JPRN-jRCT2031220703尚未招募1 期
A Phase 1, Open-label, Dose-escalation and Dose-expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of D3S-001 Monotherapy in Subjects with Advanced Solid Tumors with a KRAS p.G12C Mutation - D3S-001-100
Kanemitsu Jun0 个研究点目标入组 10 人开始时间: 2023年3月14日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
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
- •Subject must have a histologically or cytologically confirmed metastatic or locally advanced solid tumor which is progressing.
- •- Subject must have documented KRAS p.G12C mutation identified within the last 5 years by a local test on tumor tissue or blood.
- •- Subject must have measurable disease per RECIST v1.1.
- •- Subject must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- •- Subject must have adequate organ and marrow function within the screening period.
排除标准
- •- Subject has any prior treatment with other treatments without adequate washout periods as defined in the protocol.
- •- Subject has uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, uncontrolled or significant cardiovascular disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirements, substantially increase risk of incurring AEs, or compromise the ability of the subject to give written informed consent.
- •- Subject has unresolved treatment-related toxicities from previous anticancer therapy of NCI CTCAE Grade >=2 (with exception of vitiligo or alopecia).
- •- Subject has active gastrointestinal disease or other that could interfere significantly with the absorption, distribution, metabolism, or excretion of oral therapy.
- •- Concurrent participation in any clinical research study involving treatment with any investigational drug, radiotherapy, or surgery, except for the nontreatment phases of these studies (e.g., follow-up phase).
研究者
相似试验
招募中
不适用
A Phase 1, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of MEDI5752 in Subjects with Advanced Solid TumorsAdvanced solid tumors: subjects withclear-cell renal cell carcinoma (referred to as RCC expansion cohort) and subjects with first-lineStage IIIB or IV nonsquamous non-small cell lung cancer (NSCLCreferred to as NSCLC expansion cohort). = renal cell carcinoma and nonsquamous non-small cell lung cancer10027656NL-OMON54211MedImmune, LLC, a wholly owned subsidiary of AstraZeneca PLC10
进行中（未招募）
1 期
A study to test if different doses of D3S-001 used on its own are safe and tolerable in people with advanced solid tumors with KRAS p.G12C modificatioCTIS2023-508517-16-00D3 Bio (Wuxi) Co. Ltd.165
进行中（未招募）
1 期
A Study of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants with Advanced or Metastatic Non-small Cell Lung CancerAdvanced Non-small Cell Lung Cancer, Metastatic Non-small Cell Lung Cancer, stage III unresectable Non-small Cell Lung Cancer (Protocol Parts A-B), stage IV Non-small Cell Lung Cancer (Protocol Parts A-D).MedDRA version: 20.1Level: LLTClassification code 10080083Term: Advanced lung cancerSystem Organ Class: 100000004864EUCTR2021-000857-23-DKAstraZeneca AB192
招募中
2 期
A Phase I/II, Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of rilvegostomig (AZD2936) Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants with Advanced or Metastatic Non-small Cell Lung Cancer (ARTEMIDE-01)LungcancerNon-small cell lungcarcinoma10038666NL-OMON54261Astra Zeneca18
进行中（未招募）
1 期
A Study of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants with Advanced or Metastatic Non-small Cell Lung CancerAdvanced Non-small Cell Lung Cancer, Metastatic Non-small Cell Lung Cancer, stage III unresectable Non-small Cell Lung Cancer, stage IV Non-small Cell Lung Cancer.MedDRA version: 20.1Level: LLTClassification code 10080083Term: Advanced lung cancerSystem Organ Class: 100000004864EUCTR2021-000857-23-NLAstraZeneca AB192