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NCT06578624 · ClinicalTrials.gov registry record · Phase 1

Safety and Preliminary Efficacy of SA53-OS in Patients With Locally Advanced or Metastatic Solid Tumors

A Phase 1 study of Solid Tumor, sponsored by Lamassu Bio.

Recruiting
Registry status
Phase 1
Development phase
70
Enrollment target
2
Study locations

NCT06578624 is a Phase 1 study of Solid Tumor that is actively recruiting participants, run by Lamassu Bio. The registered enrollment target is 70 participants, below the 221-participant average among 196 other Solid Tumor trials with a reported enrollment target (68% lower). The trial reports 2 study locations across 1 state.

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The verdict

NCT06578624, a Phase 1 study of Solid Tumor, is actively recruiting participants, sponsored by Lamassu Bio.

RECRUITING
Registry status
Phase 1
Development phase
70 participants
Enrollment target
2
Study locations

Study Summary

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.

Conditions Studied

Solid Tumor

Interventions

  • DRUG SA53-OS (phase 1)
  • DRUG SA53-OS (phase 2)

Study Locations (2)

Ohio

  • Gabrail Cancer Center - Canton
  • Cleveland Clinic Taussig Cancer Institute - Cleveland

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2025-03-10
Est. Completion 2028-12
Phase Phase 1

Sponsor

Lamassu Bio

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06578624

The ClinicalTrials.gov registry entry for NCT06578624 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 221-participant average among 196 other Solid Tumor trials with a reported enrollment target (68% lower). The listed sponsor is Lamassu Bio, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Solid Tumor appearing as the primary indexed condition, and to 2 interventions - of which SA53-OS (phase 1) is the first listed.

NCT06578624 reports 2 study locations spanning 1 distinct geographic area - top geographies include Ohio.

Frequently Asked Questions

What is clinical trial NCT06578624 about?

NCT06578624 is a clinical study titled "Safety and Preliminary Efficacy of SA53-OS in Patients With Locally Advanced or Metastatic Solid Tumors". 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 wh...

What is the current status of trial NCT06578624?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 70 participants. The study started on 2025-03-10. Estimated completion is 2028-12.

What conditions does trial NCT06578624 study?

This clinical trial studies the following conditions: Solid Tumor.

What interventions are being tested in trial NCT06578624?

The interventions under investigation include: SA53-OS (phase 1) (DRUG), SA53-OS (phase 2) (DRUG).

Who is sponsoring clinical trial NCT06578624?

This trial is sponsored by Lamassu Bio, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06578624 being conducted?

This trial has 2 study locations across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.