CTIS2024-510722-10-00招募中1 期
First-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate safety of GEN1047 in subjects with malignant solid tumors - GCT1047-01
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Genmab A/S
- 入组人数
- 333
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 65+（—）
- 性别
- All
入选标准
- •Dose Escalation part: Subject must have histologically or cytologically confirmed solid tumor(s) in any of the following selected indications for which there is no further available standard therapy likely to confer clinical benefit (or subject is not a candidate or has previously refused such earlier available therapy), and for whom, in the opinion of the investigator, experimental therapy with GEN1047 may be beneficial (breast cancer, endometrial cancer, ovarian cancer, squamous non-small-cell lung cancer [NSCLC-SCC])., Dose Expansion part: Subject must have advanced (unresectable) or metastatic, histologically confirmed diagnosis (breast cancer, endometrial cancer, ovarian cancer, squamous non-small cell lung cancer [NSCLC-SCC])., Dose Expansion part: Must be a female and at least 18 years of age (or the legal age of consent in the jurisdiction in which the trial is taking place) at the time of consent., Dose Expansion part: Must have at least 1 measurable lesion per RECIST v1.1 as assessed by local investigator., Dose Expansion part: Must have an ECOG- PS score of 0 to 1 at Screening and on Cycle 1 Day 1 (C1D1) pretreatment., Dose Expansion part: Should provide a tumor tissue sample during the Screening period and prior to C1D1., Dose Expansion part: Provide all tumor-assessing pre-trial CT scans since failure of last prior therapy., Dose Escalation part: Subjects with ovarian cancer must have documented progressive disease (PD) on or after last prior treatment and within 60 days of Screening., Dose Escalation part: Must be at least 18 years of age (or the legal age of consent in the jurisdiction in which the trial is taking place) on the day of signing informed consent., Dose Escalation part: Must have either recurrence after, or progression on or lack of response to available relevant standard of care (SoC) anticancer therapies; or are deemed intolerant to or ineligible for, standard curative therapy in the recurrent setting., Dose Escalation part: Must have at least 1 measurable lesion per RECIST v1.1. The measurable lesion(s) must be outside the field of radiation therapy (RT) if there was prior treatment with RT., Dose Escalation part: Must have an Eastern Cooperative Oncology Group performance status (ECOGPS) score of 0 to 1 at Screening and on C1D1 pretreatment., Dose Escalation part: Should provide a tumor tissue sample during the Screening period and prior to C1D1., Dose Escalation part: Provide all tumor-assessing pre-trial CT scans since failure of last prior therapy., Dose Expansion part: Subjects must have documented PD according to RECIST v1.1 on or after last prior treatment with latest scan performed a maximum of 28 days prior to the first dose.
排除标准
- •Significant cardiovascular impairment within 6 months of the first dose of trial drug, Subject with new or progressive brain metastases or spinal cord compression., Subject has a history of bowel obstruction related to underlying disease., Subject has been exposed to any prior therapy with a compound targeting CD3 and/or B7H4 or cell based therapies., Current pneumonitis (any grade) including any radiological change of ongoing pneumonitis at baseline or history of non-infectious drug-, immune-, or radiation-related pneumonitis that required steroid.
研究者
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