OncoMatch/Clinical Trials/NCT07197645
Samarium Optimized for Long-lasting Analgesia in Cancerous End-stage Bone Pain
Is NCT07197645 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies 153Sm-DOTMP for bone pain.
Treatment: 153Sm-DOTMP — This is an open label, 2-part early phase study designed to evaluate the safety, pharmacokinetics, radiation dosimetry, and preliminary efficacy of TLX090-Tx in patients with painful bone metastases.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Disease stage
Metastatic disease required
Performance status
KARNOFSKY 61–100
Karnofsky performance status >60%
Prior therapy
Must have received: anti-cancer treatment
Participants have had disease progression while on anti-cancer treatment
Cannot have received: palliative external beam radiation therapy
Exception: lesions not amenable to palliative EBRT
not eligible for the treatments, or their lesions are not amenable to palliative EBRT
Lab requirements
Blood counts
platelet count >100,000 cells/mm3; ANC >1000 cells/mm3; hemoglobin ≥8 g/dL
Kidney function
measured creatinine clearance (CrCl) ≥30 mL/min as per Cockroft Gault or based on radioisotope GFR
Liver function
Total bilirubin ≤1.5 × ULN; ALT or AST ≤5 × ULN with liver metastases; ALT or AST ≤3 × ULN with Gilbert's Syndrome
Cardiac function
No history of unstable angina (at rest) or new-onset angina within 3 months; no myocardial infarction within 3 months; no uncontrolled cardiac arrhythmias (≥Grade 3 CTCAE v5.0) or any history of ≥Grade 3 arrhythmia; no congestive heart failure ≥NYHA Class 2; no clinically significant ECG abnormalities including QTcF >450 msec (males) or >470 msec (females)
Adequate organ function, including: Renal function, defined as a measured creatinine clearance (CrCl) ≥30 mL/min as per Cockroft Gault or based on radioisotope glomerular filtration rate (GFR). Hematologic function, defined as a platelet count of >100,000 cells/mm3 and an Absolute neutrophil count (ANC) of >1000 cells/mm3. Hemoglobin ≥8 g/dL. Liver function: Total bilirubin ≤1.5 × the upper limit of normal (ULN). Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤5 × ULN with participants with known liver metastases. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤3 × ULN with participants with Gilbert's Syndrome. Cardiac: see exclusion criteria.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Houston Metro Urology · Houston, Texas
- Oncology Consultants · Houston, Texas
- Excel Diagnostics and Nuclear Oncology Center · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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