RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-03-10

Study Completion:2028-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06578624

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Jill Palmenberg

CONTACT

520-241-5944

jill.palmenberg@lamassubio.com

Principal Investigator

Gabi Hanna, MD

STUDY_DIRECTOR

Lamassu Bio

Study Locations (Sites)

Gabrail Cancer Center

Canton, Ohio, 44718

United States

Cleveland Clinic Taussig Cancer Institute

Cleveland, Ohio, 44195

United States

Collaborators and Investigators

Sponsor: Lamassu Bio Inc

Gabi Hanna, MD, STUDY_DIRECTOR, Lamassu Bio

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-10

Study Completion Date2028-12

Study Record Updates

Study Start Date2025-03-10

Study Completion Date2028-12

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Solid Tumor