OncoMatch/Clinical Trials/NCT07197645
Samarium Optimized for Long-lasting Analgesia in Cancerous End-stage Bone Pain
Is NCT07197645 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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 →Frequently asked questions
Is NCT07197645 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior palliative external beam radiation therapy disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify