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153Sm-DOTMP

Phase 1

Bone Pain | Small molecule | Oncology |Telix Pharmaceuticals Limited|Last Updated: May 14, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment33

FDA Designations

No designations recorded

Clinical trial landscape

153Sm-DOTMP · 1 trial · 3 indications

Phase 1 1
NCT07197645Samarium Optimized for Long-lasting Analgesia in Cancerous End-stage Bone PainBone Pain
RECRUITING33 Analytics
PHASE1RECRUITING
Samarium Optimized for Long-lasting Analgesia in Cancerous End-stage Bone Pain
Bone Pain
NCT0719764533
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Study Endpoints

Primary Endpoints

Incidence and severity of treatment-emergent adverse events (TEAEs) [Safety and Tolerability]
Up to 6 weeks post-dose

Incidence and severity of hematologic and non-hematologic toxicities, graded per CTCAE v5.0, assessed through 6 weeks post-dose.

Secondary Endpoints

Change from baseline in patient-reported bone pain severity using the NRS-11 scale on the form
Baseline to 16 weeks post-dose
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeSUPPORTIVE_CARE

Treatment Arms

ArmTypeDescription
Part A - Cohort 1EXPERIMENTALDose Escalation

Interventions

NameTypeDescription
153Sm-DOTMPDRUGTLX090-Tx will be administered as a single ascending intravenous dose to participants with at least 1 confirmed painful osteoblastic bone tumor that exhibits avid uptake as shown by 99mTcdiphosphonate bone scans undertaken within 60 days of dosing.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Participants have had disease progression while on anti-cancer treatment, and are not eligible for the treatments, or their lesions are not amenable to palliative EBRT. * Participants must have a histologically confirmed diagnosis of malignancy at any time prior to their parti...

Countries:United States
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Frequently asked questions about 153Sm-DOTMP

What is 153Sm-DOTMP used for?

153Sm-DOTMP is an investigational small molecule being developed for the treatment of bone pain, specifically in patients with metastatic bone tumors or bone metastases from advanced cancer. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who is developing 153Sm-DOTMP?

153Sm-DOTMP is being developed by Telix Pharmaceuticals Limited, a biopharmaceutical company listed on the Australian Securities Exchange under the ticker TLX. The company is conducting clinical trials for this investigational drug in the United States.

What phase is 153Sm-DOTMP in?

153Sm-DOTMP is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory agencies and is still undergoing clinical trials to evaluate its safety and efficacy in patients with bone pain from metastatic cancer.

What clinical trials is 153Sm-DOTMP in?

153Sm-DOTMP is being studied in a Phase 1 clinical trial registered as NCT07197645, titled 'Samarium Optimized for Long-lasting Analgesia in Cancerous End-stage Bone Pain.' This trial is currently recruiting participants in the United States and aims to enroll 33 patients with bone pain from metastatic bone tumors.

How does 153Sm-DOTMP work?

153Sm-DOTMP is a small molecule that incorporates the radioisotope samarium-153, which emits beta radiation. When administered, it targets areas of increased bone turnover, such as metastatic bone lesions, delivering localized radiation to help alleviate bone pain associated with advanced cancer.