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NCT07552181 · ClinicalTrials.gov registry record · Phase 2
Phase II Trial of Pembrolizumab/Chemotherapy With Live Biotherapeutic Product MO-03 in Patients With Early Stage Triple Negative Breast Cancer
A Phase 2 study, sponsored by Yuan Yuan.
- Not yet
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
NCT07552181 is a Phase 2 study that has not yet begun recruiting, run by Yuan Yuan. The registered enrollment target is 50 participants.
The verdict
NCT07552181, a Phase 2 study, has not yet begun recruiting, sponsored by Yuan Yuan.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
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.
Interventions
- DRUG Live biotherapeutic product: MO-03 1 capsule PO BID
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2026-09 |
| Est. Completion | 2035-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07552181
The ClinicalTrials.gov registry entry for NCT07552181 describes a study currently listed as not yet recruiting, categorized as Phase 2. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yuan Yuan, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Live biotherapeutic product: MO-03 1 capsule PO BID is the first listed.
NCT07552181 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07552181 about?
NCT07552181 is a clinical study titled "Phase II Trial of Pembrolizumab/Chemotherapy With Live Biotherapeutic Product MO-03 in Patients With Early Stage Triple Negative Breast Cancer". 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 sta...
What is the current status of trial NCT07552181?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2026-09. Estimated completion is 2035-09.
What interventions are being tested in trial NCT07552181?
The interventions under investigation include: Live biotherapeutic product: MO-03 1 capsule PO BID (DRUG).
Who is sponsoring clinical trial NCT07552181?
This trial is sponsored by Yuan Yuan, which has 3 total clinical trials registered on ClinicalTrials.gov.
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