Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:44 AM
Study NCT ID:
NCT05354102
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-07
First Post:
2022-04-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A First-in-human (FIH) Combination Treatment Study With a Single Dose Level of BMC128
Sponsor:
Biomica Ltd.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: