Finding the best dose of a new treatment for bone tumors

A Dose Finding Study of CycloSam® (153-Sm-DOTMP) to Treat Solid Tumor(s) in the Bone or Metastatic to the Bone (Metastatic Prostate, Breast, and Lung, Osteosarcoma, Ewing's Sarcoma, and Other Solid Tumor(s) to the Bone All Eligible)

This study is testing the best dose of a new treatment called CycloSam® for people with bone tumors to see how much can be given safely while still helping to shrink the tumors.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (estimated)
• Ages: 15 Years to 75 Years
• Sex: All
• Sponsor: QSAM Therapeutics, Inc. (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 4 sites (Chicago, Illinois and 3 other locations)
• Trial ID: NCT06008483 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to determine the Maximum Tolerated Dose (MTD) of CycloSam®, a radiopharmaceutical that delivers targeted radiation to bone tumors. It is an open-label, multi-center study where participants with solid tumors in the bone will receive tandem doses of the treatment. The study will assess the safety and efficacy of different dose levels, monitoring for any dose-limiting toxicities and evaluating clinical responses through imaging techniques. The goal is to identify the optimal dose that minimizes side effects while effectively treating the tumors.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 15 to 75 with histologically confirmed solid tumors metastatic to the bone that are visible on bone scans.

Not a fit: Patients with non-solid tumors or those who do not meet the eligibility criteria, such as inadequate organ function or poor performance status, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new targeted therapy option for patients with bone tumors, potentially improving their outcomes.

How similar studies have performed: While this approach is novel in its specific application, similar studies using radiopharmaceuticals for bone tumors have shown promise in the past.

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.

Where this trial is running

Chicago, Illinois and 3 other locations

• Clinical Trial Site — Chicago, Illinois, United States (Recruiting)
• Clinical Trial Site — Columbia, Missouri, United States (Active_not_recruiting)
• Clinical Trial Site — New Brunswick, New Jersey, United States (Recruiting)
• Clinical Trial Site — Houston, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Clinical Trials Team

Conditions Bone Cancer; Bone Tumor; Solid Tumor; Metastatic Cancer to the Bone; Metastatic Tumor to the Bone; Bone cancer