Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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

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. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

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.

Primary Outcome

Incidence of DLT in Cycle 1 (Day 1 to 21)

Conditions Studied

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
Lamassu Bio

1 total trials

What NCT06578624 shows while recruiting

NCT06578624 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 221-participant average among 196 other Solid Tumor trials with a reported enrollment target (68% lower).

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 a single indexed study location in 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.

Similar trials for Solid Tumor

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06578624's enrollment target sits among peer trials

70 104th of 196 higher than 90 of 196 other Solid Tumor trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Solid Tumor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT00969111 · 70 participants · NA

    Postoperative or Salvage Radiotherapy (RT) for Node Negative Prostate Cancer Following Radical Prostatectomy

  • NCT01712620 · 70 participants · Phase 2

    Spironolactone for Pulmonary Arterial Hypertension

  • NCT02143830 · 70 participants · Phase 2

    HSCT for Patients With Fanconi Anemia Using Risk-Adjusted Chemotherapy

  • NCT02601339 · 70 participants

    NIRS Monitoring in Premature Infants

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Source: ClinicalTrials.gov NCT06578624, the US trial registry maintained by the National Library of Medicine. NCT06578624 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.