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

NCT06578624 | Recruiting Phase 1 FDA Drug

• 1 other identifier: LB-SA53-101
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Phase 1: Incidence of DLT

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

  21 days

• Phase 1 and 2: Adverse events

  Frequency of adverse events

  Approximately 2 years

Secondary Outcomes (10)

• Phase 1: Peak plasma concentration

  Day 4

• Phase 1: Area under the plasma concentration versus time curve between 0 and 24 hours

  Day 4

• Phase 1: Half-life

  Day 4

• Phase 2: Objective response rate (ORR)

  Approximately 2 years

• Phase 2: Progression free survival (PFS)

  Approximately 2 years

Study Arms (2)

Phase 1

EXPERIMENTAL

Dose escalation phase

Drug: SA53-OS (phase 1)

Phase 2

EXPERIMENTAL

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

Drug: SA53-OS (phase 2)

Interventions

SA53-OS (phase 1) DRUG

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.

Phase 1

SA53-OS (phase 2) DRUG

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.

Phase 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Tumor characteristics of participants in Phase 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.
• Tumor p53 wild-type.
• Tumor characteristics of participants in Phase 2a
• 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.
• Measurable disease by RECIST 1.1.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lamassu Bio Inc: lead

Study Sites (2)

Gabrail Cancer Center

Canton, Ohio, 44718, United States

RECRUITING

Cleveland Clinic Taussig Cancer Institute

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Liposarcoma

Interventions

Clinical Trials, Phase I as Topic; Clinical Trials, Phase II as Topic

Condition Hierarchy (Ancestors)

Neoplasms, Adipose Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Intervention Hierarchy (Ancestors)

Clinical Trials as Topic; Clinical Studies as Topic; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Gabi Hanna, MD

  Lamassu Bio

  STUDY DIRECTOR

Central Study Contacts

Jill Palmenberg

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 1 of the study will start with dose escalation by 2-fold (i.e., 2x preceding dose level) in cohorts of a single participant until Grade 2 or greater toxicity is observed. When a single Grade 2 or higher toxicity is observed, 3+3 multi-participant cohorts will be treated at the dose in which the Grade 2 or higher toxicity was observed by enrolling another 2 participants at this dose. The 3+3 multi-participant cohorts will follow the standard 3+3 paradigm based on occurrence of any DLT with 50% dose escalation until the MTD is identified. In phase 2 of the study, the MTD will be administered to 2 cohorts of 20 participants each: Cohort A) with known MDM2 amplified DD LPS; Cohort B) p53 wild-type solid tumors.

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: August 29, 2024
• Study Start: March 10, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 5, 2025

Record last verified: 2025-06

Locations

US (2)