OncoMatch/Clinical Trials/NCT06578624
Safety and Preliminary Efficacy of SA53-OS in Patients With Locally Advanced or Metastatic Solid Tumors
Is NCT06578624 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments including SA53-OS (phase 1) and SA53-OS (phase 2) for solid tumor.
Treatment: SA53-OS (phase 1) · SA53-OS (phase 2) — 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. This study starts with Part 1 where participants who are diagnosed with advanced or metastatic solid tumor cancers receive different doses of SA53-OS (starting with the lowest dose) to find the maximum tolerated dose (MTD) of SA53-OS. Once the MTD of SA53-OS is known, the study continues to Part 2a where participants who are diagnosed with dedifferentiated liposarcoma (DD LPS) or other solid tumor cancers will receive SA53-OS at the MTD. The study drug, SA53-OS, will be administered for 3 consecutive days every 3 weeks as an oral solution for up to 2 years.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Tumor Agnostic
Biomarker criteria
Required: MDM2 amplification
Required: TP53 wild-type
Disease stage
Required: Stage IV
Metastatic disease required
advanced or metastatic solid tumor and/or non-Hodgkin lymphoma; Measurable disease by RECIST 1.1
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic therapy
Participants with non-Hodgkin lymphoma should have failed 2 prior lines of systemic therapy prior enrollment
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Gabrail Cancer Center · Canton, Ohio
- Cleveland Clinic Taussig Cancer Institute · Cleveland, Ohio
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06578624 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received systemic therapy.
Does this trial require MDM2?
Yes, MDM2 amplification is a required biomarker for enrollment.
Does this trial require TP53?
Yes, TP53 wild-type is a required biomarker for enrollment.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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