Testing the Safety of the Anti-cancer Drug, Sn-117m-DTPA, for Advanced Cancers That Have Spread to Bones

Sponsor
National Cancer Institute (NCI)
Study ID
NCT06982222
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Anatomic Stage IV Breast Cancer AJCC v8
  • Metastatic Breast Carcinoma
  • Metastatic Lung Non-Small Cell Carcinoma
  • Metastatic Malignant Neoplasm in the Bone
  • Metastatic Prostate Adenocarcinoma
  • Stage IV Lung Cancer AJCC v8
  • Stage IVB Prostate Cancer AJCC v8

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo urine and blood sample collection
  • Bone Scan — PROCEDURE
    Undergo technetium TC-99m bone scan
  • Computed Tomography — PROCEDURE
    Undergo PET/CT, SPECT/CT and PSMA PET/CT
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT
  • PSMA PET Scan — PROCEDURE
    Undergo PSMA PET/CT
  • Single Photon Emission Computed Tomography — PROCEDURE
    Undergo SPECT/CT
  • Technetium TC-99m — RADIATION
    Undergo technetium TC-99m bone scan
  • Tin Sn 117m Pentetate — RADIATION
    Given IV

Study Details

This phase I trial tests the safety, side effects and best dose of tin (Sn)-177m-diethylenetriaminepentaacetic acid (DTPA) and how well it works in treating prostate, breast or non-small cell lung cancer that has spread from where it first started (primary site) to the bones (bone metastases). Sn-117m-DTPA was originally tested in tumors that had spread to the bones to help reduce bone pain. The drug has been improved and is designed to send low-level radiation to tumors in the bone while being gentler on the bone marrow, where blood cells are made. Sn-117m-DTPA may be safe and tolerable, and may slow down or shrink tumors in patients with metastatic prostate, breast, or non-small cell lung cancer that has spread to the bones.

Key Dates

First listed
May 21, 2025
Start date
Oct 1, 2026
Status verified
Apr 2026
Primary completion
Feb 12, 2027
Completion
Feb 12, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (Sn-117m-DTPA)
    Patients receive Sn-117m-DTPA IV over 10 minutes on day 1 of each cycle. Cycles repeat every 56 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo urine and blood sample collection, PET/CT and SPECT/CT throughout the study. Additionally, prostate cancer patients undergo Tc-99m bone scan at baseline and PSMA PET/CT throughout the study.

Primary Outcome Measure

Frequency of dose-limiting toxicities [ Time Frame: Up to completion of 1 cycle (cycle length = 56 days) ]

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