ACTRN12623000108617招募中1 期
A modular, multi-part, multi-arm, open-label, Phase I/II Study to evaluate the safety and tolerability of GRWD5769 in patients with solid malignancies - Module 1.
Grey Wolf Therapeutics Pty Ltd0 个研究点目标入组 60 人开始时间: 2023年1月31日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Module 1A, 1B & 1C
- •1. Participant has cytologically or histologically confirmed locally advanced or metastatic solid malignancy for which no further standard of care (SoC) therapy is available (or no SoC therapy exists), or who have been offered and declined SoC therapy, or are intolerant of SoC therapy.
- •2. Participant has measurable disease per RECIST 1.1/iRECIST.
- •Module 1B specific
- •3. Participant has at least one tumour lesion amenable to serial biopsies and is willing to
- •provide consent for biopsies and has measurable disease per RECIST 1.1/iRECIST,
- •excluding the lesion(s) identified for biopsy.
- •Module 1D specific
- •Additional selection criteria for Module 1 Part D will be described in a
- •future protocol amendment.
排除标准
- •All study Modules 1:
- •1. Prior therapy with an ERAP1 inhibitor, within any timeframe prior to the first dose of study drug.
- •2. Any other malignancy not meeting inclusion criterion 1 (Module 1 Parts A, B, and C), which has been active or treated within the past 3 years, with the exception of cervical intraepithelial neoplasia and non-melanoma skin cancer.
- •3. Any unresolved toxicity (except alopecia) from prior therapy of greater than or equal to CTCAE Grade 1 prior to the day of the first dose of IMP. Participants with Grade 2 toxicity that is not clinically significant (e.g., alopecia, vitiligo), or that is deemed stable or irreversible (e.g., peripheral neuropathy) can be enrolled.
- •4. Active or documented history of autoimmune disease (within 2 years) requiring systemic immunosuppressive therapy, or participant is immunocompromised for any other reason (as determined by the Investigator).
研究者
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