Recruiting
Phase 1
Phase 2

SA53-OS

Sponsor:

Lamassu Bio Inc

Code:

NCT06578624

Conditions

Solid Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

SA53-OS (phase 1)

SA53-OS (phase 2)

Study Details

Brief summary:

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

Solid Tumor

Study ID

NCT06578624

Start date

Mar 10, 2025

Status verified date

Aug, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

70 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase 1

Dose escalation phase

experimental: Phase 2

Cohort A: DDLPS (MDM2 amplified and p53 wild-type) Cohort B: other p53 wild-type solid tumors

Interventions

SA53-OS (phase 1)

Dose escalation phase in which participants receive SA53-OS on 3 consecutive days every 3 weeks for a maximum of 2 years. Single participant cohorts will be enrolled until a Grade 2 or greater toxicity is observed and then 3+3 multi-participant cohorts will be enrolled until the MTD is identified.

SA53-OS (phase 2)

Dose expansion phase in which participants receive SA53-OS on 3 consecutive days every 3 weeks for a maximum of 2 years at the MTD identified in phase 1.

Primary outcome measure

  • Phase 1: Incidence of DLT [ Time Frame: 21 days ]
  • Phase 1 and 2: Adverse events [ Time Frame: Approximately 2 years ]

Central Contacts and Locations

Central contacts

Jill Palmenberg

520-241-5944jill.palmenberg@lamassubio.com

Locations

Gabrail Cancer Center

Recruiting

Canton, Ohio, United States, 44718

Contacts

Jill Palmenberg

520-241-5944jill.palmenberg@lamassubio.com

Principal Investigator:

Nashat Gabrail, MD

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Megan Boland

216-286-3379megan.boland@UHhospitals.org

Emily Beyer

216-286-3029emily.beyer@UHhospitals.org

Principal Investigator:

Afshin Dowlati, MD

Cleveland Clinic Taussig Cancer Institute

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Cancer Answer Line

866-223-8100canceranswer@ccf.org

Principal Investigator:

James Wooley

More Information

Sponsor

Lamassu Bio Inc

Last update posted

Sep 9, 2026

Last verified

Aug, 2026

Keywords

  • p53 wild-type tumor
  • liposarcoma
  • MDM2 inhibitor
  • solid tumors
  • dedifferentiated liposarcoma (DD LPS)
  • p53
  • Advanced or metastatic solid tumors

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Lamassu Bio Inc on 2026-09-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.