NCT07363057

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: GI Innovation, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cancer Survivors
• Healthy Participant
• Elderly

Interventions

Type	Name	Description
COMBINATION_PRODUCT	GI-102 in combination with GIB-7	GI-102: recombinant protein drug, intravenous (IV) infusion, once every 4 weeks (Q4W); GIB-7: synbiotic formula, oral administration, once daily (QD)
COMBINATION_PRODUCT	Placebo	Placebo for GI-102 in combination with GIB-7

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-05-01
• Completion: 2026-10-01
• First posted: 2026-01-23
• Last updated: 2026-01-26

Locations

2 sites across 1 country: Australia