2024-510987-22-00招募中2 期
A Phase 2 Pilot Study to Evaluate the Safety and the Anti-Tumour Activity of the Myc Inhibitor OMO-103 Administered Intravenously in Patients with Advanced High-Grade Osteosarcoma
Vall D Hebron Institute Of Oncology1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年9月23日最近更新:
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Progression-free survival rate at 16 weeks (16-week PFS) according to RECIST V1.1 by Investigator assessment.
研究概览
简要总结
To assess the preliminary anti-tumour activity of OMO-103 monotherapy in patients with high-grade osteosarcoma
入排标准
- 年龄范围
- 0 years 至 65+ years（0-17 Years, 65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥12 years at time of informed consent
- •Histologically proven, advanced high-grade osteosarcoma not suitable for local treatments with curative intent
- •Confirmed disease progression by radiological report to at least one line of standard chemotherapy containing cisplatin and anthracycline, and no more than 2 previous lines.
- •Measurable disease as per RECIST v1.1 criteria and documented by CT/MRI (Appendix 1 – RECIST Response Criteria).
- •Provision of a newly obtained tumour biopsy (either from the primary tumour or from metastases) during screening and on-treatment from all patients >16 years of age.
- •Documented progression on or following the last line of therapy
- •If not postmenopausal or surgically sterile, female patients and female sexual partners of male patients must be willing to use at least one highly effective method of birth control (hormonal contraception, IUD, abstinence, condom) for at least a menstrual cycle before and for 3 months after last study drug administration.
排除标准
- •Treatment with systemic anti-cancer therapy within three weeks prior to study drug administration for chemotherapy and 5 half-lives for targeted therapies.
- •Radiation therapy within four weeks prior to study entry. Localised palliative radiotherapy to non-target lesions is allowed.
- •Low-grade osteosarcoma, parosteal, or periosteal osteosarcoma.
- •Prior history of other malignancies other than osteosarcoma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) unless the patient has been free of the disease for at least 2 years.
- •Non-malignant systemic disease including cerebrovascular accident, unstable angina pectoris, unstable atrial fibrillation, unstable cardiac arrhythmia, myocardial infarction in the last six months, New York Heart Association (NYHA) Class III or IV heart failure
- •Patients with active uncontrolled infection or known to be serologically positive for human immunodeficiency virus (HIV), hepatitis B (except after vaccination) or hepatitis C infection. Investigators may test as per their discretion.
- •Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study.
- •Patients with symptomatic or unstable central nervous system primary tumour or metastases and/or sarcomatous meningitis
- •Patients with allergies or hypersensitivity reactions to the active substance or to any of its excipients
结局指标
主要结局
Progression-free survival rate at 16 weeks (16-week PFS) according to RECIST V1.1 by Investigator assessment.
Progression-free survival rate at 16 weeks (16-week PFS) according to RECIST V1.1 by Investigator assessment.
次要结局
- • Objective Response Rate (ORR) • Disease Control Rate (DCR) • Time to Progression (TTP) • Time to Response (TTR) • Duration of Response (DOR) • Overall survival (OS)
- • Incidence and severity of adverse events (AEs), graded by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.• Safety will be assessed through routine monitoring of adverse events, evaluation of laboratory parameters, vital signs, physical examination and ECGs.
- PK parameters of OMO-103: AUC; Cmax; tmax; t1/2.
- • Health-related quality of life (HRQoL) measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire – Core 30 items (EORTC-C30) for adult patients, and by the Pediatric Quality of Life Inventory (PedsQL) for patients between 12 and 17.
- • Q-TWiST approach [time experiencing toxicity (grade 3/4 AEs) before progression, time without toxicity or symptoms of progression, and time after progression]
研究者
Chief Medical Officer
Scientific
Vall D Hebron Institute Of Oncology
研究点 (1)
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