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A Dose Finding Study to Treat Bone Tumor(s)

NCT06008483 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2023-08-23

No results posted yet for this study

Summary

To determine the Maximum Tolerated Dose (MTD) of CycloSam®, Samarium-153-DOTMP (Sm-153-DOTMP), a radiopharmaceutical that delivers radiation to the bone when injected, given as a tandemly administered pair of doses to subjects with one or more solid tumor(s) in the bone or metastatic solid tumors to the bone that are visible on bone scan.

Conditions

  • Bone Cancer
  • Bone Tumor
  • Solid Tumor
  • Metastatic Cancer to the Bone
  • Metastatic Tumor to the Bone

Interventions

DRUG

153-Sm-DOTMP (Samarium-153-DOTMP)

This is an open-label, unblinded, multi-center, dose-finding study of 153Sm-DOTMP (CycloSam®) to identify the MTD of 153Sm- DOTMP, given as a tandemly administered pair of doses to subjects with solid tumors visible on bone scan.

Sponsors & Collaborators

  • QSAM Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Barry Sugarman · QSAM Therapeutics, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
15 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-05
Primary Completion
2024-04-05
Completion
2024-11-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06008483 on ClinicalTrials.gov