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SA53-OS for Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by Lamassu Bio Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must be 18 years old or older.
Participants in Phase 1 must have tumor p53 wild-type.
Must not have
Exclusion criteria include known HIV infection or active hepatitis B or C infection.
Participants with a thrombotic event requiring active and ongoing anticoagulation within the last 6 months prior to study treatment are excluded.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 2 years
Awards & highlights

Summary

"This trial aims to test the safety, effectiveness, and how the body processes SA53-OS in adults with tough-to-treat solid tumors. The trial has two parts: one where different doses of

Who is the study for?
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.
What is being tested?
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).
What are the potential side effects?
Possible side effects are not detailed here but may include typical reactions seen with cancer therapies such as nausea, fatigue, allergic reactions, or other organ-specific issues depending on the patient's response to SA53-OS.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My tumor is p53 wild-type.
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My side effects from previous cancer treatments are mild or gone.
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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have HIV, hepatitis B, or hepatitis C.
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I have not needed blood thinners for a clot in the past 6 months.
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I have not had a heart attack in the last 6 months.
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I do not have severe heart problems like unstable angina, uncontrolled high blood pressure, serious arrhythmias, or severe heart failure.
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I do not have a bleeding disorder like hemophilia.
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I am not on any blood thinners or aspirin.
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I expect to need major surgery or targeted relief radiation soon.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Phase 1 and 2: Adverse events
Phase 1: Incidence of DLT
Secondary study objectives
Phase 1: Area under the plasma concentration versus time curve between 0 and 24 hours
Phase 1: Half-life
Phase 1: Peak plasma concentration
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Phase 2Experimental Treatment1 Intervention
Cohort A: DDLPS (MDM2 amplified and p53 wild-type) Cohort B: other p53 wild-type solid tumors
Group II: Phase 1Experimental Treatment1 Intervention
Dose escalation phase

Find a Location

Who is running the clinical trial?

Lamassu Bio IncLead Sponsor
~47 spots leftby Aug 2025
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