Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 2:02 AM
Study NCT ID:
NCT07363057
Status:
RECRUITING
Last Update Posted:
2026-01-26
First Post:
2025-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Effects of the Combination of GI-102 With GIB-7 on Biomarkers of Aging in Healthy Adults and Cancer Survivors
Sponsor:
GI Innovation, Inc.
Organization:
Study Overview
Official Title:
Phase 2a, Proof-Of-Concept, Multi-National, 8-Week, Randomized, Single-Blinded, Placebo-Controlled Trial of GI-102 in Combination With GIB-7 to Evaluate Its Effects on Biomarkers of Aging in Healthy Adults and Cancer Survivors
Status:
RECRUITING
Status Verified Date:
2026-01
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:
GIANTS-1
Brief Summary:
This Phase 2a clinical study (GIANTS-1) aims to evaluate a novel dual-combination strategy using GI-102 and GIB-7 to address key pathological features of aging, including immunosenescence (the aging of the immune system), metabolic dysfunction, and gut-brain-muscle axis dysregulation.
Detailed Description:
GI-102 targets immunosenescence and inflammation: GI-102 is a bispecific immunocytokine composed of CD80 fused with a mutated interleukin (IL)-2. It is currently being evaluated in an ongoing Phase 2 oncology study, in which its safety and tolerability has been evaluated. Clinically meaningful biological activity-such as increased peripheral lymphocyte counts (including CD8+ T cells and natural killer \[NK\] cells)-has been observed, supporting its potential role in immune reactivation and inflammation modulation in the aging population.
GIB-7 restores gut-brain-muscle axis and circadian rhythm: GIB-7 is a proprietary synbiotic formulation that contains four probiotic strains- Limosilactobacillus fermentum, Lactiplantibacillus plantarum, which are gram-positive lactic acid bacteria. Additionally, it contains the strains Lactobacillus acidophilus, and Bifidobacterium animalis subsp. lactis. These components collectively support gut microbial stability and systemic physiological balance. In a clinical study conducted in healthy older adults (NCT05735418), GIB-7 demonstrated significant improvements in grip strength and reductions in inflammatory markers, with no investigational product (IP)-related adverse events (AEs), confirming its excellent safety profile. Additionally, GIB-7 has been shown to support circadian rhythm regulation, a key aspect of homeostatic aging that is often disrupted in older adults.
The rationale for combining these two agents is their complementary mechanisms:
* GI-102 aims to remove senescent cells and thereby reduce inflammaging (a form of low-grade inflammation associated with ageing) via immune reactivation.
* GIB-7 aims to enhance gut stability and support the gut-brain-muscle axis and circadian alignment, thereby improving physical and cognitive resilience.
This dual-combination strategy addresses complementary hallmarks of aging, offering a mechanistically integrated approach to extending healthspan (the period during which individuals remain functional and free of chronic diseases) in healthy adults and cancer survivors.
GIB-7 restores gut-brain-muscle axis and circadian rhythm: GIB-7 is a proprietary synbiotic formulation that contains four probiotic strains- Limosilactobacillus fermentum, Lactiplantibacillus plantarum, which are gram-positive lactic acid bacteria. Additionally, it contains the strains Lactobacillus acidophilus, and Bifidobacterium animalis subsp. lactis. These components collectively support gut microbial stability and systemic physiological balance. In a clinical study conducted in healthy older adults (NCT05735418), GIB-7 demonstrated significant improvements in grip strength and reductions in inflammatory markers, with no investigational product (IP)-related adverse events (AEs), confirming its excellent safety profile. Additionally, GIB-7 has been shown to support circadian rhythm regulation, a key aspect of homeostatic aging that is often disrupted in older adults.
The rationale for combining these two agents is their complementary mechanisms:
* GI-102 aims to remove senescent cells and thereby reduce inflammaging (a form of low-grade inflammation associated with ageing) via immune reactivation.
* GIB-7 aims to enhance gut stability and support the gut-brain-muscle axis and circadian alignment, thereby improving physical and cognitive resilience.
This dual-combination strategy addresses complementary hallmarks of aging, offering a mechanistically integrated approach to extending healthspan (the period during which individuals remain functional and free of chronic diseases) in healthy adults and cancer survivors.
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?: