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177Lu-BetaBart in Patients With Relapsed/Refractory, Locally Advanced Inoperable, or Metastatic Solid Tumors

Study acronym: BetaBart
StatusRecruiting
PhasePhase 1/2
Started2026-02-23
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint removed 4 → 3 primary endpoints
See other at-risk trials from Radiopharm Theranostics, Ltd

Amendment history

2026-10-01
Primary endpoint(s) modified4 to 3 entries
WasIncidence of treatment emergent adverse events of 177-Lu-BetaBart (phase 1) (Safety and Tolerability), Recommended dose(s) of 177Lu-BetaBart for future exploration (phase 1), To assess preliminary anti-tumor activity, as defined by biochemical response, in CRPC participants who are treated with 177Lu-BetaBart at the RP2D (phase 2a), To assess the preliminary anti-tumor activity of 177Lu-BetaBart at the RP2D (phase 2a)
NowSafety and Tolerability of 177LuBetaBart, To assess preliminary anti-tumor activity, as defined by biochemical response, in CRPC participants at the RP2D, To assess the preliminary anti-tumor activity of 177Lu-BetaBart at the RP2D
Interventions modified
2026-03-24
Study Status, Contacts/Locations v2
Start dateestimated 2026-02→confirmed 2026-02-23
Study sites2→4
2026-01-13
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start date2025-11→2026-02
Study sites0→2
2025-09-19
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 10 more diseases
This is a Phase 1/2a dose escalation and expansion study to determine the safety, tolerability, and preliminary clinical activity of 177LuBetaBart, a lutetium-labeled anti-B7-H3 monoclonal antibody, in patients with relapsed/refractory, locally advanced inoperable, or metastatic solid tumors
Trial Details
NCT Number NCT07189871
Lead Sponsor Radiopharm Theranostics, Ltd
Collaborators: Medpace, Inc.
Conditions Castration-Resistant Prostate Cancer (CRPC), Colorectal Cancer, NSCLC (Non-small Cell Lung Cancer), Ovarian Cancer, Cervical Cancer, Endometrial Cancer, TNBC, Triple Negative Breast Cancer, Small Cell Lung Cancer (SCLC ) +3 more
Enrollment 61 participants
Start Date 2026-02-23
Primary Completion 2027-12 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-10-01