Safety and Preliminary Efficacy of SA53-OS in Patients With Locally Advanced or Metastatic Solid Tumors
NCT Number: NCT06578624
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Solid Tumor
Interventions: DRUG: SA53-OS (phase 1)|DRUG: SA53-OS (phase 2)
Sponsor: Lamassu Bio Inc
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2028-06
Locations: Cleveland Clinic Taussig Cancer Institute, Cleveland, Ohio, 44195, United States

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 Measures: Phase 1: Incidence of DLT, Incidence of DLT in Cycle 1 (Day 1 to 21), 21 days|Phase 1 and 2: Adverse events, Frequency of adverse events, Approximately 2 years
Secondary Outcome Measures: Phase 1: Peak plasma concentration, Determine the pharmacokinetic profile of SA53-OS (Cmax), Day 4|Phase 1: Area under the plasma concentration versus time curve between 0 and 24 hours, Determine the pharmacokinetic profile of SA53-OS (AUC0-24), Day 4|Phase 1: Half-life, Determine the pharmacokinetic profile of SA53-OS (T1/2), Day 4|Phase 2: Objective response rate (ORR), Participants achieving ORR defined as complete response (CR) rate plus partial response (PR) rate.

CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.

PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters., Approximately 2 years|Phase 2: Progression free survival (PFS), Participants not meeting the definition for progressive disease, Approximately 2 years|Phase 2: Overall survival, To evaluate overall survival, Approximately 2 years|Phase 2: Duration of response, Duration of response will be evaluated in responders, Approximately 2 years|Phase 2: Complete response rate, Participants achieving CR defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm., Approximately 2 years|Phase 2: Stable disease rate, Participants achieving stable disease defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease., Approximately 2 years|Phase 2: Disease control rate, Participants achieving CR + PR + stable disease, Approximately 2 years