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

NCT05354102 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2024-05-07

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

BMC128

A live bio-therapeutic product composed of 4 commensal bacterial strains, natural inhabitants of the human intestinal tract.

DRUG

Nivolumab

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.

Sponsors & Collaborators

  • Biomica Ltd.

    lead INDUSTRY

Principal Investigators

  • Ruth Perets, Dr. · Rambam MC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-01
Primary Completion
2024-05-31
Completion
2025-11-30

Countries

  • Israel

Study Locations

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Entities

Drugs
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 NCT05354102 on ClinicalTrials.gov