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

Part of paid clinical trials in Canton, Ohio.

Sponsor
Lamassu Bio Inc
Study ID
NCT06578624
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SA53-OS (phase 1) — DRUG
    Dose escalation phase in which participants receive SA53-OS on 3 consecutive days every 3 weeks for a maximum of 2 years. Single participant cohorts will be enrolled until a Grade 2 or greater toxicity is observed and then 3+3 multi-participant cohorts will be enrolled until the MTD is identified.
  • SA53-OS (phase 2) — DRUG
    Dose expansion phase in which participants receive SA53-OS on 3 consecutive days every 3 weeks for a maximum of 2 years at the MTD identified in phase 1.

Study Details

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.

Key Dates

Start date
Mar 10, 2025
Status verified
Jun 2025
Primary completion
Mar 31, 2026
Completion
Dec 31, 2028

Study Design

Enrollment
70 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1
    Dose escalation phase
  • Experimental: Phase 2
    Cohort A: DDLPS (MDM2 amplified and p53 wild-type) Cohort B: other p53 wild-type solid tumors

Primary Outcome Measure

Phase 1: Incidence of DLT [ Time Frame: 21 days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Gabrail Cancer CenterCantonOhio44718
Carrie Smith, RN
[email protected]
330-492-3345
Nashat Gabrail, MD (PRINCIPAL_INVESTIGATOR)
Cleveland Clinic Taussig Cancer InstituteClevelandOhio44195
Cancer Answer Line
[email protected]
866-223-8100
James Wooley (PRINCIPAL_INVESTIGATOR)

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By research site
Gabrail Cancer Center· Canton, OHCleveland Clinic Taussig Cancer Institute· Cleveland, OH

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