JPRN-jRCT2031220721招募中1 期
A Phase 1, Open-Label, Dose-Escalation Study of RM-1995 Photoimmunotherapy Alone or in Combination with pembrolizumab in Patients with Advanced or Recurrent Solid Tumor with Liver Metastasis
Okuda Daisuke0 个研究点目标入组 34 人开始时间: 2023年3月21日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 34
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
- •Provide written informed consent.
- •- Male or female >= 18 years of age at the time of informed consent.
- •- Have advanced or recurrent solid tumor with a hepatic metastasis diagnosed as histologically malignant.
- •- Unresponsive or intolerant to standard therapy for each type of cancer, as evaluated by the Investigators, or unwilling to be treated with the relevant standard treatments for some reason.
- •- Have at least 1 hepatic lesion which can be illuminated using a needle catheter or cylindrical diffuser.
- •- Before study treatment initiation (C1D1) and on 21 days after the first administration of RM-1995, tumor samples can be collected from a hepatic lesion with planned illumination treatment as well as a hepatic lesion or extrahepatic lesion (including primary lesion) with no illumination treatment planned. Consented to provide enough fresh and FFPE tumor tissue samples for exploratory studies of pharmacodynamic biomarkers.
- •- Eastern Cooperative Oncology Group (ECOG) performance status is 0 to 1 at enrollment.
- •- Have sufficient organ function (all laboratory examination at screening should be done within 14 days before enrollment.
- •- Women of childbearing potential (WOCBP)who are not pregnant or breastfeeding. Agree to use one of the two highly effective contraceptive methods or refrain from sexual intercourse, as well as not to provide any eggs (ova and oocytes) for reproductive purposes during the study period and for at least 120 days after final administration of the study drug.
- •- Male patients who are infertile, agree to use appropriate contraceptive methods, or refrain from sexual intercourse. Agree not to provide sperms for reproductive purposes from the first study treatment to at least 120 days after final administration of the study drug.
排除标准
- •- Treated with anti-cancer treatment for a specific period, as described below.
- •Patients who are treated with chemotherapy or hormone therapy within 2 weeks prior to study treatment initiation or 5 times the half-life of the drug
- •Patients who are treated with radiation therapy or other local therapy within 2 weeks prior to study treatment initiation.
- •Patients who are treated with immunotherapy within 6 weeks prior to study treatment initiation or 5 times the half-life of the drug.
- •- Patients who have not recovered (i.e., not Grade =< 1 at enrollment) from anti-cancer treatment-related toxicity.
- •- Patients with a history of discontinuation of immunotherapy due to Grade >= 3 toxicity evaluated by the Investigator as related to the mechanism of action of the study drug (and pembrolizumab, in cases of combination therapy).
- •- Patients with a history or complication of interstitial lung disease that requires systemic steroid therapy.
- •- Patients who are judged by the Investigator to have a tumor at a site where a serious complication may occur due to needle catheter puncture and irradiation with a cylindrical diffuser.
- •- Patients with a CNS primary malignancy or CNS metastasis.
- •- Patients with carcinomatous meningitis.
- •- Patients who developed malignancy other than the target disease within 5 years before study initiation.
- •- Patients with a history and complications of serious cardiovascular disease.
- •- Patients with any of the following conditions related to the heart.
- •QT interval, QTc interval is > 480 msec.
- •Patients who have a history or complication of congenital QT prolongation syndrome or torsade de pointes.
- •- Known to have clinically significant hepatic disease.
- •- Known to have ascites that would make laser-illumination to the hepatic lesion difficult.
- •- Have a history of allogenic bone marrow transplantation or solid organ transplantation.
- •- Need to be treated with systemic steroids or systemic immunosuppressants for the treatment of autoimmune disease within 90 days before enrollment.
- •- Known history of testing positive for human immunodeficiency virus infection or acquired immunodeficiency syndrome-related diseases.
- •- Known detection of active or latent hepatitis B or hepatitis C.
- •- Known history of testing positive for qualitative HTLV-1.
- •- Received an attenuated live vaccine within 4 weeks before initial RM-1995 treatment (for treatment with RM-1995 PIT alone) or initial pembrolizumab treatment (for treatment with RM-1995 PIT in combination with pembrolizumab), or anticipated to receive an attenuated live vaccine during the study period.
- •- Require anti-platelet drugs, anticoagulants or thrombolytic drugs during the study period, which would increase the risk of bleeding.
- •- Patients with uncontrolled complications.
- •- Patients with active infections.
- •- Patients who underwent major surgery within 28 days prior to initial RM-1995 treatment (for treatment with RM-1995 PIT alone) or initial pembrolizumab treatment (for treatment with RM-1995 PIT in combination with pembrolizumab) or anticipated to undergo major surgery unrelated to the study intervention during the study period.
- •- Have a history of severe allergic, anaphylactic, or other hypersensitivity reactions to RM-1995, basiliximab, pembrolizumab, or any component of other monoclonal antibodies.
- •- Have a history of treatment with RM-1995 PIT or who are deemed inappropriate as candidates to receive RM-1995 PIT or pembrolizumab (for combination therapy with RM-1995 PIT and pembrolizum
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