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177Lu-anti-PD-L1 sdAb in Metastatic Solid Tumors

StatusRecruiting
PhaseEarly Phase 1
Started2024-06-03
View on ClinicalTrials.gov ↗

Amendment history

2026-02-17
Study Status, Contacts/Locations v10
Study sitescontacts updated at 1 of 5 sites
2026-02-08
Study Status, Study Description, Conditions, Study Design, Outcome Measures, Eligibility, Contacts/Locations v9
Primary completion date2025-07→2027-12
Completion date2025-10→2027-12
Enrollment target23→30
Study sites6→5
Eligibility criteria+674 characters
[...] s with a documented history of histopathologically confirmed relapsed/refractory locally advanced, inoperable or metastatic NSCLC, SCLC, TNBC, cutaneous melanoma, HNSCC, and endometrial cancer or any cancer that is known to be MMR deficient or MSI high with documented disease progression during or after their m [...] d standard of care therapy (including PD-1/PD-L1 inhibitors), or have refused or have no standard of care therapy available that is likel [...] D-L1 positive NSCLC, SCLC, TNBC, cutaneous melanoma, HNSCC, and endometrial cancer or any cancer that is known to be MMR deficient or MSI high: If the [...] [...]
Study description+1,335 characters
This is a first in human, Phase 0/1, open-label study of 177Lu-RAD204 consisting of an Imaging Period with 177Lu-RAD204im (imaging dose) and a Treatment Period with 177Lu-RAD204tr (treatment dose) to determine the recommended dose(s) for future exploration of 177Lu-RAD204 in participants with PDL1+ [...]
2025-04-29
Study Identification, Study Status, Contacts/Locations v8
Study sitesdetails revised at 1 of 6 sites
Study titlerevised
177Lu-anti-PD-L1 SdAbsdAb in Metastatic Solid Tumors
2025-03-24
Study Status v7
Re-verified, no change to tracked fields
2025-03-16
Study Status, Study Description, Conditions, Eligibility, Contacts/Locations v6
Study sites4→6
Eligibility criteria-895 characters
[...] 18 years of age. Participants with a documented history of histopathologicalhistopathologically confirmed metastatic NSCLC, SCLC, TNBC, cutaneous melanoma, HNSCC, and endometrial cancer with documented disease progression during or after their most recent line of anticancer therapy. Participants must be refractory to or have refused standard of care therapy (including PD-1/PD-L1 inhibitors), or have no standard of care [...] that is unresectable,likely progressiveto andprovide forclinical which standard treatment measures are no longer effectivebenefit. Participants with a documented history of PD- [...] [...]
Show 5 earlier versions
2025-03-05
Study Status, Contacts/Locations v5
Study sitesdetails revised at 1 of 4 sites
2024-12-12
Study Identification, Study Status, Contacts/Locations v4
Study sites4 entries, revised
HollywoodGenesisCare Private HospitalMurdoch
Study title-14 characters
177Lu-anti-PD-L1 SdAb in Metastatic Non-smallSolid Cell Lung CancerTumors
2024-10-17
Study Identification, Study Status, Contacts/Locations v3
Start dateestimated 2024-06→confirmed 2024-06-03
Study sites3→4
Study titlerevised
177Lu-anti-PD-L1 sdAbSdAb in Metastatic Non-small Cell Lung Cancer
2024-05-21
Study Status, Arms and Interventions, Contacts/Locations v2
Start date2024-03→2024-06
Study sites2→3
Study arms0→1
2024-03-23
Study Status, Contacts/Locations v1
Study sites1→2
2024-03-07
Original filing
Radiopharm Theranostics, Ltd
7 trials monitored
See 3 trials at risk
Breast Cancer
5,180 trials monitored
See 256 trials at risk
Lung Cancer
4,033 trials monitored
See 210 trials at risk
Non-Small Cell Lung Cancer (NSCLC)
2,914 trials monitored
See 156 trials at risk
and 5 more diseases
This is a Phase 0/1, First-in-Human (FIH), study to evaluate safety, tolerability, biodistribution, radiation dosimetry and preliminary anti-tumour activities of 177Lu-RAD204 in participants with selected solid tumours, to identify the MTDs/ recommended doses of 177Lu-RAD204 for future exploration. The study will consist of a Pre-screening Period (if applicable for PD-L1 testing), a Screening Period of up to 4 weeks, followed by a Phase 0 (Imaging) Period for imaging and dosimetry to 177Lu-RAD204im and a Phase I (Treatment) Period for 177Lu-RAD204tr dose escalation.
Trial Details
NCT Number NCT06305962
Lead Sponsor Radiopharm Theranostics, Ltd
Conditions PDL1 Gene Mutation, Non Small Cell Lung Cancer, Small Cell Lung Cancer ( SCLC ), TNBC, Triple Negative Breast Cancer, Cutaneous Melanoma, HNSCC, Endometrial Cancer, Mmr Deficiency +1 more
Enrollment 30 participants
Start Date 2024-06-03
Primary Completion 2027-12 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-02-19