EUCTR2019-004483-22-IT进行中（未招募）1 期
A Phase 1b/2 Multicenter, Open-label, Dose-escalation and Dose expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of Trastuzumab Deruxtecan (TDXd) Monotherapy and Combinations in Adult Participants with HER2 Overexpressing Gastric Cancer (DESTINY-Gastric03) - DESTINY-Gastric03
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 220
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 participants must be at least 18 years of age
- •2 Disease Characteristics:
- •Locally advanced, unresectable, or metastatic disease
- •Pathologically documented adenocarcinoma of the stomach or GEJ with HER2 overexpression (IHC 3+ or ICH 2+/ISH+)
- •3. For Part 1, progression on or after at least one prior trastuzumab-containing regimen
- •For Part 2, previously untreated for unresectable or metastatic adenocarcinoma of the stomach or GEJ with HER2 overexpression.
- •4. Has measurable target disease assessed by the Investigator based on RECIST version 1.1
- •5. Has protocol- defined adequate organ function including cardiac, renal and hepatic function
- •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 age range 110
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 110
排除标准
- •1. History of active primary immunodeficiency, known HIV, active HBV or HCV infection, or active tuberculosis.
- •2. Uncontrolled intercurrent illness
- •3. History of non-infectious pneumonitis/ILD, current ILD, or where suspected ILD that cannot be ruled out by imaging at screening
- •4. Lung-specific intercurrent clinically significant severe illnesses
- •5. Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals
- •6. Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART).
研究者
相似试验
进行中（未招募）
1 期
A study of Trastuzumab Deruxtecan to assess its safety, tolerability, immune response, and inhibition of tumor activity when given alone or in combination with other agents in patients with HER2 Overexpressing Gastric CancerEUCTR2019-004483-22-DEAstraZeneca AB250
进行中（未招募）
1 期
A study of Trastuzumab Deruxtecan to assess its safety, tolerability, immune response, and inhibition of tumor activity when given alone or in combination with other agents in patients with HER2- expressing Gastric CancerPatients with Human Epidermal Growth Factor Receptor 2 (HER2)-expressing gastric, GEJ and esophageal cancerMedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2019-004483-22-NLAstraZeneca AB357
招募中
1 期
Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03)adenocarcinoma of the stomach, GEJ, or esophagusJPRN-jRCT2031200203Inoguchi Akihiro250
进行中（未招募）
1 期
A study of Trastuzumab Deruxtecan to assess its safety, tolerability, immune response, and inhibition of tumor activity when given alone or in combination with other agents in patients with HER2 expressing Gastric CancerPatients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing gastric, GEJ and esophageal cancerMedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2019-004483-22-PLAstraZeneca AB417
进行中（未招募）
1 期
A PHASE 1B/2 MULTI-CENTER STUDY TO FIND A WELL TOLERATED AND SAFE AND EFFECTIVE DOSE OF ACY-1215 (RICOLINOSTAT) IN COMBINATION WITH POMALIDOMIDE AND LOW-DOSE DEXAMETHASONE IN PATIENTS WITH MULTIPLE MYELOMA AFTER PROGRESSIVE OR RETURNING DISEASEThe treatment of multiple myeloma (MM) patients who have received at least 2 prior therapies, including a proteasome inhibitor and animmunomodulatory agent, and who are refractory to the most recent therapy.MedDRA version: 18.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864EUCTR2014-002338-29-ITAcetylon Pharmaceuticals, Inc.95