About this trial
A Phase 1/2a Study to Evaluate the Safety, Tolerability, Whole-Body Distribution, and Preliminary Clinical Activity of 161Tb-RAD402, a Radiolabeled Anti-KLK3 Monoclonal Antibody Targeting Free Prostate-Specific Antigen, in Participants with Castration-Resistant Prostate Cancer (CRPC).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Willing and able to provide informed consent prior to start of any study procedures and assessments and must be willing to comply with all study procedures.
Male participants ≥ 18 years of age.
Serum PSA increase >25% and >2.0 ng/ml above nadir, confirmed by progression at 2 timepoints at least 3 weeks apart (PCWG3)
Soft tissue progression defined as a ≥20% increase in the sum of the diameter (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest sum of the diameter since the previous treatment was started or the appearance of one or more new lesions by computed tomography (CT)/ magnetic resonance imaging (MRI).
Disqualifiers
Prostate cancer with known significant sarcomatoid, or spindle cell, or neuroendocrine small cell components, or metastasis of other cancer to the prostate.
History of prior organ transplant (other than corneal transplant)
Any other known, active malignancy except for non-melanoma skin cancer or adequately treated non-muscle-invasive urothelial carcinoma of the bladder (i.e. tumor in situ (Tis), tumor grade a (Ta) and low-grade tumor grade 1 (T1) tumors). Participants with a history of malignancies of low recurrence potential who have received curative-intent therapy may be approved on a case-by-case basis in discussion with the Sponsor, if it is determined not to put the participant at an increased risk of adverse drug effects and/or interfere with the integrity of the study outcome.
Have any medical condition that would, in the Investigator's judgment, prevent the participant's full participation in the clinical study due to safety concerns or compliance with clinical study procedures such as participants with severe claustrophobia who are unresponsive to oral anxiolytics, participants with low back pain who cannot lie comfortably on an imaging table, participants who are hyperactive or hyperkinetic such that they cannot tolerate lying still for multiple time point imaging procedures, etc.
Trial design
Single group
Treatments tested in this trial
161Tb RAD402
Drug161Tb RAD402 administered at treatment doses
Treatment groups
Trial outcomes
Primary outcomes
Incidence of treatment emergent adverse events of 161Tb RAD402 (phase 1) (Safety)
As defined per Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Recommended dose(s) of 161Tb RAD402 for future exploration (phase 1)
Incidence of dose-limiting toxicities (DLTs) during the first 6 weeks following the first 161Tb RAD402 injection
Preliminary anti-tumor activity, as defined by biochemical response, in participants who are treated with 161Tb RAD402 at the RP2D (phase 2a)
Proportion of participants who achieve a ≥50% decline in prostate-specific antigen (PSA) 50
Secondary outcomes
Preliminary anti-tumor activity of 161Tb RAD402 (phase 1)
As assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Preliminary anti-tumor activity of 161Tb RAD402 as defined by biochemical response (phase 1)
Proportion of participants who achieve a ≥50% decline in prostate-specific antigen (PSA) 50
Pharmacokinetics of 161Tb RAD402 (phase 1)
Half-life of 161Tb RAD402 in blood
Radiation dosimetry of 161Tb RAD402 (phase 1)
Absorbed radiation doses of 161Tb RAD402 in critical organs (e.g., kidneys, bone marrow)
Sponsors and contacts
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