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Radiopharmaceutical

CycloSam® for Bone Cancer

Phase 1
Recruiting
Research Sponsored by QSAM Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 38, 42, 68, 4 months, 6 months, 8 months, 12 months, 24 months, and 36 months
Awards & highlights
No Placebo-Only Group

Summary

This trial tests the safety and how much CycloSam® can be safely given as two doses to treat bone tumors.

Who is the study for?
This trial is for people aged 15-75 with bone cancer or tumors that have spread to the bones, visible on a bone scan. They must have tried other treatments without cure and be in stable condition with good organ function. Contraception is required during and after treatment.
What is being tested?
The study tests different doses of CycloSam® (Samarium-153-DOTMP), a drug that targets radiation to bones, to find the highest dose patients can tolerate without severe side effects. Participants receive two rounds of this radiopharmaceutical therapy.
What are the potential side effects?
Potential side effects include temporary low calcium levels which might cause muscle cramps or tingling sensations. Since it's radiation-based, there may also be risks similar to those associated with other forms of radiation therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 38, 42, 68, 4 months, 6 months, 8 months, 12 months, 24 months, and 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 38, 42, 68, 4 months, 6 months, 8 months, 12 months, 24 months, and 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Dose Limiting Toxicity Rate (DLT)
Secondary study objectives
Bone Tumor Efficacy - Clinical Response Rate
Overall Survival
Pain Palliation
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Dose Level 4Experimental Treatment1 Intervention
Everyone gets a first dose of 0.5 mCi/kg dose and then in 7 days a second dose of 3.0 mCi/kg
Group II: Dose Level 3Experimental Treatment1 Intervention
Everyone gets a first dose of 0.5 mCi/kg dose and then in 7 days a second dose of 2.0 mCi/kg
Group III: Dose Level 2Experimental Treatment1 Intervention
Everyone gets a first dose of 0.5 mCi/kg dose and then in 7 days a second dose of 1.0 mCi/kg
Group IV: Dose Level 1Experimental Treatment1 Intervention
Everyone gets a first dose of 0.5 mCi/kg dose and then in 7 days a second dose of 0.5 mCi/kg

Find a Location

Who is running the clinical trial?

QSAM Therapeutics, Inc.Lead Sponsor
Barry SugarmanStudy DirectorQSAM Therapeutics, Inc.
~5 spots leftby Nov 2025
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