临床试验/NCT06234605

NCT06234605招募中1 期

A Phase 1b, Open-Label, Safety, Tolerability, and Efficacy Study of HC- 7366 in Combination With Belzutifan (WELIREG™) in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma

HiberCell, Inc.20 个研究点分布在 1 个国家目标入组 80 人开始时间: 2024年4月29日最近更新: 2026年1月15日

适应症

干预措施

试验速览

阶段: 1 期
状态: 招募中
发起方: HiberCell, Inc.
入组人数: 80
试验地点: 20
主要终点: Determination of MTD and RP2D (combination cohorts only)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验相关资讯

研究概览

简要总结

This is a Phase 1b, open-label, multicenter, safety, tolerability and efficacy study of HC-7366 in combination with belzutifan (WELIREG™). This is a multipart study that consists of a HC-7366 monotherapy cohort, a combination dose escalation, and a combination dose expansion. Approximately 80 patients will be enrolled in this study (up to 20 patients will be enrolled into the HC-7366 monotherapy cohort, up to 30 patients into the combination dose escalation, and up to 30 patients into the combination dose expansion). The primary purpose of this study is to determine the maximum tolerated dose of HC-7366 in combination with belzutifan in patients with locally advanced (inoperable) or metastatic RCC with predominantly clear cell histology, irrespective of VHL gene mutation status.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Has diagnosis of locally advanced (inoperable) or metastatic RCC with a predominant clear cell component
•Be age 18 years or older (male or female) at the time of consent

排除标准

未提供

研究组 & 干预措施

Monotherapy

Experimental

Participants will receive HC-7366 monotherapy [dose to be determined] daily

干预措施: HC-7366 (Drug)

Combination

Experimental

Participants will receive HC-7366 monotherapy [dose to be determined] in combination with belzutifan [120 mg] daily

干预措施: HC-7366 (Drug)

Combination

Experimental

Participants will receive HC-7366 monotherapy [dose to be determined] in combination with belzutifan [120 mg] daily

干预措施: Belzutifan (Drug)

结局指标

主要结局

Determination of MTD and RP2D (combination cohorts only)

时间窗: 30 months

To identify the maximum tolerated dose (MTD) and/ or recommended Phase 2 dose (RP2D), and evaluate the safety, tolerability and dose-limiting toxicities (DLTs) of HC-7366 in combination with belzutifan in patients with locally advanced (inoperable) or metastatic RCC with predominantly clear cell histology irrespective of VHL gene mutation status

次要结局

未报告次要终点

研究者

发起方

HiberCell, Inc.

申办方类型

Industry

责任方

Sponsor

研究点 (20)

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相关资讯

HiberCell's HC-7366 Shows Promise in Late-Line Renal Cell Carcinoma with 37% Response Rate in Phase 1b Trial- HiberCell's Phase 1b trial of HC-7366 combined with belzutifan demonstrated a 37% best overall response rate in patients with advanced clear cell renal cell carcinoma who had failed prior checkpoint inhibitor and VEGF-TKI therapy. - The combination therapy showed a manageable safety profile with mostly Grade 1-2 adverse events and achieved an 84-89% disease control rate across dose levels in 69 enrolled patients. - Translational analyses confirmed HC-7366 pathway engagement and revealed favorable changes countering ccRCC biology, including sustained HIF-2 target inhibition and modulation of angiogenic pathways. - The encouraging preliminary results support continued evaluation in the fully enrolled Expansion 2 cohort, with updated results expected in the second half of 2026.5 months ago FDA Grants Fast Track Designation to HC-7366 for Relapsed/Refractory AML- The FDA has granted Fast Track designation to HC-7366 for treating adult patients with relapsed or refractory acute myeloid leukemia (AML). - HC-7366 is a first-in-class, selective, and potent small-molecule GCN2 kinase modulator currently under investigation for various solid and liquid tumors. - A phase 1b trial (NCT06285890) is evaluating HC-7366 with venetoclax and azacitidine for relapsed/refractory AML or myelodysplastic syndrome (MDS) AML. - The Fast Track designation aims to expedite the development and review of HC-7366, addressing a significant unmet need in relapsed/refractory AML.last year HiberCell's HC-7366 Receives FDA Fast Track Designation for Relapsed/Refractory AML• HiberCell's HC-7366, a GCN2-activator, has been granted Fast Track designation by the FDA for treating relapsed or refractory acute myeloid leukemia (R/R AML). • The FDA's decision highlights HC-7366's potential to address the significant unmet need in R/R AML, based on robust preclinical data. • HC-7366 is currently in Phase 1b clinical trials, evaluating its safety, tolerability, and preliminary efficacy in R/R AML or MDS AML patients. • This Fast Track designation may expedite the development of HC-7366, allowing HiberCell to work closely with the FDA during the process.last year