Solid Tumors that Relapsed or Metastasized after Standard Therapy
Conditions
Interventions
investigational material(s)
Generic name etc : FF-21101In,FF-21101Y
INN of investigational material : -
Therapeutic category code : 43- Radioactive medicines
Dosage and Administration for Investigatio
Sponsors
PDRadiopharma Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (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.
Exclusion criteria
Exclusion criteria: (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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety pharmacokinetics other Safety:Adverse events Others:Tolerability, Dosimetry of FF-21101In and FF-21101Y. | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy Efficacy: Objective response rate (ORR) | — |
Countries
Japan
Outcome results
None listed