A First-in-human (FIH) Combination Treatment Study With a Single Dose Level of BMC128

Sponsor
Biomica Ltd.
Study ID
NCT05354102
Phase
PHASE1
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

The purpose of this study is to assess the safety and tolerability of BMC128 in combination with nivolumab (a known immunotherapy) in order to investigate if administration of select elements of the intestinal microbiome may serve as a novel and effective means of improving the efficacy of anti-cancer immunotherapies.

Key Dates

Start date
May 1, 2022
Status verified
May 2024
Primary completion
May 31, 2024
Completion
Nov 30, 2025

Study Design

Enrollment
11 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: BMC128 in combination with Nivolumab
    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.

Primary Outcome Measure

Number and severity of drug-related treatment emergent adverse events (TEAEs) [ Time Frame: Through study completion, an average of 1 year ]

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