NL-OMON49457尚未招募不适用
An open label Phase I Positron Emission Tomography Imaging study to investigate the bio-distribution and tumor uptake of [89Zr]Zr-BI 905677 in patients with advanced tumors harbouring an RNF43 mutation or R-Spondin Fusion - A study how BI 905677 acts in tumors of patients with cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Histologically or cytologically confirmed advanced, unresectable and/or
- •metastatic solid tumours with a documented RNF43 mutation or R-Spondin fusion
- •2.Failure to conventional treatment and no therapy of proven efficacy existing
- •or ineligibility for established Treatment options
- •3. Eastern Cooperative Oncology Group (ECOG) score: 0 to 1
- •4. At least one Positron emmission tomography (PET)-imageable, evaluable tumor
- •lesion (>=20 mm) according to Revised Response Evaluation Criteria in Solid
- •Tumors (RECIST) Version 1.1
- •5. At least one biopsiable tumor lesion
- •6. Life expectancy of at least 12 weeks after the start of the treatment
- •according to the Investigator*s judgement
排除标准
- •1. Major surgery performed within 4 weeks prior to first Trial treatment or
- •planned within 6 months after Screening
- •2. Previous or concomitant malignancies other than the one treated in this
- •trial within the last 2 years
- •3. Osteoporosis >= Common Terminology Criteria for Adverse Events (CTCAE) Grade
- •2 or osteoporotic compression fracture within 12 months prior to informed
- •4. Treatment with an anti-cancer therapy or investigational drug within 28 days
- •or 5 half-lives of the first treatment with the study medication
- •5. Presence or history of uncontrolled or symptomatic brain or subdural
- •6. History of human immunodeficiency virus (HIV) infection or an active
- •hepatitis B or C infection
- •7. History of severe hypersensitivity reactions to monoclonal antibodies or
- •allergy to kanamycin or similar class drugs
- •8. Women who are pregnant, nursing, or who plan to become pregnant or nursing
- •during the trial or within 6 months after the last dose of study treatment
研究者
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