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Tests treatment safety and results for Solid Tumor
Official title Safety and Preliminary Efficacy of SA53-OS in Patients With Locally Advanced or Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT06578624
What this study is testing
What is SA53-OS (phase 1)?
SA53-OS (phase 1) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- 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...
You likely can't join 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)...
- 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...
See the full eligibility criteria
- 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...
- 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.
- 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...
- 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...
- 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...
- Use or indication for full dose anticoagulation or anti-platelet therapy including low dose aspirin.
- Women who are pregnant or lactating.
The study team makes the final eligibility decision.
Where it's taking place
- Canton, Ohio, United States
- Cleveland, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canton, Ohio, United States; Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.