Clinical Trial · NCT07259213

A Study of Terbium 161 (161Tb)-RAD402 in Participants With CRPC

Overview

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).

Sponsor

Radiopharm Theranostics

Phase

Phase 1/2

Contacts

Dimitris Voliotis, MD (CONTACT)

dv@radiopharmtheranostics.com

646-535-5017

ClinicalTrials.gov

NCT07259213

Drug / Compound

RAD402

Isotope(s):

Target(s):

PSMA

Ligand Class: Antibodies

Eligibility

Inclusion

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)
* 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.
Participants with a documented history of histopathologically confirmed locally advanced or metastatic CRPC defined as follows:
Progressive CRPC defined as castrate levels of testosterone and progressing by at least one of the following criteria:

Exclusion

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.
Residual toxicity ≥ Grade 2 from prior anti-cancer therapy (except alopecia and peripheral sensory neuropathy).
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.
* Prostate cancer with known significant sarcomatoid, or spindle cell, or neuroendocrine small cell components, or metastasis of other cancer to the prostate.

Patient Education

Patient education not yet provided.

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