atrial or ventricular arrhythmia requiring treatment; subjects with atrial fibrillation/flutter and optimally controlled ventricular rate (<100 beats per minute) are permitted h) Transient ischaemic attack, or stroke within 6 months prior to screening i) Patients with symptomatic hypotension at screening., Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of myelodysplastic syndrome (MDS)/acute myeloid leukaemia (AML)., Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of AZD5305., Known allergy or hypersensitivity to investigational product(s) or any of the excipients of the investigational product(s)., Any concurrent therapy anti-cancer therapy or concurrent use of prohibited medications., Judgment by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements., Any condition that, in the investigator's opinion, would interfere with evaluation of the study treatment or interpretation of subject safety or study results., Concurrent enrolment in another clinical study, unless it is an observational (non interventional) clinical study or during the follow-up period of an interventional study., Concomitant use of medications or herbal supplements known to be cytochrome P450 3A4 (CYP3A4) strong and moderate inhibitors or inducers., Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site., Previous study treatment assignment in the present study., Uncontrolled intercurrent illness within the last 12 months., Pr

研究者

发起方

AstraZeneca AB

相似试验

招募中

1 期

Study of AZD5305 as monotherapy and with anti-cancer agents in patients with advanced solid malignancies

EUCTR2020-002688-77-CZAstraZeneca AB864

进行中（未招募）

1 期

Study of AZD5305 as monotherapy and with anti-cancer agents in patients with advanced solid malignanciesAdvanced Solid TumorsMedDRA version: 21.0Level: LLTClassification code 10048683Term: Advanced cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

EUCTR2020-002688-77-PLAstraZeneca AB1,067

招募中

1 期

Study of AZD9574 as monotherapy and in combination with anti-cancer agents in patients with advanced solid malignanciesModule 2: IDH-mutant glioma, Module 3: advanced/relapsed HER2-negative breast, ovarian, prostate, or pancreatic cancer and expressing BRCA1m, BRCA2m, PALB2m, RAD51Cm or RAD51Dm, IDH-mutant recurrent glioma, breast cancer (without BM), Module 1: advanced/relapsed ovarian, breast, pancreatic or prostate cancer where patients loss of function or predicted loss of function mutation in BRCA1, BRCA2, PALB2, RAD51C, or RAD51DMedDRA version: 20.0Level: PTClassification code: 10033128Term: Ovarian cancer Class: 100000004864MedDRA version: 20.0Level: PTClassification code: 10006187Term: Breast cancer Class: 100000004864MedDRA version: 20.0Level: PTClassification code: 10060862Term: Prostate cancer Class: 100000004864MedDRA version: 27.0Level: PTClassification code: 10063157Term: Metastatic glioma Class: 100000004864MedDRA version: 21.0Level: LLTClassification code: 10033604Term: Pancreatic cancer Class: 10029104

CTIS2023-504984-17-00AstraZeneca AB163

进行中（未招募）

1 期

Study of AZD9574 as monotherapy and in combination with anti-cancer agents in participants with advanced solid malignanciesModule 1: advanced/relapsed ovarian, breast, pancreatic or prostate cancer where patients loss of function or predicted loss of function mutation in BRCA1, BRCA2, PALB2, RAD51C, or RAD51DMdoule 2: IDH-mutant gliomaModule 3: advanced/relapsed HER2-negative breast, ovarian, prostate,or pancreatic cancer and expressing BRCA1m, BRCA2m, PALB2m,RAD51Cm or RAD51Dm, IDH-mutant recurrent glioma, breast cancer(without BM)MedDRA version: 20.0Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: LLTClassification code 10033604Term: Pancreatic cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: PTClassification code 10063157Term: Metastatic gliomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

EUCTR2021-006227-17-SEAstraZeneca AB270

进行中（未招募）

1 期

A study to assess AZD4573 in novel combination with acalabrutinib in participants with relapsed or refractory diffuse large B-cell lymphoma.Haematological MalignanciesMedDRA version: 21.1Level: PTClassification code 10066476Term: Haematological malignancySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

EUCTR2020-001642-18-ESAstraZeneca AB78