Actively Recruiting
Safety and Preliminary Efficacy of SA53-OS in Patients With Locally Advanced or Metastatic Solid Tumors
Led by Lamassu Bio Inc · Updated on 2025-06-05
70
Participants Needed
2
Research Sites
194 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The objective of this study is to assess the safety, efficacy, and pharmacokinetics of SA53-OS in adult participants with refractory solid tumors. The study is comprised of 2 parts: Part 1 called dose escalation, and Part 2a called dose expansion. This study starts with Part 1 where participants who are diagnosed with advanced or metastatic solid tumor cancers receive different doses of SA53-OS (starting with the lowest dose) to find the maximum tolerated dose (MTD) of SA53-OS. Once the MTD of SA53-OS is known, the study continues to Part 2a where participants who are diagnosed with dedifferentiated liposarcoma (DD LPS) or other solid tumor cancers will receive SA53-OS at the MTD. The study drug, SA53-OS, will be administered for 3 consecutive days every 3 weeks as an oral solution for up to 2 years.
CONDITIONS
Official Title
Safety and Preliminary Efficacy of SA53-OS in Patients With Locally Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Histologically or cytologically confirmed advanced or metastatic solid tumor or non-Hodgkin lymphoma (excluding primary CNS malignancy) with no effective standard treatment or treatment declined
- For non-Hodgkin lymphoma, failure of at least 2 prior systemic therapies
- Tumor confirmed as p53 wild-type
- For Phase 2a Cohort A: diagnosis of advanced or metastatic dedifferentiated liposarcoma with MDM2 amplification
- For Phase 2a Cohort B: other p53 wild-type solid tumors
- Measurable disease by RECIST 1.1
- Recovery to Grade 1 or less from prior anticancer therapy toxicities
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Agreement to use adequate birth control during and for 3 months after the study if of reproductive potential
You will not qualify if you...
- Planned major surgery or localized palliative radiation within the next 6 weeks
- Active untreated central nervous system metastases
- For treated brain metastases, must be neurologically stable for 4 weeks, off corticosteroids for 2 weeks, and no new growth on re-screening
- Known HIV infection or active hepatitis B or C
- Thrombotic events requiring anticoagulation within 6 months prior to study
- Myocardial infarction within 6 months prior to study
- Significant cardiovascular disease including unstable angina, uncontrolled hypertension or arrhythmia, congestive heart failure NYHA Class III or IV, or severe vascular heart disease
- History of risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
- Known bleeding disorders
- Conditions increasing risk of major bleeding unless resolved
- Use or indication for full dose anticoagulation or anti-platelet therapy including low dose aspirin
- Women who are pregnant or lactating
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Gabrail Cancer Center
Canton, Ohio, United States, 44718
Actively Recruiting
2
Cleveland Clinic Taussig Cancer Institute
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
J
Jill Palmenberg
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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