Radiopharm Theranostics Accelerates 177Lu-RAD204 Phase 1 Dose Escalation Clinical Trial Based on Positive Recommendation from Data Safety and Monitoring Committee (DSMC)
Radiopharm Theranostics (RADX) has received approval from the Data Safety and Monitoring Committee (DSMC) to proceed with dose escalation in its Phase 1 clinical trial of 177Lu-RAD204 for PD-L1 positive advanced cancers. The DSMC reviewed the first cohort of four patients treated with 30mCi and confirmed positive safety, pharmacokinetic, and biodistribution data.
The second cohort will receive an increased dose of 60mCi (higher than the previously planned 40mCi). The trial is expanding beyond Non-Small Cell Lung Cancer to include multiple tumor types such as Small-Cell Lung Cancer, Triple-negative Breast Cancer, Cutaneous Melanoma, head and neck cancer, and Endometrial Cancer. The company expects to complete enrollment of the first two cohorts by mid-2025, with four clinical trial sites actively recruiting in Australia.
Radiopharm Theranostics (RADX) ha ottenuto l'approvazione dal Data Safety and Monitoring Committee (DSMC) per procedere con l'aumento della dose nella sua sperimentazione clinica di Fase 1 di 177Lu-RAD204 per tumori avanzati positivi a PD-L1. Il DSMC ha esaminato il primo gruppo di quattro pazienti trattati con 30mCi, confermando dati positivi riguardo sicurezza, farmacocinetica e biodistribuzione.
Il secondo gruppo riceverà una dose aumentata di 60mCi (superiore ai 40mCi precedentemente previsti). Lo studio si sta ampliando oltre il carcinoma polmonare non a piccole cellule, includendo vari tipi di tumori come carcinoma polmonare a piccole cellule, carcinoma mammario triplo negativo, melanoma cutaneo, tumori della testa e del collo e carcinoma endometriale. L'azienda prevede di completare l'arruolamento dei primi due gruppi entro metà 2025, con quattro centri clinici attivi in Australia.
Radiopharm Theranostics (RADX) ha recibido la aprobación del Comité de Seguridad y Monitoreo de Datos (DSMC) para proceder con la escalada de dosis en su ensayo clínico de Fase 1 de 177Lu-RAD204 para cánceres avanzados positivos a PD-L1. El DSMC revisó la primera cohorte de cuatro pacientes tratados con 30mCi y confirmó datos positivos de seguridad, farmacocinética y biodistribución.
La segunda cohorte recibirá una dosis aumentada de 60mCi (superior a los 40mCi planificados inicialmente). El ensayo se está ampliando más allá del cáncer de pulmón no microcítico para incluir múltiples tipos de tumores como cáncer de pulmón microcítico, cáncer de mama triple negativo, melanoma cutáneo, cáncer de cabeza y cuello y cáncer endometrial. La empresa espera completar la inscripción de las dos primeras cohortes para mediados de 2025, con cuatro sitios de ensayo clínico reclutando activamente en Australia.
Radiopharm Theranostics (RADX)는 PD-L1 양성 진행성 암에 대한 177Lu-RAD204 1상 임상시험에서 용량 증량을 진행할 수 있도록 데이터 안전성 및 모니터링 위원회(DSMC)의 승인을 받았습니다. DSMC는 30mCi 용량으로 치료받은 첫 번째 코호트 4명의 환자를 검토하고 안전성, 약동학 및 생체 분포 데이터가 긍정적임을 확인했습니다.
두 번째 코호트는 이전에 계획된 40mCi보다 높은 60mCi 용량을 투여받을 예정입니다. 이 임상시험은 비소세포폐암을 넘어 소세포폐암, 삼중음성유방암, 피부 흑색종, 두경부암, 자궁내막암 등 다양한 종양 유형으로 확대되고 있습니다. 회사는 2025년 중반까지 첫 두 코호트의 등록을 완료할 것으로 예상하며, 호주 내 4개 임상시험 기관이 활발히 환자를 모집 중입니다.
Radiopharm Theranostics (RADX) a reçu l'approbation du Data Safety and Monitoring Committee (DSMC) pour procéder à l'augmentation de dose dans son essai clinique de phase 1 de 177Lu-RAD204 pour les cancers avancés positifs au PD-L1. Le DSMC a examiné la première cohorte de quatre patients traités avec 30mCi et a confirmé des données positives en matière de sécurité, pharmacocinétique et biodistribution.
La deuxième cohorte recevra une dose augmentée de 60mCi (supérieure aux 40mCi initialement prévus). L'essai s'élargit au-delà du cancer du poumon non à petites cellules pour inclure plusieurs types de tumeurs tels que le cancer du poumon à petites cellules, le cancer du sein triple négatif, le mélanome cutané, les cancers de la tête et du cou, ainsi que le cancer de l'endomètre. La société prévoit de terminer le recrutement des deux premières cohortes d'ici mi-2025, avec quatre sites d'essais cliniques actifs en Australie.
Radiopharm Theranostics (RADX) hat die Genehmigung des Data Safety and Monitoring Committee (DSMC) erhalten, die Dosiserhöhung in der Phase-1-Studie zu 177Lu-RAD204 bei PD-L1-positiven fortgeschrittenen Krebserkrankungen fortzusetzen. Das DSMC überprüfte die erste Kohorte von vier Patienten, die mit 30mCi behandelt wurden, und bestätigte positive Sicherheits-, Pharmakokinetik- und Biodistributionsdaten.
Die zweite Kohorte wird eine erhöhte Dosis von 60mCi erhalten (höher als die zuvor geplanten 40mCi). Die Studie wird über nicht-kleinzelligen Lungenkrebs hinaus auf mehrere Tumorarten ausgeweitet, darunter kleinzelliger Lungenkrebs, triple-negativer Brustkrebs, kutanes Melanom, Kopf-Hals-Tumoren und Endometriumkarzinom. Das Unternehmen erwartet, die Einschreibung der ersten beiden Kohorten bis Mitte 2025 abzuschließen, wobei vier klinische Studienzentren in Australien aktiv rekrutieren.
- Positive safety and efficacy data from first cohort allowing acceleration to higher dose
- DSMC approval to increase second cohort dose to 60mCi instead of planned 40mCi
- Expansion to multiple cancer types beyond NSCLC
- On track for completion of first two cohorts by mid-2025
- None.
Insights
Positive Phase 1 safety data for Radiopharm's 177Lu-RAD204 accelerates development timeline and expands to multiple cancer types.
The Data Safety Monitoring Committee's (DSMC) positive recommendation for Radiopharm's 177Lu-RAD204 represents a significant clinical milestone that bodes well for the program's progress. The clearance to advance directly to 60mCi dosing (skipping the previously planned 40mCi intermediate dose) indicates excellent initial safety data from the first cohort at 30mCi, suggesting a favorable therapeutic window for this radiopharmaceutical.
The expansion beyond Non-Small Cell Lung Cancer to include five additional cancer types (SCLC, TNBC, Melanoma, HNSCC, and Endometrial Cancer) is strategically sound as all have documented PD-L1 expression patterns. This broad tumor-agnostic approach could significantly expand the potential market opportunity if efficacy is demonstrated.
From a development timeline perspective, this acceleration is meaningful. With four active Australian trial sites and the dosing adjustment, completing enrollment of the second cohort by mid-2025 appears feasible. The expected data readout later in 2025 could provide preliminary insights into both safety and potential efficacy signals across multiple tumor types.
The radiotherapeutic approach targeting PD-L1 differs fundamentally from conventional checkpoint inhibitors, as it aims to directly deliver radiation to PD-L1 expressing tumors rather than blocking the PD-1/PD-L1 pathway. This differentiated mechanism could potentially address resistance to existing immunotherapies, representing a complementary rather than competitive approach in this established oncology space.
DSMC concluded that Phase 1 study may continue as planned without any modifications
On track to complete the enrollment of the first two cohorts by mid-2025
SYDNEY, May 12, 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, announced today that it has achieved a key milestone in its ongoing clinical development program for its clinical-stage radiotherapeutic asset, 177Lu-RAD204, as the Data and Safety Monitoring Committee (DSMC) has approved to proceed to the next dose in its Phase 1 clinical trial in patients with PD-L1 positive advanced cancers1. The DSMC is an independent multidisciplinary group that conducts detailed reviews of unblinded study data, discusses potential safety concerns and provides recommendations regarding trial continuation.
“We greatly appreciate the DSMC’s judicious review of our first cohort of patients in the Phase 1 study of 177Lu-RAD204, which allows us to advance to the higher dose cohort in a variety of PD-L1- driven cancers,” said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. “With this clearance from the DSMC, the increased number of active centers and expansion to multiple tumor types beyond Non-Small Cell Lung Cancer (NSCLC), we expect to accelerate our timelines for complete enrolment of the next cohort by mid-2025. We believe that RAD204 has the potential to strongly improve clinical outcomes for patients with PD-L1 positive advanced cancers and we look forward to seeing data from the first two cohorts of patients later this year.”
The DSMC reviewed the first cohort of four patients treated with 30mCi of 177Lu-RAD204 and confirmed that there was positive safety, pharmacokinetic and biodistribution data and agreed that the study may continue without modifications. The second cohort of patients will start at 60mCi of Lu177 rather than 40mCi previously assumed in the protocol. The second cohort of patients is expected to be enrolled by mid-year 2025 and will include expansion to multiple tumor types including NSCLC, Small-Cell Lung Cancer (SCLC), Triple-negative Breast Cancer (TNBC), Cutaneous Melanoma, head and neck squamous cell carcinoma (HNSCC) and Endometrial Cancer.
There are currently four clinical trial sites actively screening and recruiting patients in Australia.
About 177Lu-RAD204:
RAD204 is a single-domain monoclonal antibody (sdAb) that targets PD-L1, a protein that helps control the immune system and is overexpressed in many solid cancers, making it an attractive therapeutic target in multiple tumor types, including NSCLC, SCLC, TNBC, Cutaneous Melanoma, HNSCC, and Endometrial Cancer. Previously published Phase I imaging data of 16 NSCLC patients with 99Tc-RAD204 demonstrated that the diagnostic compound is safe and is associated with acceptable dosimetry2.
Tumor targeting with radioimmunotherapies such as 177Lu-RAD204 has the potential to address resistance mechanisms to current standard-of-care treatment options.
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/
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1 ClinicalTrials.gov ID: NCT06305962
2 Xing Y, et al. J Nucl Med. 2019 Sep;60(9):1213-1220.
FAQ
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