This is an imaging trial, to develop h11B6 as a therapeutic radiopharmaceutical for men
with mCRPC.
This imaging study will be conducted to confirm the safety and estimate the mass amount
of antibody h11B6, and confirm in vivo tumor targeting of the antibody, using Indium-111
(111In) radiolabeled h11B6 in subjects with advanced prostate cancer. This study will
also provide the dosimetric information crucial for Phase 1 therapy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04116164.
It is the intent to develop h11B6 as a therapeutic radiopharmaceutical for men with
mCRPC. This Phase 0 study will be conducted to confirm the safety, estimate the mass
amount, and confirm in vivo tumor targeting of the antibody. This study will use
Indium-111 (111In) radiolabeled h11B6 in subjects with mCRPC to image known sites of
disease and identify a favorable mass amount of antibody for satisfactory tumor targeting
with minimal/no accumulation off-target. In cohort 1, In-111 labeled h11B6 will remain
fixed at 2 mg, and additional h11B6 will be added in 2 sub-cohorts (8 mg and 18 mg
respectively); up to 6 patients may be entered into a sub-cohort. Additional patients (up
to 6) will be studied once the most favorable mass and imaging time point have been
established, to establish targeting of antibody to known disease.
This study will provide the dosimetric information crucial for Phase 1 therapy.
Trial PhasePhase O
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationSpectronRX
