Viewing Study NCT06008483



Ignite Creation Date: 2024-05-06 @ 7:25 PM
Last Modification Date: 2024-10-26 @ 3:06 PM
Study NCT ID: NCT06008483
Status: RECRUITING
Last Update Posted: 2023-08-23
First Post: 2023-08-04

Brief Title: A Dose Finding Study to Treat Bone Tumors
Sponsor: QSAM Therapeutics Inc
Organization: QSAM Therapeutics Inc

Study Overview

Official Title: A Dose Finding Study of CycloSam 153-Sm-DOTMP to Treat Solid Tumors in the Bone or Metastatic to the Bone Metastatic Prostate Breast and Lung Osteosarcoma Ewings Sarcoma and Other Solid Tumors to the Bone All Eligible
Status: RECRUITING
Status Verified Date: 2023-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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 tumors in the bone or metastatic solid tumors to the bone that are visible on bone scan
Detailed Description: This is an open-label unblinded multi-center dose-finding study of 153-Sm-DOTMP CycloSam a radiopharmaceutical that delivers radiation to the bone when injected to identify the MTD of 153-Sm- DOTMP given as a tandemly administered pair of doses to subjects with solid tumors visible on bone scan The MTD will be defined as the dose level that produces a dose limiting toxicity DLT rate no greater than 25 DLTs will be defined as any grade 3 or greater hematologic or nonhematologic toxicity as defined by the National Cancer Institute NCI - Common Terminology Criteria for Adverse Events CTCAE experienced during a 42 day observation window Clinical response will be defined as either stable disease SD or a decrease in the size of the tumor by radiographic imaging which may include computed tomography CT or magnetic resonance imaging MRI using Response Evaluation Criteria in Solid Tumors RECIST v11The Day 1 dose will remain constant at 05 mCikg with the Day 8 dose escalated from 05 mCikg dose level 1 to 10 mCikg dose level 2 to 20 mCikg dose level 3 and then to 30 mCikg dose level 4

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None