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Trial of Pembrolizumab/Chemotherapy With Live Biotherapeutic Product, MO-03, in Patients With Early Stage Triple Negative Breast Cancer

NCT07552181 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-05-06

No results posted yet for this study

Summary

This is a single-arm and single site phase II trial combination of chemotherapy and pembrolizumab with LBP MO-03 in 50 trial participants with early triple negative breast cancer. MO-03 will be given at a dose of 4 x 10e9 CFU per capsule, 1 capsule taken orally twice daily. Patients will receive standard of care pembrolizumab 200 mg every 3 weeks in concurrent with a regimen of chemotherapy. Please refer to Table 2 for a summary of the chemo-immunotherapy with pembrolizumab containing regimens. Patients will continue to take MO-03 up until the day prior to surgery (lumpectomy or mastectomy). Post-surgery, patients will come in for a 2-week follow-up and then enter survival follow-up annually for 5 years.

Conditions

  • TNBC - Triple-Negative Breast Cancer
  • TNBC
  • Early Stage Triple-Negative Breast Carcinoma

Interventions

DRUG

Live biotherapeutic product: MO-03 1 capsule PO BID

Live biotherapeutic product: MO-03 1 capsule PO BID + standard of care pembrolizumab and carbo-docetaxel or carbo-paclitaxel followed by Adriamycin cyclophosphamide

Sponsors & Collaborators

  • Osel, Inc.

    collaborator INDUSTRY

  • Miyarisan Pharmaceuticals, Co., Ltd.

    collaborator UNKNOWN

  • Yuan Yuan

    lead OTHER

Principal Investigators

  • Yuan Yuan, MD · Cedars-Sinai Medical Center

  • Jin Sun Lee-Bitar, MD · Cedars-Sinai Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2035-09-30
Completion
2035-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07552181 on ClinicalTrials.gov