A study to find a suitable dose of ASP5834 in adults with solid tumors

预期结果

In this study, ASP5834 is being given to humans for the first time. 本研究为开放性研究。This means that people in this study and clinic staff will know that they will receive ASP5834 by itself or ASP5834 with panitumumab.

本研究分为 2 个部分。

Part 1 is called Dose Escalation. Different small groups of people will receive lower to higher doses of either: ASP5834 by itself or ASP5834 together with panitumumab. Only people who have colorectal cancer will receive ASP5834 together with panitumumab. People with any type of solid tumor will receive ASP5834 by itself. For each dose, all medical problems will be recorded. A medical expert panel will check the results and decide if the next group can receive a higher dose of ASP5834. The panel will do this until the planned maximum number of people are treated or until suitable doses have been selected for Part 2.

Part 2 is called Dose Expansion. Other different small groups of people will receive ASP5834 or ASP5834 together with panitumumab. They will receive the most suitable doses worked out from Part 1.

In both parts of the study, the study treatments ASP5834 and panitumumab will be given through a vein. 这一过程称为输液。每个治疗周期持续 21 或 28 天。People will continue study treatment until:

• they have medical problems from the study treatment they can’t tolerate;
• 他们的癌症病情恶化；
• 他们开始接受其他癌症治疗；
• or they ask to stop study treatment.

People will visit the clinic on certain days during their study treatment, with extra visits during the first 2 cycles of study treatment. The study doctors will check for any medical problems from ASP5834. Also, people in the study will have a health check. 在一些就诊中，他们还将接受扫描，以检查癌症是否有任何变化。Tumor samples will be taken at certain visits during study treatment with the option of a tumor sample being taken if people’s cancer gets worse or the cancer comes back.

受试者将在停止治疗后不久前往诊所接受健康检查。After this, people will have health checks every couple of months to check the condition of their cancer. The number of visits and checks done will depend on the health of each person and whether they completed their study treatment or not. It is expected that people will be in this study for about 1 year.