A Dose Finding Study to Treat Bone Tumor(s)

Launched by QSAM THERAPEUTICS, INC. · Aug 18, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called CycloSam®, which is a special type of medicine that delivers radiation directly to bone tumors. The goal of the study is to find out the highest safe dose of this treatment for patients with bone cancer, including those with tumors that have spread to the bones from other parts of the body. The trial is currently enrolling participants aged 15 to 75 who have confirmed bone tumors that can be seen on a specific imaging test.

To be eligible for the study, participants must have a confirmed diagnosis of a solid tumor that has spread to the bone, have measurable disease, and have enough healthy organ function. They should also have already received other treatments for their cancer and have no other curative options available. Participants can expect to receive the treatment and be monitored for its effects. It’s important to note that women who can become pregnant and men with partners of child-bearing age will need to use effective birth control during and after the study. If you or someone you know is interested in participating, it’s essential to discuss this with a healthcare provider for more information.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subjects will be between the ages of 15 and 75, inclusive.
• • 2. 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.
• • 3. 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.
• 4. 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.
• • 5. Life expectancy of at least eight weeks.
• • 6. Karnofsky performance status \>50%.
• • 7. 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.
• • 8. 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.
• • 9. 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.
• • 10. 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.
• • 11. 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.
• • 12. 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.
• • 13. Subjects must have previously received effective treatment for their underlying disease and have no potentially curative options available.
• • 14. 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 Criteria:
• • 1. Subject is pregnant or breastfeeding.
• • 2. Subject is sexually active and does not agree to use accepted, effective forms of contraceptive.
• • 3. Subject has received prior radiotherapy to all known areas of current active disease.
• • 4. Subject has a body mass index (BMI) \> 50 kg/m2.