SA53-OS for Cancer

Recruiting at 1 trial location

Overseen By Jill Palmenberg

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Lamassu Bio Inc

Must not be taking: Anticoagulants, Antiplatelets, Corticosteroids

Disqualifiers: HIV, Hepatitis, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

70 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Gabi Hanna, MD

Principal Investigator

Lamassu Bio

Eligibility Criteria

This trial is for adults with advanced or metastatic solid tumors that haven't responded to standard treatments. Participants will be given an oral solution of SA53-OS, a new drug being tested. Key eligibility includes having a specific type of tumor and meeting certain health standards.

Inclusion Criteria

Participants of childbearing/reproductive potential must agree to use adequate birth control measures during the trial and for at least 3 months after discontinuing study treatment.

My tumor is p53 wild-type.

Participants in Phase 2a must have measurable disease by RECIST 1.1.

Exclusion Criteria

Pregnant or lactating women are excluded.

I do not have HIV, hepatitis B, or hepatitis C.

I have not needed blood thinners for a clot in the past 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of SA53-OS to determine the maximum tolerated dose (MTD)

21 days per cycle

Multiple visits per cycle

Dose Expansion

Participants receive SA53-OS at the MTD to assess preliminary efficacy and further safety

Up to 2 years

Every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• SA53-OS

Trial Overview The study tests the safety and effectiveness of SA53-OS in two parts: finding the highest dose patients can tolerate without severe side effects (dose escalation), then giving this dose to more patients to see how well it works (dose expansion).

Participant Groups

Group I: Phase 2 Experimental Treatment 1 Intervention

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

Group II: Phase 1 Experimental Treatment 1 Intervention

Dose escalation phase

Who Is Running the Clinical Trial?

Lamassu Bio Inc

Lead Sponsor

Trials

1

Recruited

70+