Can a new pill shrink Hard-to-Treat tumors?
NCT ID NCT06578624
First seen Aug 18, 2026 · Last updated Sep 10, 2026 · Updated 4 times
Summary
This trial is testing an experimental drug called SA53-OS in people with advanced or metastatic solid tumors that have not responded to standard treatments. The drug works by blocking a protein called MDM2, which may help slow or stop tumor growth. The study has two parts: first, finding the safest dose, then testing that dose in a larger group to see if it shows promise.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SA53-OS, an experimental MDM2 inhibitor taken as an oral solution
- What this could lead to
- If successful, this could lead to a new treatment option for people with advanced solid tumors that have not responded to standard therapies.
- What could go wrong
- This is an early-phase trial, so the drug may not be effective or may cause significant side effects. The results will only show preliminary safety and dosing, not a proven cure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cleveland Clinic Taussig Cancer Institute
RECRUITINGCleveland, Ohio, 44195, United States
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Gabrail Cancer Center
RECRUITINGCanton, Ohio, 44718, United States
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University Hospitals Cleveland Medical Center
RECRUITINGCleveland, Ohio, 44106, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- First human test of BI 4060107 aims to find safe dose for Hard-to-Treat tumors
- Can a new drug shield kidneys from chemotherapy damage?
- Double-Drug attack on Hard-to-Treat lymphomas
- Mining Responders' tumors for clues to a universal cancer therapy
- Patient's own t cells engineered to hunt lymphoma in early trial
- Proton boost radiotherapy aims to hit large tumors harder while sparing healthy tissue