Radiopharm Theranostics Receives Approval to Initiate Phase 1 Therapeutic Trial of RAD 402 (KLK3-mAb with Tb161) in Advanced Prostate Cancer
Radiopharm Theranostics (ASX:RADX) received Bellberry Human Research Ethics Committee approval on November 18, 2025 to start a First‑In‑Human Phase 1 trial of RAD 402, an anti‑KLK3 monoclonal antibody radiolabelled with 161Tb for metastatic or locally advanced prostate cancer.
Preclinical biodistribution in mouse xenografts showed strong tumour targeting, limited bone and marrow uptake, and hepatic excretion. Radiopharm has supply agreements with Terthera (2022) for 161Tb production and Cyclotek (2025) for radiolabelling RAD 402, supporting trial initiation.
Radiopharm Theranostics (ASX:RADX) ha ottenuto l'approvazione del Bellberry Human Research Ethics Committee in data 18 novembre 2025 per avviare uno studio di Fase 1 First‑In‑Human di RAD 402, un anticorpo monoclonale anti‑KLK3 radiomarcato con 161Tb per il cancro della prostata metastatico o localmente avanzato.
La biodistribuzione preclinica in xenotrapi di topo ha mostrato un forte targeting tumorale, un'accettazione limitata in osso e midollo e escrezione epatica. Radiopharm ha accordi di fornitura con Terthera (2022) per la produzione di 161Tb e Cyclotek (2025) per la radiolabeling di RAD 402, a supporto dell'inizio della trial.
Radiopharm Theranostics (ASX:RADX) recibió la aprobación del Comité de Ética en Investigación Humana de Bellberry el 18 de noviembre de 2025 para iniciar un ensayo de Fase 1 First-In-Human de RAD 402, un anticuerpo monoclonal anti‑KLK3 radiomarcado con 161Tb para cáncer de próstata metastásico o localmente avanzado.
La biodistribución preclínica en xenoinjertos de ratón mostró un fuerte direccionamiento tumoral, una captación limitada en hueso y médula y excreción hepática. Radiopharm tiene acuerdos de suministro con Terthera (2022) para la producción de 161Tb y Cyclotek (2025) para el radiomarcaje de RAD 402, apoyando el inicio del ensayo.
Radiopharm Theranostics (ASX:RADX)는 Bellberry 인간 연구윤리심의위원회로부터 2025년 11월 18일 자로 승인을 받아 전이성 또는 국소 진행된 전립선암을 위한 RAD 402의 161Tb로 방사성 표지된 anti‑KLK3 단일클론항체의 First-In-Human 1상 시험을 시작합니다.
마우스 이종이식에서의 전임상 생체분포 연구는 강한 종양 표적화, 뼈와 골수의 제한적 섭취, 간 배설을 보였습니다. Radiopharm은 161Tb 생산을 위한 Terthera(2022) 및 RAD 402의 방사표지화에 대한 Cyclotek(2025)와의 공급 계약으로 시험 시작을 지원합니다.
Radiopharm Theranostics (ASX:RADX) a reçu l'approbation du comité d'éthique en recherche humaine Bellberry le 18 novembre 2025 pour démarrer un essai de phase 1 First‑In‑Human de RAD 402, un anticorps monoclonal anti‑KLK3 radiomarqué avec 161Tb pour le cancer de la prostate métastatique ou localement avancé.
La biodistribution préclinique dans des xénogreffes murines a montré un fort ciblage tumoral, une faible accumulation osseuse et médullaire, et une excrétion hépatique. Radiopharm a des accords d'approvisionnement avec Terthera (2022) pour la production de 161Tb et Cyclotek (2025) pour le radiolabeling de RAD 402, soutenant le démarrage de l'essai.
Radiopharm Theranostics (ASX:RADX) erhielt am 18. November 2025 vom Bellberry Human Research Ethics Committee die Genehmigung, eine First-In-Human Phase-1-Studie von RAD 402 zu beginnen, einem anti-KLK3‑Monoklonalantibody, das mit 161Tb radiomarkiert ist, für metastatischen oder lokal fortgeschrittenen Prostatakrebs.
Die präklinische Biodistribution in Maus-Xenografts zeigte starke Tumor-targeting, eine begrenzte Aufnahme in Knochen und Knochenmark sowie hepatische Ausscheidung. Radiopharm hat Lieferverträge mit Terthera (2022) für die 161Tb-Produktion und Cyclotek (2025) für das Radiolabeling von RAD 402, die den Studienstart unterstützen.
Radiopharm Theranostics (ASX:RADX) تلقّى موافقة لجنة أخلاقيات البحث البشري Bellberry في 18 نوفمبر 2025 للبدء في تجربة من المرحلة الأولى First-In-Human من RAD 402، وهو جسم مضاد أحادي النسيلة مضاد لـKLK3 مُشعّ بالـ 161Tb لعلاج سرطان البروستاتا المتنَسِّر أو المحلّي المتقدم.
أظهرت التوزيع الحيوي قبل السريرية في نماذج فأرية وجود استهداف قوي للورم، واقتناء محدود للعظام ونخاع العظم، وإخراج كبدي. لدى Radiopharm اتفاقيات توريد مع Terthera (2022) لإنتاج 161Tb ومع Cyclotek (2025) لتسمية RAD 402 إشعاعياً، مما يدعم بدء التجربة.
- HREC approval granted to start Phase 1 trial (Nov 18, 2025)
- Preclinical strong tumour targeting in mouse xenografts
- Signed supply agreements with Terthera (2022) and Cyclotek (2025)
- RAD 402 is at Phase 1 first‑in‑human stage; clinical efficacy not yet established
- Preclinical data limited to mouse xenografts, not clinical outcomes
Insights
HREC approval clears first-in-human Phase 1 start for a KLK3-targeting Tb-161 antibody in advanced prostate cancer.
RAD 402 combines a humanized anti-KLK3 IgG1 with the radionuclide 161Tb, and HREC approval on
Primary dependencies and risks are explicit and limited to facts disclosed: the trial still must demonstrate human safety and any therapeutic signal; regulatory and operational steps beyond HREC approval remain. Watch for initial safety and tolerability readouts, dosing escalation details, and early biomarker changes such as PSA during the Phase 1 study; these milestones will drive near-term clinical value. Expect these readouts to appear on standard Phase 1 timelines following the HREC clearance.
RAD 402 is a humanized IgG1 internalized by prostate cells, binding KLK3 with high affinity
Tb-161 antitumor activity driven by the dual emission of beta particles and Auger electrons
SYDNEY, Nov. 18, 2025 (GLOBE NEWSWIRE) -- 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 it has been granted Bellberry Human Research Ethics Committee (HREC) approval in Australia to initiate its First-In-Human (FIH) Phase 1 clinical trial of its Kallikrein Related Peptidase 3 (KLK3)-targeting radiotherapeutic, RAD 402, for the treatment of metastatic or locally advanced prostate cancer.
RAD 402 is an anti-KLK3 monoclonal antibody radiolabelled with the radionuclide 161Tb 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 expressed in the prostate along with most adenocarcinomas of the prostate including their metastases.
Previous comprehensive preclinical proof-of-concept Biodistribution studies of RAD 402 in mouse xenografts showed strong tumour targeting, limited bone and marrow uptake, and a hepatic excretion profile consistent with expectations for a monoclonal antibody. Radiopharm has signed in 2022 a supply agreement with Terthera for the production of Tb161 and in 2025 with Cyclotek for radiolabeling RAD402 with 161Tb, supporting the initiation of the Phase 1 FiH trial of RAD 402.
“Receiving HREC approval marks a key milestone for Radiopharm and for patients in need of safer, more effective new treatments for prostate cancer,” said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. “This clearance enables us to advance RAD 402 into our first-in-human Phase 1 clinical trial, which, to my knowledge, is the first company-sponsored therapeutic trial using 161Tb. We are highly encouraged by RAD 402’s potential antitumor activity, driven by the dual emission of beta particles and Auger electrons from Tb-161. Targeting KLK3 in advanced prostate cancer represents a novel and promising mechanism of action. The strength of our preclinical data, combined with regulatory endorsement, underscores RAD 402’s first-in-class potential.”
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, 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:
Riccardo Canevari
CEO & Managing Director
P: +1 862 309 0293
E: rc@radiopharmtheranostics.com
Anne Marie Fields
Precision AQ (Formerly Stern IR)
E: annemarie.fields@precisionaq.com
Paul Hopper
Executive Chairman
P: +61 406 671 515
E: paulhopper@lifescienceportfolio.com
Media
Matt Wright
NWR Communications
P: +61 451 896 420
E: matt@nwrcommunications.com.au
FAQ
What did Radiopharm (RADX) announce on November 18, 2025 about RAD 402?
What is RAD 402 and how does it work in prostate cancer?
What preclinical results support Radiopharm's RAD 402 trial (RADX)?
Who supplies the 161Tb and radiolabelling for RAD 402 (RADX)?
What patient population will the RAD 402 Phase 1 trial target?
