- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06008483
A Dose Finding Study to Treat Bone Tumor(s)
August 18, 2023 updated by: QSAM Therapeutics, Inc.
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)
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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) v1.1.The Day 1 dose will remain constant at 0.5 mCi/kg, with the Day 8 dose escalated from 0.5 mCi/kg (dose level 1) to 1.0 mCi/kg (dose level 2) to 2.0 mCi/kg (dose level 3) and then to 3.0 mCi/kg (dose level 4).
Study Type
Interventional
Enrollment (Estimated)
17
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Clinical Trials Team
- Phone Number: 512-343-4558
- Email: clinicaltrials@qsambio.com
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60616
- Recruiting
- Clinical Trial Site
-
-
Missouri
-
Columbia, Missouri, United States, 65212
- Active, not recruiting
- Clinical Trial Site
-
-
New Jersey
-
New Brunswick, New Jersey, United States, 08901
- Recruiting
- Clinical Trial Site
-
-
Texas
-
Houston, Texas, United States, 77024
- Recruiting
- Clinical Trial Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Dose Level 1
Everyone gets a first dose of 0.5 mCi/kg dose and then in 7 days a second dose of 0.5 mCi/kg
|
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.
|
Other: Dose Level 2
Everyone gets a first dose of 0.5 mCi/kg dose and then in 7 days a second dose of 1.0 mCi/kg
|
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.
|
Other: Dose Level 3
Everyone gets a first dose of 0.5 mCi/kg dose and then in 7 days a second dose of 2.0 mCi/kg
|
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.
|
Other: Dose Level 4
Everyone gets a first dose of 0.5 mCi/kg dose and then in 7 days a second dose of 3.0 mCi/kg
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dose Limiting Toxicity Rate (DLT)
Time Frame: 42 Days
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bone Tumor Efficacy - Clinical Response Rate
Time Frame: Day 42, 68, 4 months, 8 months, 12 months, 24 months, and 36 months
|
Clinical response rate - defined as either SD or a decrease in the size of the tumor by radiographic imaging (which may include CT or MRI) using RECIST v1.1 criteria with the tumor measured in mm by days and months.
|
Day 42, 68, 4 months, 8 months, 12 months, 24 months, and 36 months
|
Overall Survival
Time Frame: Day 38, 42, 68, 4 months, 6 months, 8 months, 12 months, 24 months, and 36 months
|
Overall survival - defined as the time from start of treatment to death due to any cause as measured in days and months
|
Day 38, 42, 68, 4 months, 6 months, 8 months, 12 months, 24 months, and 36 months
|
Time to Progression
Time Frame: Day 42, 68, 4 months, 8 months, 12 months, 24 months, and 36 months
|
Time to progression - defined as the time from start of treatment to appearance of new lesions or expansion of current lesions by 20% as per RECIST v1.1 criteria in mm of tumor and by days and months
|
Day 42, 68, 4 months, 8 months, 12 months, 24 months, and 36 months
|
Pain Palliation
Time Frame: Day 38, 42, 68, 4 months, 6 months, 8 months, 12 months, 24 months, and 36 months
|
Pain palliation as assessed per the pain VAS as measured in mm of length of a 100 mm Visual Analog Pain Scale by days and months
|
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
Time Frame: Day 38, 42, 68, 4 months, 6 months, 8 months, 12 months, 24 months, and 36 months
|
Safety based on the number of Treatment Emergent Adverse event (TEAEs), as measured by the number of these events by days and months.
|
Day 38, 42, 68, 4 months, 6 months, 8 months, 12 months, 24 months, and 36 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Barry Sugarman, QSAM Therapeutics, Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 5, 2022
Primary Completion (Estimated)
April 5, 2024
Study Completion (Estimated)
November 1, 2024
Study Registration Dates
First Submitted
August 4, 2023
First Submitted That Met QC Criteria
August 18, 2023
First Posted (Actual)
August 23, 2023
Study Record Updates
Last Update Posted (Actual)
August 23, 2023
Last Update Submitted That Met QC Criteria
August 18, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- QSAM-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bone Cancer
-
St. Jude Children's Research HospitalTerminatedLimb Salvage | Cancer of the BoneUnited States
-
University of Roma La SapienzaCompletedBone Metastases | Secondary Bone CancerItaly
-
Yale UniversityNational Cancer Institute (NCI)Completed
-
Iva HauptmannovaAdler OrthoRecruiting
-
Dana-Farber Cancer InstituteRecruitingBone Mineral Density | Childhood Cancer SurvivorsUnited States
-
University of CopenhagenThe Novo Nordic FoundationUnknownPain | Metastatic Breast Cancer | Bone MetastasesDenmark
-
Stanford UniversityTerminated
-
University of FloridaCompleted
-
Beth Israel Deaconess Medical CenterUnknown
Clinical Trials on 153-Sm-DOTMP (Samarium-153-DOTMP)
-
Radiation Therapy Oncology GroupNational Cancer Institute (NCI); NRG OncologyCompleted
-
OncotherapeuticsCompletedMultiple Myeloma and Plasma Cell NeoplasmUnited States
-
Mayo ClinicNational Cancer Institute (NCI)CompletedMultiple Myeloma and Plasma Cell NeoplasmUnited States
-
M.D. Anderson Cancer CenterCytogen CorporationCompletedBreast Cancer | Bone MetastasesUnited States
-
Cytogen CorporationUnknownProstatic NeoplasmsUnited States
-
Mayo ClinicNational Cancer Institute (NCI)CompletedPain | Multiple Myeloma and Plasma Cell NeoplasmUnited States
-
National Cancer Institute (NCI)CompletedProstate CancerUnited States
-
Radiation Therapy Oncology GroupNational Cancer Institute (NCI); NRG OncologyCompletedPain | Breast Cancer | Lung Cancer | Prostate Cancer | Metastatic CancerUnited States
-
Sidney Kimmel Comprehensive Cancer Center at Johns...National Cancer Institute (NCI); Jazz PharmaceuticalsTerminatedMetastatic OsteosarcomaUnited States
-
Sidney Kimmel Comprehensive Cancer Center at Johns...Sanofi; Cytogen CorporationCompletedProstate CancerUnited States