JPRN-jRCT2031230577招募中1 期
This is a first time in human (FTiH) Phase I/IIa, open-label, multi-centre study of AZD3470 in participants with advanced or metastatic solid tumours with MTAP deficiency. The study consists of several study modules, evaluating the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of AZD3470 as monotherapy or in combination with other anti-cancer agents.
Hibi Kazushige0 个研究点目标入组 19 人开始时间: 2024年1月18日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 19
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Participant must be at least 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place,at the time of signing the ICF.
- •- Willing to provide archival and/or baseline tumour sample to meet the minimum tissue requirement for central MTAP deficiency testing.
- •- Participants must have received and progressed, are refractory or are intolerant to standard therapy for the specific tumour type. All participants are required to have had at least one prior line of treatment in the recurrent or metastatic setting.
- •- MTAP deficient tumours defined as evidence of homozygous deletion of one or more exons of the MTAP gene in tumour tissue AND/OR loss of MTAP expression in the tumour tissue.
- •- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- •- A minimum life expectance of 12 weeks in the opinion of the Investigator.
- •- Participants must have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1
- •- Adequate organ and bone marrow reserve function.
- •- Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
排除标准
- •- Spinal cord compression or symptomatic and unstable brain metastases or leptomeningeal disease.
- •- Allogenic organ transplantation.
- •- Any significant laboratory finding or any severe and uncontrolled medical condition.
- •- Any of the following cardiac criteria:
- •LVEF 50% or less
- •_ prior or current cardiomyopathy
- •_ clinically active cardiovascular disease, or a history of myocardial infarction within the last 6 months
- •_ uncontrolled angina or acute coronary syndrome within 6 months
- •_ severe valvular heart disease
- •_ uncontrolled hypertension
- •_ risk of brain perfusion problems. Stroke or transient ischemic attack in the last 6 months, undergone coronary artery bypass graft, angioplasty or vascular stent
- •_ chronic heart failure
- •_ factors that increase the risk of QTc prolongation or risk of arrhythmic events
- •- Mean resting QTcF > 470 msec or any clinically important abnormalities in rhythm
- •- Use of therapeutic anti-coagulation for treatment of active thromboembolic events.
- •- Serologic active hepatitis B or C infection.
- •- Known to have tested positive for Human immunodeficiency virus (HIV).
- •- Confirmed or suspected ILD/pneumonitis or history of (non-infectious) ILD/pneumonitis that required oral or IV steroids or supplemental oxygen
- •- Active gastrointestinal disease or other condition that would interfere with oral therapy.
- •- History of another primary malignancy.
- •- Unresolved toxicities from prior anti-cancer therapy, except alopecia and neuropathy.
- •- Prior treatment with a protein arginine methyltransferase 5 (PRMT5) inhibitor.
研究者
相似试验
招募中
1 期
Safety, efficacy, immunogenicity study of GSK Biologicals’ HBV viral vector and adjuvanted proteins vaccine (GSK3528869A) in adult patients with chronic Hepatitis B infection.Hepatitis B, ChronicCTIS2023-510020-68-00GlaxoSmithKline Biologicals115
进行中（未招募）
1 期
A study to evaluate the reactogenicity, safety, immunogenicity and efficacy of GlaxoSmithKline (GSK) Biologicals' HBV (Hepatitis B Virus) viral vector vaccines and adjuvanted proteins vaccine (GSK3528869A) in adult patients with chronic Hepatitis B infectioChronic hepatitis BMedDRA version: 20.1Level: PTClassification code 10008910Term: Chronic hepatitis BSystem Organ Class: 10021881 - Infections and infestationsEUCTR2017-001452-55-DEGlaxoSmithKline Biologicals158
进行中（未招募）
1 期
A study to evaluate the reactogenicity, safety, immunogenicity and efficacy of GlaxoSmithKline (GSK) Biologicals' HBV (Hepatitis B Virus) viral vector vaccines and adjuvanted proteins vaccine (GSK3528869A) in adult patients with chronic Hepatitis B infectioEUCTR2017-001452-55-BEGlaxoSmithKline Biologicals158
已完成
1 期
A first in human study to evaluate the safety and immune response to a vaccine for the treatment of a respiratory virus, when administered into the arm in healthy adult participants.Infection - Other infectious diseasesRespiratory - Other respiratory disorders / diseasesRespiratory Syncytial Virus InfectionACTRN12618000948291Advanced Vaccine Laboratories Pty Ltd60
招募中
1 期
A Phase I, Multicenter, Open-label, First-in-Human, Dose Escalation and Expansion Study of AZD9592 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid TumorsJPRN-jRCT2031230002Hibi Kazushige417