Trials / Not Yet Recruiting

Not Yet RecruitingNCT06982222

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

A First-in-Human Dose-Finding Phase I Study of Bone-targeted High Specific Activity Stannic-117m Pentatate (Sn-117m-DTPA) in Solid Tumors With Skeletal Metastases

Status: Not Yet Recruiting
Phase: Phase 1
Study type: Interventional
Enrollment: 24 (estimated)

Sponsor: National Cancer Institute (NCI) · NIH
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVE: I. To assess the safety and tolerability of tin Sn 117m pentetate (Sn-117m- diethylenetriaminepentaacetic acid \[DTPA\]) per Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. SECONDARY OBJECTIVES: I. To observe and record anti-tumor activity by prostate-specific membrane antigen (PSMA) positron emission tomography (PET) response criteria for prostate cancer and Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST) response criteria for breast and non-small cell lung cancers. II. To evaluate time to the first symptomatic skeletal event defined as (i) the first use of external-beam radiation therapy to relieve skeletal symptoms; (ii) new symptomatic pathologic vertebral or nonvertebral bone fractures; (iii) spinal cord compression; or (iv) tumor-related orthopedic surgical intervention (Scher et al., 2016). III. To measure changes and time to progression in serum prostate-specific antigen (PSA) (in prostate cancer patients only), and bone-specific alkaline phosphatase (bALK PHOS) (in all patients). IV. To evaluate 2-year progression-free survival (PFS) and overall survival (OS) rates. V. To characterize the biodistribution and dosimetry of high specific activity Sn-117m-DTPA in the treated population. OUTLINE: This is a dose-escalation study followed by a dose-expansion study. Patients receive Sn-117m-DTPA intravenously (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/computed tomography (CT) and single photon emission computed tomography (SPECT)/CT throughout the study. Additionally, prostate cancer patients undergo technetium TC-99m (Tc-99m) bone scan at baseline and PSMA PET/CT throughout the study. After completion of study treatment, patients are followed up every 6 months until death.

Conditions

Interventions

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

Timeline

Start date: 2026-10-01
Primary completion: 2027-02-12
Completion: 2027-02-12
First posted: 2025-05-21
Last updated: 2026-04-13

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT06982222. Inclusion in this directory is not an endorsement.