Bone CancerPhase 1NCT06008483
A Dose Finding Study to Treat Bone Tumor(s)
A Phase 1 study testing 153-Sm-DOTMP (Samarium-153-DOTMP) in people with Bone Cancer and Bone Tumor, run by QSAM Therapeutics, Inc. at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 75 years
- Conditions the study is for
- Bone Cancer, Bone Tumor, Solid Tumor
- What is being tested?
- 153-Sm-DOTMP (Samarium-153-DOTMP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 4 sitesUnited States
- Study dates
- 5 Apr 2022to 8 Aug 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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:
- Adequate renal function, defined as a measured creatinine clearance >70 mL/min/1.73 m2 or normal radioisotope glomerular filtration rate (GFR).
- Adequate hematologic function, defined as a platelet count >100,000 cells/mm3 and an absolute neutrophil count (ANC) >1,000 cells/mm3.
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- 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
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Clinical Trial Site
Chicago, Illinois, 60616
Clinical Trial Site
Columbia, Missouri, 65212
Clinical Trial Site
Houston, Texas, 77024
Clinical Trial Site
New Brunswick, New Jersey, 08901
About this study
Official title: 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.
Read the 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).
- Conditions
- Bone Cancer, Bone Tumor, Solid Tumor, Metastatic Cancer to the Bone, Metastatic Tumor to the Bone
- Being tested
- 153-Sm-DOTMP (Samarium-153-DOTMP)
- Keywords
- Bone cancer, Bone Tumor, Solid Tumor, Metastatic Cancer to the Bone, Metastatic Tumor to the Bone
- Medical subject headings
- Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: 153-Sm-DOTMP (Samarium-153-DOTMP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 42 Days
Secondary outcomes (5)
Bone Tumor Efficacy - Clinical Response Rate
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.
Measured: Day 42, 68, 4 months, 8 months, 12 months, 24 months, and 36 months
Overall Survival
Overall survival - defined as the time from start of treatment to death due to any cause as measured in days and months
Measured: Day 38, 42, 68, 4 months, 6 months, 8 months, 12 months, 24 months, and 36 months
Time to Progression
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
Measured: Day 42, 68, 4 months, 8 months, 12 months, 24 months, and 36 months
Pain Palliation
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
Measured: 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
Safety based on the number of Treatment Emergent Adverse event (TEAEs), as measured by the number of these events by days and months.
Measured: Day 38, 42, 68, 4 months, 6 months, 8 months, 12 months, 24 months, and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start5 Apr 2022
- Primary completion8 Aug 2024
- Study completion8 Aug 2024
Why it stopped: Change in development program indication
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- QSAM Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barry Sugarman, Study director, QSAM Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06008483
- Sponsor's protocol ID
- QSAM-001
- Status last verified
- Jul 2026
- First submitted
- 4 Aug 2023
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06008483
- Acronym / sponsor ID
- QSAM-001
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change in development program indication
- Enrolment
- 5 participants (actual)
- Lead sponsor
- QSAM Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Apr 2022 (actual)
- Primary completion
- 8 Aug 2024 (actual)
- Study completion
- 8 Aug 2024 (actual)
- First posted
- 23 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose Level 1 | Other | Drug: 153-Sm-DOTMP (Samarium-153-DOTMP)Everyone gets a first dose of 0.5 mCi/kg dose and then in 7 days a second dose of 0.5 mCi/kg |
| Dose Level 2 | Other | Drug: 153-Sm-DOTMP (Samarium-153-DOTMP)Everyone gets a first dose of 0.5 mCi/kg dose and then in 7 days a second dose of 1.0 mCi/kg |
| Dose Level 3 | Other | Drug: 153-Sm-DOTMP (Samarium-153-DOTMP)Everyone gets a first dose of 0.5 mCi/kg dose and then in 7 days a second dose of 2.0 mCi/kg |
| Dose Level 4 | Other | Drug: 153-Sm-DOTMP (Samarium-153-DOTMP)Everyone gets a first dose of 0.5 mCi/kg dose and then in 7 days a second dose of 3.0 mCi/kg |
Who may qualify
- Ages
- 15 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- 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:
- Life expectancy of at least eight weeks.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 153-Sm-DOTMP (Samarium-153-DOTMP)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. | Drug | Dose Level 1, Dose Level 2, Dose Level 3, Dose Level 4 |
Primary outcome
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%.
5 secondary outcomes
Bone Tumor Efficacy - Clinical Response Rate
Time frame: 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
Time to Progression
Time frame: 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
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
Results and safety
The study was stopped early (reason given: Change in development program indication). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barry Sugarman study director
QSAM Therapeutics, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 153-Sm-DOTMP (Samarium-153-DOTMP) in people with Bone Cancer and Bone Tumor, run by QSAM Therapeutics, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Change in development program indication). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicity Rate (DLT) (time frame: 42 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.