Status:
UNKNOWN
A Dose Finding Study to Treat Bone Tumor(s)
Lead Sponsor:
QSAM Therapeutics, Inc.
Conditions:
Bone Cancer
Bone Tumor
Eligibility:
All Genders
15-75 years
Phase:
PHASE1
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...
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- ...
Eligibility Criteria
Inclusion
- Subjects will be between the ages of 15 and 75, inclusive.
- Subjects must have a histologically confirmed diagnosis of a solid tumor metastatic to bone, or a histologically confirmed diagnosis of a solid tumor to the bone or metastatic to the bone.
- Subjects must have measurable disease on anatomic imaging that is also avid for phosphonate compounds as demonstrated by a positive 99mTc diphosphonate bone scan. Not all lesions must be positive on bone scan.
- Adequate organ function, including:
- i. Adequate renal function, defined as a measured creatinine clearance \>70 mL/min/1.73 m2 or normal radioisotope glomerular filtration rate (GFR).
- ii. Adequate hematologic function, defined as a platelet count \>100,000 cells/mm3 and an absolute neutrophil count (ANC) \>1,000 cells/mm3.
- Life expectancy of at least eight weeks.
- Karnofsky performance status \>50%.
- Subjects must have adequately recovered from the effects of any prior chemotherapy, as determined by the treating physician and study team, based in part on organ function defined above. Toxicities from previous therapies must have recovered to CTCAE v5.0 grade ≤1. Subjects with Grade 2 anemia per CTCAE v5.0 will be permitted as long as the subject has normal cardiac function.
- Adequate cardiac function. Subjects with previously identified cardiac disease will be eligible, as 153Sm-DOTMP is not expected to cause cardiac dysfunction and is only expected to result in very transient hypocalcemia.
- A stem cell product collected either by peripheral stem cell mobilization or bone marrow harvest prior to the infusion of CycloSam® must be available, prior to trial entry. A minimum of 2 x 106 CD34+ cells/kg ideal body weight are required.
- Female subjects of child-bearing potential (defined as premenopausal and capable of becoming pregnant) must have a negative serum pregnancy test at the Screening visit. Females must be surgically sterile, postmenopausal for at least one year prior to Screening (no other medical cause involved) with a Follicle Stimulating Hormone (FSH) level of greater than 40 mIU/mL or must be using a highly effective method of birth control and agree to its use for at least 30 days following the last dose of 153Sm-DOTMP. Highly effective methods of contraceptive are defined as tubal ligation or an approved hormonal contraceptive such as oral contraceptives, patches, implants, injections, rings, or hormonally-impregnated intrauterine device.
- Male subjects with partners of child-bearing potential must agree to use highly effective methods of contraception for at least 90 days after the last dose of 153Sm-DOTMP.
- The subject and/or the subject's legally authorized guardian, if the subject is a minor, must acknowledge in writing that informed consent to become a study subject has been obtained, in accordance with institutional policies approved by the U.S. Department of Health and Human Services.
- Subjects must have previously received effective treatment for their underlying disease and have no potentially curative options available.
- The concurrent use of hormonal therapies or bisphosphonates is acceptable, provided the latter do not render target lesions invisible on 99mTc bone scan. Subjects will have the option to re-screen up to once more after seven days if they do not initially meet all of the inclusion criteria
Exclusion
- Subject is pregnant or breastfeeding.
- Subject is sexually active and does not agree to use accepted, effective forms of contraceptive.
- Subject has received prior radiotherapy to all known areas of current active disease.
- Subject has a body mass index (BMI) \> 50 kg/m2.
Key Trial Info
Start Date :
April 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2024
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT06008483
Start Date
April 5 2022
End Date
November 1 2024
Last Update
August 23 2023
Active Locations (4)
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1
Clinical Trial Site
Chicago, Illinois, United States, 60616
2
Clinical Trial Site
Columbia, Missouri, United States, 65212
3
Clinical Trial Site
New Brunswick, New Jersey, United States, 08901
4
Clinical Trial Site
Houston, Texas, United States, 77024