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)

NCT05354102 Phase 1 ACTIVE_NOT_RECRUITING

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.

Details

Lead sponsor	Biomica Ltd.
Phase	Phase 1
Status	ACTIVE_NOT_RECRUITING
Enrolment	11
Start date	2022-05-01
Completion	2025-11

Conditions

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

Interventions

• BMC128
• Nivolumab

Primary outcomes

• Number and severity of drug-related treatment emergent adverse events (TEAEs) — Through study completion, an average of 1 year
  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).

Countries

Israel