NCT04720664

Oral SM-88 in Patients With Metastatic HR+/HER2- Breast Cancer

OASIS: Phase II Trial of OrAl SM-88 in Patients With Metastatic Hormone Receptor-posItive HER2-negative (HR+/HER2-) breaSt Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Georgetown University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II single arm, open-label study of SM-88 used with methoxsalen, phenytoin, and sirolimus (MPS) in metastatic HR+/HER2- breast cancer. It is designed to determine efficacy, defined as the objective response rate (ORR) of this investigational treatment. It is hypothesized that SM-88 used with MPS will lead to significant anti-tumor responses with acceptable toxicities in patients with metastatic HR+/HER2- breast cancer.

Detailed description

This is a multicenter phase II single arm trial designed to evaluate the efficacy of SM-88 plus three subtherapeutic conditioning agents (methoxsalen, phenytoin, and sirolimus \[MPS\]) in patients with metastatic HR+/HER2- breast cancer. . Thirty patients will be enrolled in first stage of the study, and if 3 or more patients have an objective response (complete or partial response) then an additional 20 patients will be enrolled in the second stage of the study. Patients will receive the recommended phase 2 dose (RP2D) of SM-88 (460 mg by mouth \[PO\] twice a day \[BID\] D1 - 28) as well as three conditioning agents (MPS): methoxsalen (10 mg PO daily \[Qd\] D1 - 28), phenytoin (50 mg PO Qd D1 - 28), and sirolimus (0.5 mg PO Qd D1 - 28). Assessment of efficacy will be conducted every 3 cycles (approximately every 12 weeks) with CT chest/abdomen/pelvis using RECIST v1.1 criteria. Safety including clinic visits, and exams will occur every 4 weeks on Day 1 of each cycle. Laboratory testing will be performed every 2 weeks for the first 2 cycles and then on Day 1 of each subsequent cycle.

Conditions

• Breast Cancer
• Metastatic Breast Cancer
• Hormone Receptor Positive Breast Carcinoma

Interventions

Type	Name	Description
DRUG	SM-88	* SM-88, Two 230 mg capsules taken orally twice daily (920 mg daily). * Methoxsalen, One 10 mg capsule taken orally once daily. * Phenytoin, One 50 mg tablet taken orally once daily. * Sirolimus, One 0.5 mg tablet taken orally once daily.

Timeline

• Start date: 2021-09-22
• Primary completion: 2023-02-10
• Completion: 2023-02-10
• First posted: 2021-01-22
• Last updated: 2023-08-28
• Results posted: 2023-08-28

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study