Skip to content
DataLookout
Start free
Menu

NCT06578624

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

StatusRecruiting
PhasePhase 1/2
Primary completion (estimated)

At risk: Primary completion moved at least 5 years 3 months later across 2 updates, enrollment reduced 21%.

See at-risk trials from Lamassu Bio Inc

Track this trial

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Record History

All 8 versions: 8 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Dec 2026 to Jul 1, 2031 Show 5 more changesShow less
    • Start date pushed from Mar 10, 2025 to Jun 16, 2025
    • Eligibility criteria expanded, about 21 words
    • Enrollment reduced: 70 → 55 participants
    • Study completion pushed from Dec 2028 to Aug 1, 2031
    • Secondary endpoints: details revised at 3 of 10 entries
  2. Site contacts updated at 1 of 3 sitesv7
  3. Site contacts updated at 1 of 3 sitesv6
  4. Primary completion pushed from Mar 2026 to Dec 2026
    • Study sites: 2 to 3
    v5
  5. Site details revised at 1 of 2 sitesv4
Show 2 earlier versionsHide 2 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Feb 2026 to Mar 2026
    • Start date changed from estimate of Feb 2025 to Mar 10, 2025
    • Site details revised at 2 of 2 sites
    v3
  2. Start date: Sep 2024 to Feb 2025
    • Study sites: 1 to 2
    • Primary completion date: Aug 2025 to Feb 2026
    • Study completion date: Jun 2028 to Dec 2028
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Phase 1: Incidence of DLT
Timeframe: 21 days
Phase 1 and 2: Adverse events
Timeframe: Approximately 2 years

Secondary (10)

Phase 1: Peak plasma concentration
Phase 1: Area under the plasma concentration versus time curve between 0 and 24 hours
Phase 1: Half-life
Phase 2: Objective response rate (ORR)
Phase 2: Progression free survival (PFS)
Show 5 moreShow less
Phase 2: Overall survival
Phase 2: Duration of response
Phase 2: Complete response rate
Phase 2: Stable disease rate
Phase 2: Disease control rate

Arms and interventions

Phase 1Experimental

Dose escalation phase

Phase 2Experimental

Cohort A: DDLPS (MDM2 amplified and p53 wild-type) Cohort B: other p53 wild-type solid tumors

Drugs: SA53-OS (phase 1), SA53-OS (phase 2)

Sites

3 sites in 1 country