JPRN-jRCT2031230234招募中1 期
FIRST-IN-HUMAN STUDY OF DS-1471A IN SUBJECTS WITH ADVANCED SOLID TUMORS
Akihiro Inoguchi0 个研究点目标入组 80 人开始时间: 2023年7月15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
- 80
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
- •The clinical sites will screen for the full inclusion criteria per protocol.
- •1. Sign and date the informed consent form (ICF)
- •2. Adults >=18 years at the time the ICF is signed
- •3. Has a histologically or cytologically documented, locally advanced, metastatic, or unresectable solid tumor that is refractory to or intolerable with standard treatment, or for which no standard treatment is available
- •4. Has at least 1 measurable lesion according to RECIST v1.1
- •5. Is willing and able to provide fresh tumor tissue biopsied at Baseline (mandatory) and on-treatment (mandatory if clinically allowed and not contraindicated)
- •6. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
- •7. Life expectancy >=3 months
- •8. Has a left ventricular ejection fraction (LVEF) >=50% within 28 days prior to Cycle 1 Day 1
- •9. Required baseline local laboratory data (within 7 days prior to Cycle 1 Day 1) as prespecified in the protocol
- •10. If the participant is a female of childbearing potential, she must have a negative serum pregnancy test within 7 days prior to study drug administration (Cycle 1 Day 1) and must be willing to use highly effective birth control upon enrollment, during the Treatment Period, and for 7 months following the last dose of study drug
- •11. If male, the participant must be surgically sterile or willing to use highly effective birth control upon enrollment, during the Treatment Period, and for 4 months following the last dose of study drug
- •12. Is willing and able to comply with scheduled visits, study drug administration plan, laboratory tests, other study procedures, and study restrictions
- •Patients with liver cirrhosis and/or hepatocellular carcinoma (HCC) may be eligible to participate if they meet additional protocol specified criteria
排除标准
- •1. Has an inadequate treatment washout period prior to start of study treatment (Cycle 1 Day1) as prespecified in the protocol
- •2. Has history of or current presence of untreated central nervous system (CNS) metastases
- •3. Has a history of leptomeningeal carcinomatosis
- •4. Has a history of (non-infectious) interstitial lung disease (ILD) other than radiation pneumonitis, currently has ILD, or when suspected ILD cannot be ruled out by imaging at screening
- •5. Has a history of severe pulmonary compromise or requirement of supplemental oxygen within 6 months before enrollment
- •6. Has any of the following within the past 6 months: cerebrovascular accident, transient ischemic attack, arterial thromboembolic event, or pulmonary embolism
- •7. Has uncontrolled or clinically significant cardiovascular disease
- •8. Is requiring chronic steroid treatment (>10 mg daily prednisone equivalents)
- •9. Has multiple primary malignancies, except adequately resected nonmelanoma skin cancer, curatively treated in situ disease, superficial cancer in the gastrointestinal tract curatively resected by endoscopic surgery, or any other solid tumors curatively treated with no evidence of recurrent disease for >=3 years
- •10. Has unresolved toxicities from previous anticancer treatment, defined as toxicities (other than alopecia) not yet resolved to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCICTCAE) Version (v)5.0, Grade <=1 or baseline
- •11. Exposure to another investigational medical product within 4 weeks prior to Cycle 1 Day 1 or current participation in other therapeutic investigational procedures
- •12. Has any known contraindication to treatment with, including hypersensitivity to the study drug substances or inactive ingredients in the study drug product
- •13. Has an active, known, or suspected autoimmune disease
- •14. Has evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection.
- •15. Has an active hepatitis or uncontrolled hepatitis B or C infection, except for HCC participants with hepatitis B infection that is controlled by antiviral therapy
- •16. Has human immunodeficiency virus (HIV) infection with exceptions per protocol for participants in Dose Expansion.
- •17. Has received a live, attenuated vaccine (messenger RNA [mRNA] and replication-deficient adenoviral vaccines are not considered live, attenuated vaccines) within 30 days prior to first exposure to study drug (Cycle 1 Day 1)
- •18. Female who is pregnant or breastfeeding
- •19. Has psychological, social, familial, or geographical factors that would prevent regular follow-up
- •20. Has prior or ongoing clinically relevant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the investigator's opinion, could affect the safety of the subject; alter the absorption, distribution, metabolism, or excretion of the study drug; or confound the assessment of study results
- •Patients with hepatocellular carcinoma (HCC) may be eligible to participate if they meet additional protocol specified criteria
研究者
相似试验
招募中
1 期
A Phase 1, first in human study of DS-1055a in subjects with relapsed or refractory locally advanced or metastatic solid tumorslocally advanced or metastatic head and neck cancer, gastric cancer, esophageal cancer, non-small cell lung cancer, or melanomaJPRN-jRCT2080225196DAIICHI SANKYO Co.,Ltd.40
已完成
1 期
Phase 1 study of DS-8201a in subjects with advanced solid malignant tumorsJPRN-jRCT2080222926DAIICHISANKYO Co.,Ltd., DAIICHI SANKYO, INC.278
终止
1 期
Phase I study of DS-2741a in Healthy Volunteers and Subjects with Atopic DermatitisHealthy volunteers and Japanese subjects with moderate to severe atopic dermatitis.JPRN-jRCT2080224983DAIICHI SANKYO Co., LTD.75
已完成
1 期
A Phase 1 Study of DS-1001b in Patients with IDH1 Mutated GliomasGliomaJPRN-jRCT2080223424DAIICHI SANKYO CO., LTD.18
已完成
1 期
First-in-human study of [18F]DiFAormal volunteersJPRN-UMIN000022066Hokkaido University Hospital8