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A Dose Finding Study to Treat Bone Tumor(s)

Primary Purpose

Bone Cancer, Bone Tumor, Solid Tumor

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
153-Sm-DOTMP (Samarium-153-DOTMP)
Sponsored by
QSAM Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Cancer focused on measuring Bone cancer, Bone Tumor, Solid Tumor, Metastatic Cancer to the Bone, Metastatic Tumor to the Bone

Eligibility Criteria

15 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clinical Trial SiteRecruiting
  • Clinical Trial Site
  • Clinical Trial SiteRecruiting
  • Clinical Trial SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Dose Level 1

Dose Level 2

Dose Level 3

Dose Level 4

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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%.

Secondary Outcome Measures

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.
Overall Survival
Overall survival - defined as the time from start of treatment to death due to any cause as measured in days and 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
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
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.

Full Information

First Posted
August 4, 2023
Last Updated
August 18, 2023
Sponsor
QSAM Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT06008483
Brief Title
A Dose Finding Study to Treat Bone Tumor(s)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 5, 2022 (Actual)
Primary Completion Date
April 5, 2024 (Anticipated)
Study Completion Date
November 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
QSAM Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Masking Description
This clinical trial is unblinded, non-randomized, and there is no placebo group. All participants receive active drug product.
Allocation
Non-Randomized
Enrollment
17 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dose Level 1
Arm Type
Other
Arm Description
Everyone gets a first dose of 0.5 mCi/kg dose and then in 7 days a second dose of 0.5 mCi/kg
Arm Title
Dose Level 2
Arm Type
Other
Arm Description
Everyone gets a first dose of 0.5 mCi/kg dose and then in 7 days a second dose of 1.0 mCi/kg
Arm Title
Dose Level 3
Arm Type
Other
Arm Description
Everyone gets a first dose of 0.5 mCi/kg dose and then in 7 days a second dose of 2.0 mCi/kg
Arm Title
Dose Level 4
Arm Type
Other
Arm Description
Everyone gets a first dose of 0.5 mCi/kg dose and then in 7 days a second dose of 3.0 mCi/kg
Intervention Type
Drug
Intervention Name(s)
153-Sm-DOTMP (Samarium-153-DOTMP)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Dose Limiting Toxicity Rate (DLT)
Description
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%.
Time Frame
42 Days
Secondary Outcome Measure Information:
Title
Bone Tumor Efficacy - Clinical Response Rate
Description
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.
Time Frame
Day 42, 68, 4 months, 8 months, 12 months, 24 months, and 36 months
Title
Overall Survival
Description
Overall survival - defined as the time from start of treatment to death due to any cause as measured in days and months
Time Frame
Day 38, 42, 68, 4 months, 6 months, 8 months, 12 months, 24 months, and 36 months
Title
Time to Progression
Description
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
Time Frame
Day 42, 68, 4 months, 8 months, 12 months, 24 months, and 36 months
Title
Pain Palliation
Description
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
Time Frame
Day 38, 42, 68, 4 months, 6 months, 8 months, 12 months, 24 months, and 36 months
Title
Safety Based on Number of Treatment Emergent Adverse Events
Description
Safety based on the number of Treatment Emergent Adverse event (TEAEs), as measured by the number of these events by days and months.
Time Frame
Day 38, 42, 68, 4 months, 6 months, 8 months, 12 months, 24 months, and 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trials Team
Phone
512-343-4558
Email
clinicaltrials@qsambio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barry Sugarman
Organizational Affiliation
QSAM Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Trial Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Clinical Trial Site
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Links:
URL
http://www.qsambio.com
Description
Sponsor Website, Public Company Symbol QSAM

Learn more about this trial

A Dose Finding Study to Treat Bone Tumor(s)

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