JPRN-jRCT2031230410招募中1 期
A phase I, open-label, multi-center, study of KFA115 as a single agent and in combination with tislelizumab in patients with select advanced cancers
Yonemura Masataka0 个研究点目标入组 10 人开始时间: 2023年10月17日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Non-small cell lung cancer with historic PD-L1 >= 1%, as determined locally using a clinically accepted assay. Patients must have experienced benefit from previous anti-PD(L)1-containing therapy for at least 4 months based on investigator-assessed disease stability or response prior to developing documented disease progression.
- •-Renal cell carcinoma, clear cell histology, previously treated with anti-PD(L)1-containing therapy and a VEGF targeted therapy as monotherapy or in combination. Patients should have documented disease progression following anti-PD(L)1-containing therapy.
- •-Cutaneous melanoma, previously treated with anti-PD(L)1-containing therapy. Patients should have documented disease progression following anti-PD(L)1-containing therapy.
- •-Ovarian cancer, high-grade serous histology, naive to anti-PD(L)1 therapy, no more than 3 prior lines of systemic therapy for recurrent/metastatic disease.
- •-Nasopharyngeal carcinoma, non-keratinizing locally advanced recurrent or metastatic, naive to anti-PD(L)1 therapy.
- •-Locally advanced unresectable or metastatic anal cancer (squamous), thymic carcinoma, MSI-H CRC, esophagogastric cancer, mesothelioma, and HNSCC, all naive to anti-PD(L)1 therapy.
- •-Patients must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating institution guidelines. Patient must be willing to undergo a new tumor biopsy at screening, and during therapy on the study, if medically feasible. Exceptions may be considered after documented discussion with Novartis. Patients with archival tumor tissue obtained =< 6 months prior to study treatment initiation do not need to undergo a new tumor biopsy at screening, if the patient has not received any anti cancer therapy since the biopsy was taken, and if adequate tissue is available.
- •-Patients must have body weight > 36 kg.
排除标准
- •-Impaired cardiac function or clinically significant cardiac disease.
- •-Use of agents known to prolong the QT interval unless they can be permanently discontinued for the duration of study.
- •-History of severe hypersensitivity reactions to any ingredient of study drug(s) and other mAbs and/or their excipients.
- •-Active, known or suspected autoimmune disease. Patients with vitiligo, type I diabetes, residual hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment or conditions not expected to recur may be considered. Patients previously exposed to anti-PD-1/PD-L1 treatment who are adequately treated for skin rash or with replacement therapy for endocrinopathies should not be excluded.
- •-Any evidence of interstitial lung disease (ILD) or pneumonitis, or a prior history of ILD or non-infectious pneumonitis requiring high dose glucocorticoids.
- •-Patients who discontinued prior anti-PD-(L)1 therapy due to an anti PD-(L)1-related toxicity (applicable to the KFA115 in combination with tislelizumab treatment arms).
- •-Patients with symptomatic peripheral neuropathy limiting instrumental activities of daily living.
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