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A Study of [177Lu]Lu-A9-0631 and [225Ac]Ac-A9-0642 With [68Ga]Ga-A9-6217 or [177Lu]Lu-A9-0631 Imaging in GRPR+ Solid Tumors

2026年9月2日 更新者：Alpha-9 Oncology USA Inc.

A Phase 1-1b Study to Evaluate the Safety, Efficacy, and Dosimetry of [177Lu]Lu-A9-0631, [225Ac]Ac-A9-0642, and [68Ga]Ga-A9-6217 in Participants With GRPR+ Tumors

This is a Phase 1-1b multicenter clinical study to evaluate the safety, efficacy, and dosimetry of [177Lu]Lu-A9-0631 and [225Ac]Ac-0642 in participants with Gastrin-Releasing Peptide Receptor (GRPR) expressing locally advanced, unresectable or metastatic solid tumors.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

This is a multicenter, open-label Phase 1-1b study of [177Lu]Lu-A9-0631 and [225Ac]Ac-A9-0642 in subjects with Gastrin-Releasing Peptide Receptor (GRPR) expressing locally advanced, unresectable or metastatic solid tumors.

The study consists of two parts (Phase 1 and 1b).

Phase 1 is the dose escalation portion of the study. The aim of the Phase 1 is to evaluate the safety and tolerability as well as the normal organ and tumor dosimetry of [177Lu]Lu-A9-0631 and [225Ac]Ac-A9-0642, and to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D).

Phase 1b will be the dose expansion portion of the study. The aim of the Phase 1b will be to further evaluate the safety, efficacy, and normal organ and tumor dosimetry of [177 Lu]Lu-A9-0631 and [225Ac]Ac-A9-0642 administered at the RP2D in subjects with (1) Locally advanced, unresectable, or metastatic HR+/HER2- breast cancer; (2) Locally advanced, unresectable, or metastatic prostate cancer; (3) Locally advanced, unresectable, or metastatic CRC; and (4) Other locally advanced, unresectable, or metastatic GRPR-positive solid tumors.

研究类型

介入性

注册 (估计的)

115

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 澳大利亚
    • Victoria
      • Melbourne N.、Victoria、澳大利亚、3051
        • 招聘中
        • Melbourne Theranostic Innovation Center
        • 接触：
        • 首席研究员：
          • Prof. Rod Hicks
    • Western Australia
      • Murdoch、Western Australia、澳大利亚、6150
        • 尚未招聘
        • GenesisCare Murdoch
        • 接触：
        • 首席研究员：
          • Prof. Joe Cardaci

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Participant has provided written informed consent prior to any study-specific procedure.
  • Age ≥ 18 years old.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  • Have measurable target lesion per RECIST v1.1.
  • Progression from, intolerant to, or ineligible for (due to unavailability or contraindication) local standard of care therapies and have one of the following locally advanced or metastatic tumor types: prostate cancer; HR+/HER2- breast cancer; colorectal cancer; and GRPR-positive solid tumors.
  • Have GRPR-expressing disease as confirmed by PET / CT or SPECT imaging.
  • Adequate organ function within 14 days of first administration of investigational therapeutic product.
  • At least 4 weeks from prior major surgery.

Exclusion Criteria:

  • Received anticancer treatment including but not limited to chemotherapy, antibody therapy, immunotherapy, gene therapy, vaccine therapy, angiogenesis inhibitors, or experimental drugs ≤ 14 days prior (≤ 28 days prior in case of checkpoint inhibitor therapy and other antibody therapies) or 5 half-lives, (t1/2) whichever is shorter, to the administration of therapeutic investigational product.
  • History of uncontrolled allergic reactions and/or known or expected hypersensitivity to a peptide-based imaging or therapeutic agent or any excipient present in either of the therapeutic investigational products.
  • Major surgery within 4 weeks of planned first dose of the therapeutic investigational product.
  • Prior external beam radiation therapy to more than 25% of the bone marrow.
  • Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
  • Any active infection.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：非随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：第一阶段剂量递增
诊断测试：[68Ga]Ga-A9-6217
Administered IV
诊断测试：Low dose [177Lu]Lu-A9-0631
Administered IV
药品：[177Lu]Lu-A9-0631
Administered IV
药品：[225Ac]Ac-A9-0642
Administered IV
实验性的：Phase 1B Dose Expansion
诊断测试：[68Ga]Ga-A9-6217
Administered IV
诊断测试：Low dose [177Lu]Lu-A9-0631
Administered IV
药品：[177Lu]Lu-A9-0631
Administered IV
药品：[225Ac]Ac-A9-0642
Administered IV

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Phase 1-1b: Incidence of Adverse Events by Frequency, Duration, and Severity
大体时间：From the first dose of study drug up to the End of Treatment (30 days after the last dose)
An AE is defined as any untoward medical occurrence in a participant administered study drug, which does not necessarily have to have a causal relationship with the study drug. The number of patients experiencing an AE in Part 1 will be reported.
From the first dose of study drug up to the End of Treatment (30 days after the last dose)
Phase 1: Number of Patients with Dose-Limiting Toxicities (DLTs).
大体时间：Up to 28 days following first study treatment
DLTs is defined as any predefined AE occurring during the DLT observation period.
Up to 28 days following first study treatment
Phase 1: Maximum tolerated dose (MTD)
大体时间：Up to 28 days following first study treatment
Incidence of dose-limiting toxicity (DLT) per dose level of [177Lu]Lu-A9-0631 and/or [225Ac]Ac-A9-0642.
Up to 28 days following first study treatment

次要结果测量

结果测量
措施说明
大体时间
Phase 1-1b: Absorbed dose estimates (Gy) in normal organs for [177Lu]Lu-A9-0631 and/or [225Ac]Ac-A9-0642
大体时间：Up to 7 days after each injection for up to 6 cycles (each cycle is 28 days)
Up to 7 days after each injection for up to 6 cycles (each cycle is 28 days)
Phase 1-1b: Objective Response Rate (ORR)
大体时间：Every 8 ± 1 weeks until radiographic disease progression or up to 12 months after the last dose of [177Lu]Lu-A9-0631 and/or [225Ac]Ac-A9-0642
Objective response rate is defined as the percentage of patients who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), as determined by the investigator based on RECIST 1.1, by dose level.
Every 8 ± 1 weeks until radiographic disease progression or up to 12 months after the last dose of [177Lu]Lu-A9-0631 and/or [225Ac]Ac-A9-0642

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Alpha-9 Oncology USA Inc.

调查人员

  • 研究主任：Stephen Hull, MD、Alpha 9 Oncology

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年7月1日

初级完成 (估计的)

2028年12月1日

研究完成 (估计的)

2029年12月1日

研究注册日期

首次提交

2026年6月9日

首先提交符合 QC 标准的

2026年6月16日

首次发布 (实际的)

2026年6月22日

研究记录更新

最后更新发布 (实际的)

2026年9月4日

上次提交的符合 QC 标准的更新

2026年9月2日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • A9-0600-01

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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