Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05354102 | A First-in-human (FIH) Combination Treatment Study With a Single Dose Level of BMC128 | PHASE1 | ACTIVE NOT_RECRUITING | 11 | — | — | May 1, 2022 | Nov 1, 2025 | May 7, 2024 | 1 | Israel |
Safety and tolerability assessments will be based on frequency, severity, and duration of treatment-related AEs, including clinically significant changes from baseline in physical examination findings, vital signs, ECOG, and safety laboratory tests. All treatment-emergent adverse events (TEAEs) will be graded using NCI Common Terminology Criteria for Adverse Events 5.0 (CTCAE 5.0 or higher).
| Arm | Type | Description |
|---|---|---|
| BMC128 in combination with Nivolumab | EXPERIMENTAL | Four 28-day treatment cycles of the standard Nivolumab treatment protocol (480 mg on Day 1 of each cycle) together with a QD regimen of BMC128, followed by a Iong-term Nivolumab monotherapy. Prior to starting this combination treatment, patients will undergo: I. Native microbiota depletion stage - patients will be treated with oral Vancomycin 500mg in combination with Neomycin 1000mg, q6h for 72 hours. II. BMC128 monotherapy induction stage - One BMC128 capsule will be administered once daily QD for a period of 14 days. |
| Name | Type | Description |
|---|---|---|
| BMC128 | DRUG | A live bio-therapeutic product composed of 4 commensal bacterial strains, natural inhabitants of the human intestinal tract. |
| Nivolumab | DRUG | A human monoclonal antibody that blocks programmed-death-1 (PD-1). It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. |
Inclusion Criteria: 1. Capable of providing signed informed consent to participate in the study, and to comply with the requirements and restrictions listed in the protocol. 2. ≥18 years of age at time of informed consent 3. Histologically or cytologically confirmed metastatic or locally advanced u...