177Lu-BetaBart in Patients With Relapsed/Refractory, Locally Advanced Inoperable, or Metastatic Solid Tumors
← catalyst calendarNCT07189871 · readout ≤ 498 d
Sponsored by Radiopharm Theranostics, Ltd (industry) · RADX — their whole pipeline →. With Medpace, Inc..
Phase
Phase 1/2
Status
Recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
61estimated
Sites
4
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-02-23 | actual | When the study began enrolling |
| Primary completion | Dec 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Dec 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2025-09-24 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-03-27 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
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 )
- Head &Amp; Neck Squamous Cell Carcinoma (HNSCC)
- Esophageal Squamous Cell Carcinoma (ESCC)
Intervention
- Drug: 177Lu-BetaBart — also filed as RV-01, B335 177Lu-DOTA-anti-B7-H3
Primary outcomes
what the primary-completion date above is the date OFRecommended dose(s) of 177Lu-BetaBart for future exploration (phase 1)
measured 6 weeks
Incidence of treatment emergent adverse events of 177-Lu-BetaBart (phase 1) (Safety and Tolerability)
measured 6 weeks
To assess the preliminary anti-tumor activity of 177Lu-BetaBart at the RP2D (phase 2a)
measured Up to 30 weeks
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)
measured Up to 30 weeks
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