SA53-OS for Cancer

Recruiting at 1 trial location

Overseen By Jill Palmenberg

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Lamassu Bio Inc

Must not be taking: Anticoagulants, Antiplatelets, Corticosteroids

Disqualifiers: HIV, Hepatitis, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called SA53-OS, a potential drug for individuals with difficult-to-treat solid tumors, including advanced liposarcoma and similar cancers. The trial aims to determine the safety and effectiveness of this treatment and how the body processes it. In the first phase, participants will receive varying doses to identify the safest and most effective amount. Once determined, additional participants will receive that specific dose to evaluate its efficacy. Suitable candidates have solid tumors unresponsive to other treatments and a specific tumor profile called "p53 wild-type." As a Phase 1 trial, this research seeks to understand how the treatment works in people, offering participants the chance to be among the first to receive it.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are on corticosteroids, you must stop them at least 2 weeks before starting the study treatment. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that SA53-OS is likely to be safe for humans?

Research has shown that SA53-OS has been safe in previous studies, with no serious side effects or dosage issues. This suggests that participants generally tolerate SA53-OS well. The treatment targets the MDM2 protein, which controls a gene crucial for stopping tumor growth. So far, data indicates that SA53-OS is safe for individuals with solid tumors. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about SA53-OS because it targets cancer in a novel way. While most treatments for cancers such as dedifferentiated liposarcoma (DDLPS) and other p53 wild-type solid tumors focus on general mechanisms like chemotherapy, SA53-OS specifically targets cells with MDM2 amplification and p53 wild-type status. This targeted approach may offer more precise and effective treatment by honing in on specific genetic characteristics of the cancer cells. By potentially minimizing damage to healthy cells, SA53-OS could lead to fewer side effects and improved outcomes compared to traditional therapies.

What evidence suggests that SA53-OS might be an effective treatment for solid tumors?

Research has shown that SA53-OS, a new treatment being tested in this trial for hard-to-treat solid tumors, has promising early results. This trial includes a Phase 1 dose escalation phase and a Phase 2 cohort phase. Studies indicate that SA53-OS targets a protein called MDM2, which often aids cancer cell growth, especially in common types of tumors known as p53 wild-type. Early findings suggest that SA53-OS is generally safe, with no serious side effects reported so far. This treatment has demonstrated initial effectiveness in certain cancers, such as dedifferentiated liposarcoma and other p53 wild-type solid tumors. These results offer hope for its potential to combat these challenging cancers. ^{2 4 6 7 8}

Who Is on the Research Team?

Gabi Hanna, MD

Principal Investigator

Lamassu Bio

Are You a Good Fit for This Trial?

This trial is for adults with advanced or metastatic solid tumors that haven't responded to standard treatments. Participants will be given an oral solution of SA53-OS, a new drug being tested. Key eligibility includes having a specific type of tumor and meeting certain health standards.

Inclusion Criteria

Participants of childbearing/reproductive potential must agree to use adequate birth control measures during the trial and for at least 3 months after discontinuing study treatment.

My tumor is p53 wild-type.

Participants in Phase 2a must have measurable disease by RECIST 1.1.

Exclusion Criteria

Pregnant or lactating women are excluded.

I do not have HIV, hepatitis B, or hepatitis C.

I have not needed blood thinners for a clot in the past 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of SA53-OS to determine the maximum tolerated dose (MTD)

21 days per cycle

Multiple visits per cycle

Dose Expansion

Participants receive SA53-OS at the MTD to assess preliminary efficacy and further safety

Up to 2 years

Every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SA53-OS

Trial Overview The study tests the safety and effectiveness of SA53-OS in two parts: finding the highest dose patients can tolerate without severe side effects (dose escalation), then giving this dose to more patients to see how well it works (dose expansion).

How Is the Trial Designed?

Group I: Phase 2 Experimental Treatment 1 Intervention

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

Group II: Phase 1 Experimental Treatment 1 Intervention

Dose escalation phase

Who Is Running the Clinical Trial?

Lamassu Bio Inc

Lead Sponsor

Trials

1

Recruited

70+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06578624

Safety and Preliminary Efficacy of SA53-OS in Patients ... The objective of this study is to assess the safety, efficacy, and pharmacokinetics of SA53-OS in adult participants with refractory solid tumors.

2. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/532875

Safety and Preliminary Efficacy of SA53-OS in Patients ... The objective of this study is to assess the safety, efficacy, and pharmacokinetics of SA53-OS in adult participants with refractory solid ...

3. wsav.com wsav.com/business/press-releases/ein-presswire/863303985/sa53-mdm2-inhibitor-lamassu-biotech-reports-significant-progress-favorable-safety-profile-in-phase-1-2a-clinical-trial

SA53 MDM2 Inhibitor: Lamassu Biotech Reports ... According to data reviewed to date, there have been no serious or dose limiting adverse events, and SA53 has thus far demonstrated a favorable ...

4. withpower.com withpower.com/trial/phase-2-tumors-solid-8-2024-48665

SA53-OS for Cancer · Recruiting Participants for Phase ... The objective of this study is to assess the safety, efficacy, and pharmacokinetics of SA53-OS in adult participants with refractory solid tumors.

5. my.clevelandclinic.org my.clevelandclinic.org/clinical-trials/2235-a-phase-12a-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

Clinical Trials To describe any preliminary efficacy of SA53-OS in patients with DD LPS and other p53 wild-type solid tumors. 3.3 Exploratory Objective. To explore potential ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06578624

Safety and Preliminary Efficacy of SA53-OS in Patients ... The objective of this study is to assess the safety, efficacy, and pharmacokinetics of SA53-OS in adult participants with refractory solid tumors.

7. wric.com wric.com/business/press-releases/ein-presswire/863303985/sa53-mdm2-inhibitor-lamassu-biotech-reports-significant-progress-favorable-safety-profile-in-phase-1-2a-clinical-trial

SA53 MDM2 Inhibitor: Lamassu Biotech Reports ... According to data reviewed to date, there have been no serious or dose limiting adverse events, and SA53 has thus far demonstrated a favorable ...

8. synapse.patsnap.com synapse.patsnap.com/drug/198982779c4c4ab59cf35e9bf9da221b

SA53-OS - Drug Targets, Indications, Patents SA53-OS represents a novel approach to cancer therapy, targeting the MDM2 protein, a critical regulator of the tumor suppressor p53 gene.