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Oral SM-88 in Patients With Metastatic HR+/HER2- 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
350 Previous Clinical Trials
139,154 Total Patients Enrolled
Tyme, IncIndustry Sponsor
4 Previous Clinical Trials
184 Total Patients Enrolled
Julie Collins, MD MPHPrincipal InvestigatorGeorgetown University
Nadia Ashai, MDPrincipal InvestigatorGeorgetown University
Candace Mainor, MDPrincipal InvestigatorGeorgetown University
3 Previous Clinical Trials
110 Total Patients Enrolled
~3 spots leftby Dec 2025
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