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BMC128 · 1 trial · 3 indications
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...
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BMC128 is an investigational small molecule being developed for the treatment of non-small cell lung cancer (NSCLC). It is currently in Phase 1 clinical development, with an ongoing first-in-human study that also includes patients with melanoma and renal cell carcinoma.
BMC128 is a small molecule, but its specific molecular target has not been disclosed. The drug is being studied in biomarker-selected patients, suggesting it may act on a particular genetic or molecular pathway relevant to the cancers being investigated.
BMC128 is being developed by Evogene Ltd., a company traded on the NASDAQ under the ticker EVGN. The company is conducting a Phase 1 clinical trial of BMC128 in Israel.
BMC128 is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities, and is being evaluated in a first-in-human study for safety and tolerability.
BMC128 is being studied in a Phase 1 first-in-human trial with the identifier NCT05354102. This open-label, uncontrolled study is enrolling approximately 11 patients with non-small cell lung cancer, melanoma, or renal cell carcinoma, and is being conducted in Israel.
No alternative names for BMC128 have been disclosed. It is identified solely by its code name BMC128 in clinical trial registrations and company communications.