JPRN-jRCT2080225141已完成1 期
A Phase 1, Single Site, Open-label, Uncontrolled Study of FF-21101In / FF-21101Y in Patients with Solid Tumors that Relapsed or Metastasized after Standard Therapy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
研究概览
简要总结
either deaths nor other SAE occurred after FF-21101In and 555 MBq/m2 FF-21101Y administration. No severe TEAEs other than hematotoxicity occurred. Tolerability was unable to be evaluated due to insufficient cases. No radiation doses exceeded the tolerable levels in any organs/tissues. The PK specific to antibody therapies were demonstrated. No subjects showed therapeutic response. Safety, efficacy, and PK of FF-21101Y at 925 MBq/m2 were unable to be evaluated, making overall evaluation impossible.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •(1)Patients conforming to any of 1) to 3) below
- •1)Has ovarian carcinoma to which all of a) to c) below.
- •a)Has any of histopathologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
- •b)The possibility of ovarian borderline malignancy has been ruled out.
- •c)Has platinum resistance with which relapse occurred in less than 6 months after completion of chemotherapy that included platinum.
- •2)Has biliary tract carcinoma to which all of a) to c) below.
- •a)Has any of intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder carcinoma, or papillary carcinoma confirmed on CT, MRCP, or other testing.
- •b)Surgically unresectable.
- •c)Deemed unresponsive to or intolerant of regimens that included gemcitabine.
- •3)Has head and neck squamous cell carcinoma to which all of a) to c) below.
- •a)Has histopathologically confirmed head and neck squamous cell carcinoma.
- •b)The primary site is the maxillary sinus, oral cavity, epipharynx, oropharynx, hypopharynx, or larynx.
- •c)Experienced relapse or metastasis after chemotherapy that included platinum or after treatment with nivolumab.
- •(2)Had no more than 4 previous chemotherapy regimens.
- •(3)Has at least one measurable lesion by CT or MRI according to RECIST v.1.1 (long axis >10 mm for tumors; short axis>15 mm for lymph node lesions).
- •(4)Expected survival of>6 months.
排除标准
- •(1)Had chemotherapy (including antibody therapy), surgery, or external radiation therapy within 4 weeks prior to FF-21101In administration.
- •(2)Administered other investigational products within 12 weeks prior to FF-21101In administration.
- •(3)Previously received internal radiation therapy.
- •(4)Has a history of severe hypersensitivity to components of FF-21101In / FF-21101Y
- •(5)Previously received external radiation therapy to any organ up to minimal tolerable dose (TD5/5, radiation dose that could cause no more than a 5% severe complication rate within 5 years of treatment).
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