Cancer Clinical Trial
Official title:
A Phase 1, Multi-Center, Open-Label, Dose Escalation Study of I-131-CLR1404 in Subjects With Relapsed or Refractory Advanced Solid Malignancies
The purpose of this study is to determine the recommended dose of I-131-CLR1404, a
radiolabeled therapy compound, for treating subjects with cancer that does not respond to
treatment or has returned. The identified recommended dose in this study will be used as the
optimal dose of I-131-CLR1404 in subsequent clinical trials conducted for later phase
clinical development.
Subjects who meet study entry criteria will receive I-131-CLR1404. For each subject, the
study will be conducted in two phases, dosimetric and therapy. In the dosimetric phase,
subjects will receive one 5 mCi dose of the study drug and undergo whole body imaging on on
the day of infusion and on post-infusion days 1, 2, 3, and 6 for assessment of
biodistribution of I-131-CLR1404. If normal and expected biodistribution are demonstrated,
the subject will begin the therapy phase. In the therapy phase, the first cohort of subjects
will receive a dose of 12.5 mCi/m2. Dose escalation in subsequent cohorts will initially be
in increments of 12.5 mCi/m2. Subjects will be followed and observed for unacceptable
toxicity through 56 days after the therapy dose infusion with follow-up for up to one year.
All subjects will be prescribed thyroid protection medication to be taken 24 hours prior to
injection of the dosimetric dose, and continuing for 14 days after the administration of the
therapy dose.
n/a
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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