Full Press Release Details
Theranostics Doses First Patient in Phase 1 Clinical Study of RAD 402 in Advanced Prostate Cancer
On track to share data from first two dose levels
Targeting KLK3 and leveraging the dual emission
of Tb161 represents an innovative approach for radiotherapies in Prostate Cancer
Preclinical proof-of-concept mouse xenografts
demonstrated RAD 402's strong tumor targeting with minimal bone/marrow uptake and expected hepatic clearance
Sydney, Australia - 27 March 2026 - Radiopharm Theranostics
(ASX:RAD, "Radiopharm" or the "Company"), a clinical-stage biopharmaceutical company focused on developing innovative
oncology radiopharmaceuticals for areas of high unmet medical need, today announced that the first patient has been dosed in its first-in-human
Phase 1 clinical trial of RAD 402, a monoclonal antibody targeting KLK3 radiolabelled with Terbium 161 being evaluated in advanced prostate
The Phase 1 clinical trial (NCT07259213)
is designed to study the safety, tolerability, whole-body distribution, and preliminary clinical activity of RAD 402 in patients with
advanced prostate cancer. The dose escalation Phase 1 study is designed to determine the Maximum Tolerated Dose (MTD) and/or recommended
phase 2 dose (RP2D) for expansion.
"Dosing the first patient in our Phase 1 study of RAD 402 marks
an important step forward for Radiopharm and for patients with advanced prostate cancer," said Riccardo Canevari, CEO and Managing
Director of Radiopharm Theranostics. "RAD 402 is a differentiated, first-in-class, next-generation radiotherapeutic designed to
selectively target KLK3-expressing tumors while minimizing off-target exposure. With preclinical data demonstrating strong tumor uptake
and minimal bone or marrow involvement, we are optimistic about its potential clinical profile. Advancing this program into the clinic
reflects our continued commitment to delivering meaningful data across our portfolio this year. I like to take the opportunity to thank
our partners, TerThera and Cyclotek, for the great support in supplying Tb161, radiolabelling, and distributing RAD 402."
RAD 402 (NCT07259213) is an anti-KLK3 monoclonal antibody radiolabelled
with the radionuclide 161Tb that is being evaluated in a Phase 1/2a clinical trial for the treatment of prostate cancer. Prostate Specific
Antigen (PSA) is a widely used biomarker to detect prostate cancer and is encoded by the KLK3 gene. KLK3 is highly expressed in prostate
cancer cells along with most adenocarcinomas of the prostate including their metastases and has limited expression in sites outside of
the prostrate. Preclinical proof-of-concept biodistribution studies of RAD 402 in mouse xenografts showed strong tumor targeting, limited
bone and marrow uptake, and a hepatic excretion profile consistent with expectations for a monoclonal antibody.
Radiopharm Theranostics Limited
Suite 1, Level 3, 62 Lygon Street, Carlton South VIC 3053 Australia
About Radiopharm Theranostics
Radiopharm Theranostics is a clinical stage radiotherapeutics company
developing a world-class platform of innovative radiopharmaceutical products for diagnostic and therapeutic applications in areas of high
unmet medical need. Radiopharm is listed on ASX (RAD) and on NASDAQ (RADX). The company has a pipeline of distinct and highly differentiated
platform technologies spanning peptides, small molecules and monoclonal antibodies for use in cancer. The clinical program includes one
Phase 2 and four Phase 1 trials in a variety of solid tumor cancers including lung, breast, prostate and brain metastases. Learn more
at radiopharmtheranostics.com.
Authorised on behalf of the Radiopharm Theranostics board of directors by Chairman Paul Hopper.
For more information:
CEO & Managing Director
Precision AQ (Formerly Stern IR)
Radiopharm Theranostics
Suite 1, Level 3, 62 Lygon Street, Carlton South VIC 3053 Australia