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SM-88 for Breast Cancer (OASIS Trial)

Phase 2
Waitlist Available
Led By Julie Collins, MD MPH
Research Sponsored by Georgetown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the time of the administration of study drug until discontinuation of therapy (every 4 weeks on day 1 of each cycle in a 28 day cycle; approximately 3 months)
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a new drug combination (SM-88 with three other medications) in patients with a specific type of advanced breast cancer. The goal is to see if this combination can effectively fight the cancer with manageable side effects.

Eligible Conditions
  • Breast Cancer
  • Breast cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the time of the administration of study drug until discontinuation of therapy (every 4 weeks on day 1 of each cycle in a 28 day cycle; approximately 3 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the time of the administration of study drug until discontinuation of therapy (every 4 weeks on day 1 of each cycle in a 28 day cycle; approximately 3 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Objective Response Rate (ORR)
Secondary study objectives
Clinical Benefit Rate (CBR) at ≥ 24 Weeks
Duration of Response (DOR)
Incidence of Treatment-Related Adverse Events [Safety and Tolerability]
+1 more
Other study objectives
Changes in cell free DNA (cfDNA)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: oral SM-88Experimental Treatment1 Intervention
SM-88 taken with three conditioning agents: methoxsalen, phenytoin, and sirolimus

Find a Location

Who is running the clinical trial?

Georgetown UniversityLead Sponsor
348 Previous Clinical Trials
137,291 Total Patients Enrolled
32 Trials studying Breast Cancer
11,164 Patients Enrolled for Breast Cancer
Tyme, IncIndustry Sponsor
4 Previous Clinical Trials
184 Total Patients Enrolled
1 Trials studying Breast Cancer
Julie Collins, MD MPHPrincipal InvestigatorGeorgetown University
~3 spots leftby Nov 2025
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