NCT05354102

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

A Phase 1, Open-label Study to Evaluate the Safety and Tolerability of BMC128 in Combination With Nivolumab in Patients With Non-small Cell Lung Cancer (NSCLC), Melanoma or Renal Cell Carcinoma (RCC)

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Biomica Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This phase 1, first-in-human, proof-of-concept, open-label, combination treatment study is designed to profile the safety and tolerability of BMC128 in combination with Nivolumab, its effect on the intestinal microbiome and the anti-tumor immune and inflammatory responses and its preliminary anti-tumor activity. A 14-day induction phase, in which patients will be treated with a single dose level of BMC128, will be initiated, followed by four 28-day treatment cycles of BMC128 in combination with Nivolumab. Thereafter, patients will be treated with Nivolumab as a monotherapy for up to 22 additional cycles, until disease progression (PD) or intolerable toxicity

Conditions

• Non-small Cell Lung Cancer
• Melanoma
• Renal Cell Carcinoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-05-01
• Primary completion: 2024-05-01
• Completion: 2025-11-01
• First posted: 2022-04-29
• Last updated: 2024-05-07

Locations

1 site across 1 country: Israel