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

First listed
Aug 29, 2024
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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