Evaluating the safety and effectiveness of SA53-OS in patients with advanced solid tumors

A Phase 1/2a, Open-Label Study of Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SA53-OS, an MDM2 Inhibitor, in Patients With Locally Advanced or Metastatic p53 Wild-Type Solid Tumors

This study is testing a new oral medication called SA53-OS to see if it can safely help adults with advanced solid tumors, especially those with dedifferentiated liposarcoma, by promoting tumor cell death.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Lamassu Bio Inc (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 2 sites (Canton, Ohio and 1 other locations)
• Trial ID: NCT06578624 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety, efficacy, and pharmacokinetics of a novel MDM2 inhibitor, SA53-OS, in adult patients with refractory solid tumors. The study is divided into two parts: a dose escalation phase to determine the maximum tolerated dose (MTD) and a dose expansion phase focusing on patients with dedifferentiated liposarcoma (DD LPS) and other solid tumors. Participants will receive SA53-OS as an oral solution for three consecutive days every three weeks, potentially for up to two years. The trial will evaluate the drug's ability to activate the p53 tumor suppressor protein, facilitating tumor cell death and growth inhibition.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with p53 wild-type refractory solid tumors, particularly those with dedifferentiated liposarcoma or other solid tumors.

Not a fit: Patients with primary central nervous system malignancies or those who have not experienced prior systemic therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that currently have limited effective treatments.

How similar studies have performed: While this approach is novel, similar studies targeting MDM2 inhibition have shown promise in early phases.

Eligibility criteria

Inclusion Criteria:

* Tumor characteristics of participants in Phase 1

  1. Histologically and/or cytologically confirmed diagnosis of advanced or metastatic solid tumor and/or non-Hodgkin lymphoma excluding primary central nervous system malignancy for which no standard effective treatment exists or where that treatment was declined. Participants with non-Hodgkin lymphoma should have failed ≥ 2 prior lines of systemic therapy prior enrollment.
  2. Tumor p53 wild-type.
* Tumor characteristics of participants in Phase 2a

  1. Cohort A: Tumor p53 wild-type with histologically confirmed diagnosis of advanced or metastatic DD LPS (and MDM2 amplification); OR Cohort B: Tumor p53 wild-type in other solid tumor.
  2. Measurable disease by RECIST 1.1.
* 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 Criteria:

* 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.

Where this trial is running

Canton, Ohio and 1 other locations

• Gabrail Cancer Center — Canton, Ohio, United States (Recruiting)
• Cleveland Clinic Taussig Cancer Institute — Cleveland, Ohio, United States (Recruiting)

Study contacts

• Study coordinator: Jill Palmenberg

Conditions Solid Tumor; p53 wild-type tumor; liposarcoma; MDM2 inhibitor; solid tumors; dedifferentiated liposarcoma; p53; Advanced or metastatic solid tumors