A Dose Finding Study to Treat Bone Tumor(s)

NCT06008483 | Unknown Phase 1 FDA Drug

• 1 other identifier: QSAM-001
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 4

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 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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Dose Limiting Toxicity Rate (DLT)

  The primary endpoint is defined as the DLT rate observed during a 42-day window following administration of 153-Sm-DOTMP for each dose level. 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. The MTD (Maximum Tolerated Dose) will be defined as the dose level that produces a dose limiting toxicity (DLT) rate no greater than 25%.

  42 Days

Secondary Outcomes (5)

• Bone Tumor Efficacy - Clinical Response Rate

  Day 42, 68, 4 months, 8 months, 12 months, 24 months, and 36 months

• Overall Survival

  Day 38, 42, 68, 4 months, 6 months, 8 months, 12 months, 24 months, and 36 months

• Time to Progression

  Day 42, 68, 4 months, 8 months, 12 months, 24 months, and 36 months

• Pain Palliation

  Day 38, 42, 68, 4 months, 6 months, 8 months, 12 months, 24 months, and 36 months

• Safety Based on Number of Treatment Emergent Adverse Events

  Day 38, 42, 68, 4 months, 6 months, 8 months, 12 months, 24 months, and 36 months

Study Arms (4)

Dose Level 1

OTHER

Everyone gets a first dose of 0.5 mCi/kg dose and then in 7 days a second dose of 0.5 mCi/kg

Drug: 153-Sm-DOTMP (Samarium-153-DOTMP)

Dose Level 2

OTHER

Everyone gets a first dose of 0.5 mCi/kg dose and then in 7 days a second dose of 1.0 mCi/kg

Drug: 153-Sm-DOTMP (Samarium-153-DOTMP)

Dose Level 3

OTHER

Everyone gets a first dose of 0.5 mCi/kg dose and then in 7 days a second dose of 2.0 mCi/kg

Drug: 153-Sm-DOTMP (Samarium-153-DOTMP)

Dose Level 4

OTHER

Everyone gets a first dose of 0.5 mCi/kg dose and then in 7 days a second dose of 3.0 mCi/kg

Drug: 153-Sm-DOTMP (Samarium-153-DOTMP)

Interventions

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

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.

Dose Level 1; Dose Level 2; Dose Level 3; Dose Level 4

Eligibility Criteria

• Age: 15 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• QSAM Therapeutics, Inc.: lead

Study Sites (4)

Clinical Trial Site

Chicago, Illinois, 60616, United States

RECRUITING

Clinical Trial Site

Columbia, Missouri, 65212, United States

ACTIVE NOT RECRUITING

Clinical Trial Site

New Brunswick, New Jersey, 08901, United States

RECRUITING

Clinical Trial Site

Houston, Texas, 77024, United States

RECRUITING

MeSH Terms

Conditions

Bone Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Barry Sugarman

  QSAM Therapeutics, Inc.

  STUDY DIRECTOR

Central Study Contacts

Clinical Trials Team

CONTACT

512-343-4558; clinicaltrials@qsambio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: This clinical trial is unblinded, non-randomized, and there is no placebo group. All participants receive active drug product.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2023
• First Posted: August 23, 2023
• Study Start: April 5, 2022
• Primary Completion: April 5, 2024
• Study Completion: November 1, 2024
• Last Updated: August 23, 2023

Record last verified: 2023-08

Locations

US (4)