2024-517419-62-00招募中2 期
(22752) A Phase 2 open-label basket study to evaluate the efficacy and safety of orally administered reversible tyrosine kinase inhibitor BAY 2927088 in participants with metastatic or unresectable solid tumors with HER2-activating mutations
Bayer Consumer Care AG, Bayer AG18 个研究点 分布在 4 个国家目标入组 37 人开始时间: 2025年2月13日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 37
- 试验地点
- 18
- 主要终点
- Objective response rate (ORR) per RECIST 1.1 as assessed by blinded independent central review (BICR)
研究概览
简要总结
To evaluate the efficacy of sevabertinib in objective response rate (ORR) as assessed by blinded independent central review (BICR)
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Treatment Period
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Documented histologically or cytologically confirmed locally advanced, unresectable or metastatic solid tumor cancer (colorectal carcinoma; biliary tract cancer; bladder and urothelial tract cancer; cervical cancer; endometrial cancer; breast cancer; other solid tumor cancer, excluding NSCLC)
- •Participant must be ≥18 years of age or over the legal age of consent
- •Patients who have received prior standard therapy appropriate for their tumor type and stage of disease, or who have no satisfactory alternative treatments
- •Documented activating HER2 mutation
- •At least one measurable lesion that would qualify as a target lesion by RECIST 1.1 criteria
排除标准
- •Primary diagnosis of non-small cell lung cancer(NSCLC)
- •Prior treatment with a HER2 tyrosine kinase inhibitor (TKI)
- •Active brain metastases
- •Uncontrolled, severe, intercurrent illness
结局指标
主要结局
Objective response rate (ORR) per RECIST 1.1 as assessed by blinded independent central review (BICR)
Objective response rate (ORR) per RECIST 1.1 as assessed by blinded independent central review (BICR)
次要结局
- Duration of response (DOR) per RECIST 1.1 as assessed by BICR
- Time to response (TTR) per RECIST 1.1 as assessed by BICR
- ORR per RECIST 1.1 as assessed by the investigator
- Disease control rate (DCR) per RECIST 1.1 as assessed by BICR
- DCR ≥12 weeks per RECIST 1.1 as assessed by BICR
- Progression-free survival (PFS) per RECIST 1.1 as assessed by BICR
- Disease control rate (DCR) per RECIST 1.1 as assessed by the investigator
- DCR ≥12 weeks per RECIST 1.1 as assessed by the investigator
- Progression-free survival (PFS) per RECIST 1.1 as assessed by the investigator
- DOR per RECIST 1.1 as assessed by the investigator
- TTR per RECIST 1.1 as assessed by the investigator
- Overall survival (OS)
- Number of participants with treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs) per CTCAE v 5.0, categorized by severity. Number of participants who discontinue study treatment due to an AE
- Time to deterioration in EORTC QLQ-C30 physical functioning domain score
- Change from baseline in EORTC QLQ-C30 physical functioning domain score
- Change from baseline in EORTC QLQ-C30 global health status/quality of life (QoL)
研究者
Bayer Clinical Trials Contact
Scientific
Bayer AG
研究点 (18)
Loading locations...
相似试验
招募中
2 期
Taletrectinib in ROS1 Positive Lung Cancer Phase 2 Global StudyNon-small Cell Lung Cancer2024-516604-41-00Anheart Therapeutics Inc.98
招募中
3 期
52 weeks double-blind, double-dummy, randomized placebo-controlled trial to evaluate safety, efficacy and tolerability of remibrutinib in comparison to placebo with omalizumab as active control in adult patients with CSU and inadequate response to H1-antihistamine and an open-label 52-week optional extension to assess long-term efficacy, safety and tolerability of remibrutinib 25 mg b.i.d.2022-502161-19-00Novartis Pharma AG214
尚未招募
3 期
Open-Label Extension Study of MHB018A in Subjects With Thyroid Eye DiseaseNCT07262476Minghui Pharmaceutical (Hangzhou) Ltd258
尚未招募
2 期
A Phase II Clinical Study of Zanubrutinib Combined With Four Cycles of CD20 Monoclonal Antibody and Reduced-Dose Bendamustine in the Treatment of Untreated Waldenström MacroglobulinemiaNCT07259122Institute of Hematology & Blood Diseases Hospital, China43
招募中
2 期
CHIP-AML22/Quizartinib sub-study: study of the safety and efficacy of quizartinib in children and adolescents with FLT3-ITD positive AML with normal NPM1.2023-505000-27-01Prinses Maxima Centrum voor Kinderoncologie B.V.60