Radiopharm Theranostics Announces 50% Enrollment in Phase 2b Clinical Trial of RAD101 Imaging in Brain Metastases
Radiopharm Theranostics (ASX:RADX) announced that its Phase 2b trial of RAD101 for imaging brain metastases has reached 50% patient enrollment and is expected to complete enrollment with topline data in 1H 2026. Early data from the first three patients showed significant, selective tumor uptake in brain metastases with metabolic activity visible where MRI was equivocal. RAD101 targets fatty acid synthase (FASN) and has U.S. FDA Fast Track designation to help distinguish recurrence from treatment effect. If Phase 2b findings are confirmed, the company plans to prepare a multi-center global Phase 3 registrational trial.
Key factual points:
- 50% enrollment achieved (Phase 2b)
- Topline data anticipated in 1H 2026
- Early 3-patient imaging showed selective uptake versus equivocal MRI
- RAD101 holds FDA Fast Track designation
Radiopharm Theranostics (ASX:RADX) ha annunciato che il suo trial di fase 2b di RAD101 per l'imaging delle metastasi cerebrali ha raggiunto il 50% dell'arruolamento ed è previsto completare l'iscrizione con i dati primari nell'I semestre 2026. I primi dati dai primi tre pazienti hanno mostrato un uptake tumorale significativo e selettivo nelle metastasi cerebrali con attività metabolica visibile dove l'MRI era equivoco. RAD101 punta su sintesi degli acidi grassi (FASN) e ha la designazione FDA Fast Track per distinguere recidiva da effetto del trattamento. Se i risultati di fase 2b saranno confermati, l'azienda intende preparare uno studio registrazionale globale di fase 3 multi-centro.
Punti chiave:
- Arruolamento al 50% raggiunto (fase 2b)
- Topline data attese nel 1H 2026
- Imaging di 3 pazienti iniziali ha mostrato uptake selettivo rispetto a MRI equivoca
- RAD101 possiede la designazione FDA Fast Track
Radiopharm Theranostics (ASX:RADX) anunció que su ensayo de fase 2b de RAD101 para imágenes de metástasis cerebrales ha alcanzado el 50% del reclutamiento y se espera completar la inscripción con datos principales en la primera mitad de 2026. Los datos preliminares de los primeros tres pacientes mostraron una captación tumoral significativa y selectiva en las metástasis cerebrales con actividad metabólica visible donde la RM era equívoca. RAD101 apunta a la síntesis de ácidos grasos (FASN) y tiene la designación FDA Fast Track para ayudar a distinguir recidiva de efecto del tratamiento. Si se confirman los hallazgos de la fase 2b, la compañía planea preparar un ensayo global, multicentro, de fase 3 registrativo.
Puntos clave:
- Arranque de reclutamiento al 50% logrado (fase 2b)
- Datos principales previstos en la 1H 2026
- Imágenes preliminares de 3 pacientes mostraron captación selectiva frente a MRI equívoca
- RAD101 posee designación FDA Fast Track
Radiopharm Theranostics (ASX:RADX)는 RAD101의 뇌 전이 이미징을 위한 2b상 임상에서 환자 등록의 50%를 달성했고 1H 2026에 topline 데이터를 포함한 등록 완료가 예상된다고 발표했습니다. 처음 세 명의 환자에서 얻은 초기 데이터는 뇌 전이 종양의 상당하고 선택적인 섭취를 보여주었으며 MRI가 애매했던 부분에서 대사 활성도가 보였습니다. RAD101은 지방산 합성효소(FASN)를 표적으로 하며 재발과 치료 효과를 구분하는 데 도움이 되는 미국 FDA의 패스트 트랙(Fast Track) 지정을 받았습니다. 2b상의 결과가 확인되면, 회사는 다기관 글로벌 3상 승인 임상을 준비할 계획입니다.
주요 사실:
- 등록률 50% 달성(2b상)
- 1H 2026에 topline 데이터 예상
- 처음 3명에서의 영상에서 MRI와 달리 선택적 섭취가 관찰됨
- RAD101는 FDA Fast Track 지정을 보유
Radiopharm Theranostics (ASX:RADX) a annoncé que son essai de phase 2b de RAD101 pour l’imagerie des métastases cérébrales a atteint 50% de l’inscription et devrait se terminer avec les données primaires dans la 1er semestre 2026. Les données précoces des trois premiers patients ont montré une uptake tumoral significatif et sélectif dans les métastases cérébrales avec une activité métabolique visible là où l’IRM était équivoque. RAD101 vise la synthèse des acides gras (FASN) et bénéficie d’une désignation FDA Fast Track pour aider à distinguer récidive et effet du traitement. Si les résultats de la phase 2b sont confirmés, la société prévoit de préparer un essai multicentrique mondial de phase 3 enregistrant.
Points clés :
- Inscription à 50% atteinte (phase 2b)
- Topline data attendues en 1H 2026
- Imagerie précoce de 3 patients montrant une uptake sélectif face à une IRM équivoque
- RAD101 détenant la désignation FDA Fast Track
Radiopharm Theranostics (ASX:RADX) gab bekannt, dass seine Phase-2b-Studie von RAD101 zur Bildgebung von Hirnmetastasen 50% der Patientenrekrutierung erreicht hat und die Rekrutierung voraussichtlich mit den Topline-Daten in der 1. Hälfte 2026 abgeschlossen wird. Erste Daten von den ersten drei Patienten zeigten signifikanten, selektiven Tumoraufnahme in Hirnmetastasen mit metabolischer Aktivität, sichtbar dort, wo das MRI uneindeutig war. RAD101 zielt auf Fettsäuresynthase (FASN) ab und verfügt über eine FDA Fast Track-Deklaration, um Rezidiv von Behandlungseffekt zu unterscheiden. Falls die Phase-2b-Ergebnisse bestätigt werden, plant das Unternehmen eine globale, multizentrische Phase-3-registratorische Studie.
Kerndaten:
- 50% Rekrutierung erreicht (Phase 2b)
- Topline-Daten voraussichtlich in der 1H 2026
- Frühe Bildgebung von 3 Patienten zeigte selektive Aufnahme gegenüber uneindeutiger MRI
- RAD101 verfügt über FDA Fast Track-Deklaration
Radiopharm Theranostics (ASX:RADX) أعلن أن تجربته من المرحلة 2b لـ RAD101 لتصوير النُّسُجات الدماغية المنتشرة وصلت إلى 50% من التسجيل ويُتوقع إكمال التسجيل مع بيانات رئيسية في النصف الأول من عام 2026. أظهرت البيانات المبكرة من أول ثلاثة مرضى ارتفاعاً ملحوظاً وانتقائياً في امتصاص الورم في النُسُجات الدماغية مع نشاط استقلابي ظاهر حيث كانت التصوير بالرنين المغناطيسي متردداً. RAD101 يستهدف حمض الخطِّيات الاصطناعية (FASN) ولديه تصنيف FDA Fast Track للمساعدة في تمييز الت recurrence عن تأثير العلاج. إذا تم تأكيد نتائج المرحلة 2b، تخطط الشركة لإعداد تجربة تسجيلية عالمية متعددة المراكز في المرحلة 3.
نقاط رئيسية:
- تحقيق 50% من التسجيل (المرحلة 2b)
- من المتوقع topline البيانات في 1H 2026
- تصوير مبكر لـ3 مرضى أظهر امتصاصاً انتقائياً مقارنة بـ MRI غير الحاسم
- RAD101 يحمل تصنيف FDA Fast Track
- Phase 2b 50% enrollment achieved
- Early imaging: selective tumor uptake in first three patients
- RAD101 has FDA Fast Track designation
- Topline data targeted for 1H 2026
- Early data limited to three patients
- Phase 3 preparation is contingent on confirming Phase 2b results
Insights
RAD101 hit a 50% enrollment milestone with encouraging early uptake in three patients and FDA Fast Track status.
RAD101, a FASN-targeted imaging agent from Radiopharm Theranostics, reached
Key dependencies and risks include confirmation of the early uptake signal across the full cohort and consistency versus MRI; the press release provides no quantitative uptake metrics, sensitivity/specificity data, or safety details, so conclusions remain provisional. The FDA Fast Track Designation supports regulatory engagement but does not imply approval.
Concrete items to watch are completion of enrollment and topline results in
Early patient data from Phase 2b clinical trial showed significant and selective tumor uptake in brain metastases compared to MRI
Phase 2b clinical trial expected to complete enrollment and have topline data in 1H26
SYDNEY, Nov. 17, 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 the Phase 2b trial evaluating RAD101 imaging in brain metastases has achieved
“Enrolling
RAD101 is the Company’s novel imaging small molecule that targets fatty acid synthase (FASN), a multi-enzyme protein that catalyses fatty acid synthesis and is overexpressed in many solid tumors, including Brain metastases.
Data from the first three patients showed significant and selective tumor uptake in brain metastases. Images confirmed metabolic activity in brain metastases compared to equivocal MRI findings. These promising early results are in line with the previously published Phase 2a results and, if confirmed, will trigger the preparation of a multi-center, global Phase 3 registrational trial.
In the U.S. alone, there are more than 300,000 patients diagnosed annually with cerebral metastases. The incidence of Intracranial Metastatic Disease (IMD) continues to increase, in part, due to improvements in systemic therapy resulting in a more durable control of the Primary tumor. Contrast-enhanced Magnetic Resonance Imaging (CE-MRI) is the preferred method for imaging IMD, but has limitations, particularly in follow-up surveillance scans to optimise patient care.1
RAD101 has received U.S. Food and Drug Administration (FDA) Fast Track Designation to distinguish between recurrent disease and treatment effect of brain metastases originating from solid tumors of different origin including leptomeningeal disease.
About the Phase 2 Clinical Trial of RAD101
The U.S. multicenter, open-label, single arm Phase 2b clinical trial is evaluating the diagnostic
performance of 18F-RAD101 in 30 individuals with confirmed recurrent brain metastases from solid
tumors of different origins. The primary objective of the study is concordance between 18F-RAD101
positive lesions and those seen in conventional imaging (MRI with gadolinium) in participants with
suspected recurrent brain metastases. Secondary endpoints are accuracy, sensitivity and specificity of RAD101 in identifying tumor recurrence versus radiation necrosis in previously stereotactic radiosurgery (SRS)-treated brain metastases.
About RAD101
RAD101 is the Company’s novel imaging small molecule that targets fatty acid synthase (FASN), a multi-enzyme protein that catalyses fatty acid synthesis and is overexpressed in many solid tumors, including cerebral metastasis. Targeting FASN activity may allow for the more accurate detection of cancer cells, representing a clinically relevant method for the imaging of brain metastases. Positive data from the Imperial College of London’s Phase 2a imaging trial of 18F-RAD101 in patients with brain metastases (both SRS pre-treated and treatment naïve patients) showed significant tumor uptake that was independent from the tumor of origin. The study further indicated that PET-MRI may potentially represent a non-invasive prediction of overall-survival, warranting larger studies.
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 milestone did Radiopharm Theranostics (RADX) announce on November 17, 2025?
When does Radiopharm expect topline RAD101 Phase 2b data for RADX?
What did early RAD101 imaging show compared with MRI in the RADX trial?
Does RAD101 have any special regulatory status for RADX in the U.S.?
Could RAD101 move to a Phase 3 registrational trial for RADX?
How many U.S. patients are cited as affected by cerebral metastases relevant to RADX?
