Phase 1 / Phase 2: testing SA53-OS (phase 1) for Solid Tumor
The objective of this study is to assess the safety, how well it works, 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.
Official registry: https://clinicaltrials.gov/study/NCT06578624 · Lamassu Bio Inc · enrollment listed as 55
What this phase means
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are SA53-OS (phase 1), or SA53-OS (phase 2). The registry lists allocation as randomized. The objective of this study is to assess the safety, how well it works, and pharmacokinetics of SA53-OS in adult participants with refractory solid tumors.
They plan to enroll about 55 people at 3 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
A Phase 1/2a, 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
Interventions: SA53-OS (phase 1), SA53-OS (phase 2)
Primary outcome (registry wording): Phase 1: Incidence of DLT
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- Tumor characteristics of participants in Phase 1
- 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
Who the registry excludes
- Anticipated need for major surgery and/or localized palliative radiation within the next 6 weeks
- 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)
Public study contact (from the registry)
Jill Palmenberg
jill.palmenberg@lamassubio.com
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
3 listed- Gabrail Cancer Center — Canton, Ohio (recruiting)
- University Hospitals Cleveland Medical Center — Cleveland, Ohio (recruiting)
- Cleveland Clinic Taussig Cancer Institute — Cleveland, Ohio (recruiting)
FAQ about this NCT record
Is NCT06578624 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT06578624?
Phase 1 / Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT06578624?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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