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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

March 10, 2025

Primary Completion Date

March 31, 2026

Study Completion Date

December 31, 2028

Conditions
Solid Tumor
Interventions
DRUG

SA53-OS (phase 1)

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.

DRUG

SA53-OS (phase 2)

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.

Trial Locations (2)

44195

RECRUITING

Cleveland Clinic Taussig Cancer Institute, Cleveland

44718

RECRUITING

Gabrail Cancer Center, Canton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Lamassu Bio Inc

INDUSTRY