ACTRN12623001217695尚未招募1 期
An Open-Label Dose-Escalation Phase Ia Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Efficacy of IMD-101 Injectable in Participants with Advanced Malignant Solid Tumours.
Catalysis Therapeutics Pty Ltd0 个研究点目标入组 30 人开始时间: 2023年11月27日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
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
- •1.18- years of age and older (incl.), male or female.
- •2.Participants with histologically or cytologically confirmed advanced malignant solid tumours, ie melanoma, non-small cell lung cancer (NSCLC), renal cell cancer, mesothelioma, bladder cancer with at least one evaluable tumour lesion by RESPONSE EVALUATION CRITERIA IN SOLID TUMOURS (RECIST 1.1.), who failed standard of care treatment.
- •3.An Eastern Cooperative Oncology Group (ECOG) performance score of 0-1.
- •4.Survival expectancy > 3 months.
- •5.Adequate organ functions.
- •6.Eligible fertile participants (male and female) must agree to use a reliable contraceptive method (hormone, barrier method or abstinence) with their partners during the trial period and for at least 3 months after the last dose; female participants of childbearing age must have negative blood or urine pregnancy test within 7 days prior to enrollment. However, this requirement is not applicable to the females of non-child bearing potential who have been surgically sterilized (hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks before the screening visit) or postmenopausal females who have no menses for 12 months without an alternative medical cause and a follicle-stimulating hormone level consistent with postmenopausal status.
- •7.Participants must provide informed consent to this study and voluntarily sign the informed consent form prior to the start of the trial. They also need to be able to comply with the study visit schedule and required assessments.
排除标准
- •1.Receipt of anti-tumour treatments such as chemotherapy, radiotherapy, biotherapy, and endocrine therapy within 4 weeks prior to the first dose except the followings:
- •Nitrosoureas or mitomycin C within 6 weeks prior to the first dose of the study drug;
- •Oral fluorouracil and small-molecule targeted drugs within 2 weeks prior to the first dose of the study drug or within 5 half-lives of the drugs (whichever is longer);
- •2.Unlicensed investigational drugs or treatments within 4 weeks prior to the first dose of the study drug.
- •3.A participant who has previous treatment with IL-2 or IL-15 at investigator’s discretion.
- •4.Major organ surgery (excluding biopsy), significant trauma within 4 weeks prior to the first dose of the study drug, or the requirement to accept elective surgery during the trial.
- •5.Use of systemic corticosteroids (prednisone greater than 10 mg/day or an equivalent dose of similar drugs) or other immunosuppressive agents within 14 days prior to the first dose of the study drug except the following:
- •Use of topical, ocular, intra-articular, intranasal, and inhaled corticosteroids; short-term prophylactic use of corticosteroids (e.g., to prevent contrast agent allergy).
- •6.Adverse reactions of prior anti-tumour therapy that have not yet reverted to Common Terminology Criteria for Adverse Events (CTCAE 5.0) grade less than or equal to 1 (except for toxicities judged by the investigator to have no safety risk, e.g., alopecia, grade 2 peripheral neurotoxicity, hypothyroidism stabilised by hormone replacement therapy, etc.).
- •7.Past history of allogeneic hematopoietic stem cell transplantation or organ transplantation.
- •8.Past history of serious hypersensitivity to IL-2 and the excipient (sodium thiosulfate) of the study drug.
- •9.Past history of hypotension.
- •10.Central nervous system metastases, meningeal metastases with clinical symptoms, or other evidence indicating the participant has uncontrolled central nervous system metastases or meningeal metastases so that the participant is assessed to be ineligible by the investigator.
- •11.Active COVID19 infection based on positive PCR test at the time screening at investigator’s discretion.
研究者
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