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SA53-OS for Advanced Solid Tumors

This study is testing a drug called SA53-OS in adults with advanced or metastatic solid tumors (cancers that have spread) for which standard treatments are no longer working or have been declined. The main goals are to see how safe SA53-OS is, how well it works, and how the body processes it. The study has two parts: first, different doses of SA53-OS are given to find the highest dose that is safe (maximum tolerated dose or MTD). Then, in the second part, participants receive SA53-OS at that MTD. SA53-OS is designed to activate a protein called p53, which can help kill cancer cells. You would receive SA53-OS for three days every three weeks for up to two years.

Study design
This is an open-label study, meaning both you and the study team will know which treatment you are receiving. It is designed to enroll 70 participants and has two phases: dose escalation and dose expansion.
What's involved
You would receive SA53-OS as an oral solution for three consecutive days every three weeks. This treatment period could last for a maximum of two years.
Compensation
Not stated in the trial record.
Follow-up
The study will track adverse events (side effects) for approximately two years.

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NCT06578624

Safety and Preliminary Efficacy of SA53-OS in Patients With Locally Advanced or Metastatic Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Lamassu Bio Inc
~70 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:SA53-OS (phase 1)SA53-OS (phase 2)

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1: Incidence of DLT
Measured over 21 days
+1 more outcome measured

Conditions

Solid Tumor

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Where it's being run

3 sites across 1 states
Ohio3

Study leadership

  • Gabi Hanna, MD · STUDY_DIRECTOR · Lamassu Bio

Who to contact

Jill Palmenberg
[email protected]
520-241-5944
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Tumor characteristics of participants in Phase 1
Tumor characteristics of participants in Phase 2a
18 years old or older.
Resolution of clinically relevant toxicity-related to prior anticancer therapies prior to receipt of study treatment to Grade 1 or less.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Participants of childbearing/reproductive potential must agree to use adequate birth control measures during the course of the trial and for at least 3 months after discontinuing study treatment.

Exclusion

Anticipated need for major surgery and/or localized palliative radiation within the next 6 weeks
Active, untreated central nervous system metastases. Participants with brain metastases identified at Screening may be rescreened after the lesion(s) have been appropriately treated; participants with treated brain metastases should be neurologically stable for 4 weeks post-treatment and prior to study enrollment, and off corticosteroids for at least 2 weeks before start of study treatment, and treated lesions should demonstrate no new growth on the re-screening scan.
Known HIV infection or active hepatitis B or C infection.
Thrombotic event requiring active and ongoing anticoagulation within the last 6 months prior to study treatment.
Myocardial infarction within the last 6 months prior to study treatment.
Significant cardiovascular disease including unstable angina pectoris, uncontrolled hypertension or arrhythmia, congestive heart failure New York Heart Association (NYHA) Class III or IV related to primary cardiac disease, uncontrolled ischemic or severe vascular heart disease.
A history of additional risk factors for Torsades de Pointes (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
Known bleeding disorder (e.g., hemophilia, von Willebrand disease).
Conditions that may predispose to major bleeding (e.g., active GI ulcers, upper or lower GI bleedings in the last 6 months, significant hemoptysis in the last 6 months, tumor invasion of major vessels, etc.). Conditions that have been treated may be allowed if resolution of the risk is documented.
Use or indication for full dose anticoagulation or anti-platelet therapy including low dose aspirin.
Women who are pregnant or lactating.

What this trial measures

  • Phase 1: Incidence of DLT21 days

    Incidence of DLT in Cycle 1 (Day 1 to 21)

  • Phase 1 and 2: Adverse eventsApproximately 2 years

    Frequency of adverse events