Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06578624
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-15
Brief Title:
Safety and Preliminary Efficacy of SA53-OS in Patients With Locally Advanced or Metastatic Solid Tumors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 12a Open-Label Study of Safety Tolerability Pharmacokinetics and Preliminary Efficacy of SA53-OS an MDM2 Inhibitor in Patients With Locally Advanced or Metastatic p53 Wild-Type Solid Tumors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
This is a phase 12a open-label dose escalation study conducted in adult participants with p53 wild-type refractory solid tumors The study will assess the safety efficacy and pharmacokinetics of SA53-OS a novel MDM2 inhibitor capable of selective activation of p53 This enables the p53 tumor suppressor protein to selectively facilitate tumor cell death and growth inhibition
The study drug SA53-OS will be administered for 3 consecutive days every 3 weeks as an oral solution Phase 1 will consist of a dose escalation study to establish a candidate recommended phase 2 dose RP2D Phase 2a will enroll 2 expansion cohorts to establish any preliminary efficacy of SA53-OS in participants with dedifferentiated liposarcoma DD LPS with MDM2 amplifications and other p53 wild-type solid tumors as a single agent
Phase 1 dose escalation
Escalating doses of SA53-OS will be provided to participants with p53 wild-type refractory solid tumors to determine the RP2D The MTD is the highest dose of a drug or treatment that does not cause unacceptable side effects in the first cycle The RP2D considers all available safety pharmacokinetics and efficacy data including the frequency severity and manageability of toxicities occurring after Cycle 1
Phase 1 of the study will start with dose escalation by 2-fold ie 2x preceding dose level in cohorts of a single participant until Grade 2 or greater toxicity is observed
When a single Grade 2 or higher toxicity is observed 33 multi-participant cohorts will be treated at the dose in which the Grade 2 or higher toxicity was observed by enrolling another 2 participants at this dose The 33 multi-participant cohorts will follow the standard 33 paradigm based on occurrence of any DLT with 50 dose escalation until the MTD is identified
Phase 2a dose expansion
The purpose of Phase 2a of the study is to describe any preliminary evidence of efficacy from SA53-OS monotherapy in participants with DD LPS or other p53 wild-type or MDM2 amplified solid tumors Phase 2a will also be used to confirm the safety and tolerability of the candidate RP2D of SA53-OS determined in Phase 1 of the study to further describe the toxicity and pharmacokinetics profiles of SA53-OS and to assess potential biomarkers of sensitivity resistance and toxicity
Participants will continue to receive study treatment until either 1 disease progression 2 occurrence of unacceptable treatment-related toxicity as per participant or Investigator discretion 3 the maximum of 2 years of treatment has been reached or 4 other reasons for study treatment discontinuation In the case of complete response treatment should be continued for at least 6 months if no other stopping criteria are met and further treatment can be recommended at the investigators discretion
The study drug SA53-OS will be administered for 3 consecutive days every 3 weeks as an oral solution Phase 1 will consist of a dose escalation study to establish a candidate recommended phase 2 dose RP2D Phase 2a will enroll 2 expansion cohorts to establish any preliminary efficacy of SA53-OS in participants with dedifferentiated liposarcoma DD LPS with MDM2 amplifications and other p53 wild-type solid tumors as a single agent
Phase 1 dose escalation
Escalating doses of SA53-OS will be provided to participants with p53 wild-type refractory solid tumors to determine the RP2D The MTD is the highest dose of a drug or treatment that does not cause unacceptable side effects in the first cycle The RP2D considers all available safety pharmacokinetics and efficacy data including the frequency severity and manageability of toxicities occurring after Cycle 1
Phase 1 of the study will start with dose escalation by 2-fold ie 2x preceding dose level in cohorts of a single participant until Grade 2 or greater toxicity is observed
When a single Grade 2 or higher toxicity is observed 33 multi-participant cohorts will be treated at the dose in which the Grade 2 or higher toxicity was observed by enrolling another 2 participants at this dose The 33 multi-participant cohorts will follow the standard 33 paradigm based on occurrence of any DLT with 50 dose escalation until the MTD is identified
Phase 2a dose expansion
The purpose of Phase 2a of the study is to describe any preliminary evidence of efficacy from SA53-OS monotherapy in participants with DD LPS or other p53 wild-type or MDM2 amplified solid tumors Phase 2a will also be used to confirm the safety and tolerability of the candidate RP2D of SA53-OS determined in Phase 1 of the study to further describe the toxicity and pharmacokinetics profiles of SA53-OS and to assess potential biomarkers of sensitivity resistance and toxicity
Participants will continue to receive study treatment until either 1 disease progression 2 occurrence of unacceptable treatment-related toxicity as per participant or Investigator discretion 3 the maximum of 2 years of treatment has been reached or 4 other reasons for study treatment discontinuation In the case of complete response treatment should be continued for at least 6 months if no other stopping criteria are met and further treatment can be recommended at the investigators discretion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None