Main Session
Sep 29
PQA 06 - Genitourinary Cancer, Gynecological Cancer, and Health Care Access and Engagement

3236 - SOLACE: A Phase 1 Pharmacokinetic, Dosimetry, Safety and Dose Optimization Study for a Single Dose of 153 Sm-DOTMP to Treat Metastatic Bone Pain

02:15pm - 03:30pm ET
Poster Hall - Exhibit Hall A
Screen: 22
POSTER

Presenter(s)

Ebrahim Delpassand, MD Headshot
Ebrahim Delpassand, MD - Excel Diagnostics and Nuclear Oncology Center, Houston, TX

E. Delpassand1, J. Peguero2, H. Doddihal3, D. Cade4, and O. Sartor5; 1Excel Diagnostics, Houston, TX, 2Oncology Consultants, Houston, TX, 3Telix Pharmaceuticals, North Melbourne, VIC, Australia, 4Telix Pharmaceuticals, Melbourne, VIC, Australia, 5Medical Oncology Department, East Jefferson/LCMC Health, New Orleans, LA

Purpose/Objective(s):

Patients with bone metastases commonly report pain & significant degradations in quality of life. Current treatment options have limitations, including myelotoxicity, high costs, & possible ineffective relief. Bone pain is one of the most common forms of pain reported by patients with metastatic disease & significantly degrades quality of life.

153Sm-DOTMP is a therapeutic radiopharmaceutical that emits both beta particles & gamma photons to bone metastases. Prior Phase I experience (QSAM-101, n=5) demonstrated no dose-limiting toxicities (DLTs), manageable hematologic toxicity, & early signals of pain relief. Phase 1 Samarium Optimized for Long-lasting Analgesia in Cancerous End-stage bone pain (SOLACE) aims to evaluate PK, dosimetry, safety, & efficacy of a single dose of 153Sm-DOTMP for the treatment of pain associated with metastatic bone cancer.

Materials/Methods:

This open-label, Phase 1 study includes dose escalation (Part A, n=9-15, up to 3 cohorts) & dose selection (Part B, n=18) in patients with painful metastatic bone lesions. In Part A, 3 patients per cohort will be enrolled in parallel into Cohort 1 & 2 & will receive 0.5 mCi/kg or 1.0 mCi/kg of IV 153Sm-DOTMP, respectively. (Cohort 1: 0.5 mCi/kg; Cohort 2: 1.0 mCi/kg; Cohort 3: 1.5 mCi/kg). If no DLT in Cohort 2, 3 patients will enroll in Cohort 3 (1.5 mCi/kg intravenous 153Sm-DOTMP). Cohorts 2 & 3 will enroll 3 additional participants if only 1/3 patients had DLT at that cohort. DLT observation period will be 6w after administration.

Eligible patients will be =18y with histologically confirmed malignancy with multiple metastatic bone lesions including =1 confirmed painful (pain score of =4 on NRS-11) osteoblastic bone tumor that exhibits avid update of 99mTc-diphosphonate bone scans =60 days of 153Sm-DOTMP administration. Patients will have had disease progression while on anti-cancer treatment or ineligible for such treatments with painful bone lesions not amenable to palliative EBRT. Patients must have been receiving a stable regimen of bisphosphonates and/or hormonal or endocrine therapy for =3 months prior to 153Sm-DOTMP administration.

Disclosure: Sponsored by Telix Pharmaceuticals.

Results: N/A

Conclusion: N/A