A Modular Phase I/IIa, Open-label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of AZD0516 as Monotherapy and in Combination with Anti-cancer Agents in Participants with Metastatic Prostate Cancer (SEACLIFF) (SEACLIFF)

未提供0 个研究点目标入组 8 人开始时间: 待定

适应症

试验速览

阶段: 不适用
状态: 招募中
入组人数: 8

研究概览研究设计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
分配方式: Randomized

入排标准

年龄范围: 18age old over 至 No limit（—）
性别: All

入选标准

•Histologically or cytologically confirmed diagnosis of metastatic adenocarcinoma of the prostate. Focal high grade neuroendocrine features are permitted.
•Measurable PSA 1 mcg/L or more (1 ng/mL or more).
•Surgically or medically castrated with serum testosterone levels 50 ng/dL or less (1.75 nmol/L or less) within 28 days or less before treatment allocation. Ongoing androgen deprivation therapy (ADT) with a gonadotropin releasing hormone (GnRH) modulator for participants who have not undergone bilateral orchiectomy must be initiated at least 2 weeks prior to consent and must continue throughout the study.
•Eastern cooperative oncology group (ECOG) performance status of 0 or
•Adequate organ and marrow function in the absence of blood transfusion or growth factor support (within 21 days prior to the scheduled first dose of study intervention).
•Provision of baseline archival or newly obtained formalin-fixed paraffin-embedded (FFPE) tumour sample is mandatory.
•Documented current evidence of metastatic prostate cancer
•Documented mCRPC progression at screening as assessed by the investigator with at least one of the following criteria:
•PSA progression defined by a minimum of 3 rising PSA levels with an interval of or more 1 week between each determination. The PSA value at the screening visit should be 1 mcg/L or more (1 ng/mL).
•Radiographic disease progression in soft tissue based on response evaluation criteria in solid tumors (RECIST) v1.1 criteria with or without PSA progression as per prostate cancer working group 3 (PCWG3).
•Radiographic disease progression in bone defined as the appearance of 2 or more new bone lesions on a bone scan as per PCWG3 with or without PSA progression.

排除标准

•Cancer related spinal cord compression, or brain metastases unless asymptomatic, treated and stable and not requiring continuous corticosteroids at a dose of more 10 mg prednisone/day or equivalent for at least 4 weeks prior to study enrolment.
•History of leptomeningeal carcinomatosis.
•Unresolved toxicities of Grade 2 or more (National Cancer Institute Common Terminology Criteria for Adverse Events v5.0) from prior therapy (excluding vitiligo, alopecia, and endocrine disorders that are controlled with replacement hormone therapy).
•Uncontrolled intercurrent illness within the last 12 months.
•Cardiovascular disorder (History of arrhythmia, uncontrolled hypertension, symptomatic hypotension, history of brain perfusion problems, symptomatic heart failure, prior or current cardiomyopathy, severe valvular heart disease)
•History of malignancy
•History of non-infectious interstitial lung disease (ILD)/pneumonitis
•Active infection exclusions, including tuberculosis and infections with Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV).
•Any known predisposition to bleeding
•Clinically severe pulmonary compromise
•Participants with Myelodysplastic syndrome (MDS)/Acute Myeloid Leukemia (AML) or with features suggestive of MDS/AML.
•Previous treatment with a STEAP2 targeting modality, chemotherapeutic agent that inhibits topoisomerase activity or metabolic enzymes.

研究者

发起方

未提供

相似试验

招募中

不适用

Anti-Ly6E Exatecan ADC M7437 in Advanced Solid TumorsAdvanced Solid Tumors

jRCT203125067815

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

招募中

1 期

Study of AZD5305 as Monotherapy and with Anti-Cancer Agents in Patients with Advanced Solid Malignancies

CTIS2022-502856-29-00AstraZeneca AB1,067

招募中

不适用

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)

jRCT2031210609Astrazeneca K.K804