Radiopharm Theranostics Receives Positive Recommendation from Data Safety and Monitoring Committee (DSMC) to Accelerate 177Lu-RAD202 Phase 1 ‘HEAT’ Dose Escalation Clinical Trial
Radiopharm Theranostics (NASDAQ: RADX) received a positive recommendation from the Data Safety and Monitoring Committee (DSMC) to advance its Phase 1 'HEAT' clinical trial of 177Lu-RAD202 to a higher dose level. The trial, targeting HER2-positive advanced solid tumors, will progress to 75mCi dosing, skipping the planned 40mCi level after successful completion of the first 30mCi cohort.
The DSMC's review confirmed positive safety, pharmacokinetic, and biodistribution data from the initial cohort. The company expects to enroll the second cohort by Q4 2025 and remains on track to share data from the first two cohorts by year-end 2025. The study is being conducted across clinical centers in Australia.
Radiopharm Theranostics (NASDAQ: RADX) ha ricevuto una raccomandazione positiva dal Data Safety and Monitoring Committee (DSMC) per avanzare il suo studio di fase 1 'HEAT' clinico di 177Lu-RAD202 verso un livello di dosaggio superiore. Lo studio, mirato a tumori solidi avanzati HER2-positivi, proseguirà con una dose di 75 mCi, saltando il livello previsto di 40 mCi dopo il successo del primo cohorte da 30 mCi.
La revisione del DSMC ha confermato dati di sicurezza positivi, farmacocinetica e biodistribuzione dalla coorte iniziale. L'azienda prevede di arruolare la seconda coorte entro il Q4 2025 e resta in linea per condividere i dati delle prime due coorti entro la fine del 2025. Lo studio è condotto in centri clinici in Australia.
Radiopharm Theranostics (NASDAQ: RADX) recibió una recomendación positiva del Comité de Seguridad de Datos y Supervisión (DSMC) para avanzar su ensayo clínico de Fase 1 'HEAT' de 177Lu-RAD202 a un nivel de dosis superior. El ensayo, dirigido a tumores sólidos avanzados HER2-positivos, progresará con una dosis de 75 mCi, omitiendo el nivel planificado de 40 mCi tras la exitosa finalización de la primera cohorte de 30 mCi.
La revisión del DSMC confirmó datos positivos de seguridad, farmacocinética y biodistribución de la cohorte inicial. la empresa espera inscribir la segunda cohorte para el Q4 2025 y continúa en camino para compartir datos de las primeras dos cohortes para finales de 2025. El estudio se está llevando a cabo en centros clínicos en Australia.
Radiopharm Theranostics (NASDAQ: RADX)는 제1상 'HEAT' 임상시험에서 177Lu-RAD202를 더 높은 용량으로 올리기 위해 데이터 안전성 및 모니터링 위원회(DSMC)로부터 긍정적인 권고를 받았습니다. HER2-양성 진행성 고형 종양을 대상으로 하는 이 시험은 첫 30mCi 코호트의 성공적 완료 후 예정된 40mCi 단계를 건너뛰고 75mCi 용량으로 진행될 예정입니다.
DSMC의 검토는 초기 코호트의 안전성, 약물동태 및 생체분포 데이터가 긍정적임을 확인했습니다. 회사는 2025년 4분기까지 두 번째 코호트를 등록할 것으로 예상하며, 연말까지 처음 두 코호트의 데이터를 공유하겠다고 밝혔습니다. 이 연구는 호주 내 임상 센터에서 진행 중입니다.
Radiopharm Theranostics (NASDAQ: RADX) a reçu une recommandation positive du Data Safety and Monitoring Committee (DSMC) pour faire progresser son essai clinique de phase 1 'HEAT' de 177Lu-RAD202 vers un niveau de dose plus élevé. L’essai, visant les tumeurs solides avancées HER2-positives, progressera avec une dose de 75 mCi, en sautant le niveau prévu de 40 mCi après l’achèvement réussi de la première cohorte de 30 mCi.
L’examen du DSMC a confirmé des données positives sur la sécurité, la pharmacocinétique et la biodistribution de la cohorte initiale. L’entreprise prévoit d’ouvrir le recrutement de la deuxième cohorte d’ici le 4e trimestre 2025 et reste sur la bonne voie pour partager les données des deux premières cohortes d’ici à la fin de 2025. L’étude est menée dans des centres cliniques en Australie.
Radiopharm Theranostics (NASDAQ: RADX) erhielt eine positive Empfehlung des Data Safety and Monitoring Committee (DSMC), das Phase-1-HEAT-Studienversuch von 177Lu-RAD202 auf eine höhere Dosierungsstufe voranzutreiben. Der Versuch, der auf HER2-positive fortgeschrittene soliden Tumore abzielt, wird mit einer Dosis von 75 mCi fortgesetzt und überspringt die geplante 40 mCi-Stufe nach dem erfolgreichen Abschluss der ersten 30 mCi-Kohorte.
Die Überprüfung des DSMC bestätigte positive Sicherheits-, Pharmakokinetik- und Biodistributionsdaten der ersten Kohorte. Das Unternehmen rechnet damit, die zweite Kohorte bis Q4 2025 zu rekrutieren und bleibt auf Kurs, Daten aus den ersten beiden Kohorten bis Ende 2025 zu veröffentlichen. Die Studie wird in klinischen Zentren in Australien durchgeführt.
Radiopharm Theranostics (NASDAQ: RADX) تلقّت توصية إيجابية من لجنة السلامة والرقابة على البيانات (DSMC) للمضي قدماً في تجربة المرحلة الأولى 'HEAT' لـ 177Lu-RAD202 إلى مستوى جرعة أعلى. التجربة، التي تستهدف الأورام الصلبة المتقدمة الإيجابية لـ HER2، ستتقدم بجرعة 75 mCi، متجاوزة المستوى المخطط له 40 mCi بعد نجاح إكمال المجموعة الأولى 30 mCi.
مراجعة DSMC أكدت سلامة إيجابية وبيانات PK وتوزيع الأدوية من المجموعة الأولية. تتوقع الشركة إكمال تسجيل المجموعة الثانية بحلول الربع الرابع من 2025 وتبقى على المسار ذاته لـ مشاركة بيانات من المجموعتين الأوليين بحلول نهاية عام 2025. الدراسة تُنفّذ في مراكز طبية في أستراليا.
Radiopharm Theranostics (纳斯达克股票代码：RADX) 收到了数据安全与监测委员会（DSMC）的积极建议，将其 1 期“HEAT”临床试验的 177Lu-RAD202 推进到更高剂量水平。该试验针对 HER2 阳性的晚期实体瘤，将以 75 mCi 的剂量推进，跳过计划中的 40 mCi 水平，此举是在首批 30 mCi 队列成功完成后进行。
DSMC 的评审确认了初始队列的安全性、药代动力学和生物分布数据呈阳性。公司预计在 2025 年第四季度前招募第二队列，并保持按计划在 2025 年底前分享前两个队列的数据。该研究在澳大利亚的临床中心进行。
- Accelerated dose escalation approved by DSMC, skipping intermediate dose level
- Positive safety, pharmacokinetic, and biodistribution data from first cohort
- Trial progressing rapidly since initial dosing in June
- On track for data readout from first two cohorts by year-end 2025
- None.
Insights
Radiopharm's Phase 1 trial shows promising safety allowing dose escalation from 30mCi to 75mCi, skipping the planned 40mCi interim step.
Radiopharm Theranostics has received an important vote of confidence from its Data Safety and Monitoring Committee for its radiotherapeutic asset 177Lu-RAD202. The DSMC has not only cleared the company to proceed to the next dose level in its Phase 1 'HEAT' trial but has also recommended accelerating to 75mCi instead of the originally planned 40mCi dose - a significant jump that suggests compelling initial safety data.
This acceleration is particularly noteworthy for a radioligand therapy trial, where careful dose escalation is typically mandatory due to potential radiation toxicity concerns. The DSMC's willingness to bypass an intermediate dose level indicates that the safety profile at 30mCi was remarkably clean, with favorable pharmacokinetics and biodistribution.
For context, radioligand therapies like 177Lu-RAD202 work by delivering targeted radiation to HER2-positive cancer cells while minimizing exposure to healthy tissue. The HER2 target is well-validated in breast cancer but remains challenging in other solid tumors where expression can be heterogeneous. Radiopharm's approach could potentially address HER2-positive cancers across multiple tumor types.
The accelerated timeline, with initial dosing in June and expected completion of the second cohort by Q4 2025, demonstrates operational efficiency in patient recruitment and data collection. The company appears on track to report data from the first two cohorts by year-end, which will provide crucial insights into whether 177Lu-RAD202 can join the growing arsenal of radioligand therapies showing promise in solid tumors.
Phase 1 study to progress to the next dose level of 75mCi in patients with HER2+ advanced solid tumors, instead of the protocol-planned dose of 40mCi
SYDNEY, Oct. 01, 2025 (GLOBE NEWSWIRE) -- Radiopharm Theranostics (ASX: RAD, Nasdaq: RADX, “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 received a positive recommendation from the Data Safety and Monitoring Committee (DSMC) to advance its clinical-stage radiotherapeutic asset, 177Lu-RAD202 (RAD202), to the next dose level of 75mCi in the Phase 1 ‘HEAT’ clinical trial in patients with Human Epidermal Growth Factor Receptor 2 (HER2)-positive advanced solid tumors. The DSMC is a multidisciplinary committee that conducts detailed reviews of study data, discusses potential safety events and provides recommendations regarding trial continuation.
“We are encouraged by the rapid progress of the Phase 1 ‘HEAT’ trial of RAD202 as it underscores the strong interest in new, effective therapeutic options to treat HER2-positive advanced and metastatic cancers an area of high unmet medical need,” said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. “With initial dosing in June and the swift completion of the first cohort, the DSMC’s recommendation to advance to a higher dose level marks an important step toward identifying the optimal Phase 2 dose and the recognition of very encouraging initial safety signals. Each cohort brings us closer to confirming RAD202’s safety profile and to demonstrating its potential to offer a new treatment option for patients with HER2-positive advanced solid tumors. We remain on track to share data from the first two cohorts by year-end 2025.”
The DSMC reviewed the first cohort of patients treated with 30mCi of Lu177-RAD202 and confirmed there was positive safety, pharmacokinetic, and biodistribution data and agreed that the study may continue without modifications and accelerate to the second cohort of patients at 75mCi of Lu177-RAD202. The second cohort of patients is expected to be enrolled by Q4 2025.
The Phase 1 ‘HEAT’ study is currently being conducted at clinical centers across Australia.
About 177Lu-RAD202:
RAD202 is a proprietary single domain monoclonal antibody (sdAb) that targets the Human Epidermal Growth Factor Receptor 2 (HER2)-positive expression in advanced solid tumors. HER2 is overexpressed in breast cancer and several other solid tumors and represents a validated target in oncology. In a previous diagnostic study of ten HER2-positive breast cancer patients, RAD202 demonstrated clinical proof-of-concept and had positive safety and biodistribution.
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 three Phase 1 trials in a variety of solid tumor cancers including lung, breast, and brain. Learn more at radiopharmtheranostics.com.
Authorized on behalf of the Radiopharm Theranostics Board of Directors by Executive Chairman Paul Hopper.
For more information:
Investors:
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
Media:
Matt Wright
NWR Communications
P: +61 451 896 420
E: matt@nwrcommunications.com.au
Follow Radiopharm Theranostics:
Website – https://radiopharmtheranostics.com/
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LinkedIn – https://www.linkedin.com/company/radiopharm-theranostics/
InvestorHub – https://investorhub.radiopharmtheranostics.com/
FAQ
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