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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
GI-102: recombinant protein drug, intravenous (IV) infusion, once every 4 weeks (Q4W); GIB-7: synbiotic formula, oral administration, once daily (QD)
Placebo for GI-102 in combination with GIB-7
Novatrials
Charlestown, New South Wales, Australia
RECRUITINGSouthern Oncology Clinical Research Unit
Adelaide, South Australia, Australia
RECRUITINGChange in Baseline values in immune response (NK cells) before and after GI-102 and GIB-7 combination treatment
Maximum change from Baseline values in immune function, primarily in natural killer (NK) cells assessed by flow cytometry in blood samples.
Time frame: From Day 1 until Week 10 visit
Change in Baseline values in immune response (CD8+ T cells) before and after GI-102 and GIB-7 combination treatment
Maximum change from Baseline values in immune function, primarily in CD8⁺ T cells assessed by flow cytometry in blood samples.
Time frame: From Day 1 until Week 10 visit
Frequency of Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) of the combination of GI-102 and GIB-7 by severity
Frequency of Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) by severity.
Time frame: From Day 1 until Week 10 visit
Number of participants with various adverse events and abnormal lab data
Number of participants with Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), abnormal Vital signs, abnormal Electrocardiograms (ECGs), abnormal Physical examination findings, abnormal Chest X-ray, or abnormal Laboratory tests results
Time frame: From Day 1 until Week 10 visit
Change in Baseline values in sleep quality before and after GI-102 and GIB-7 combination treatment
Change from Baseline values in sleep quality using ISI (Insomnia Severity Index) at Week 8 and Week 10
Time frame: From Day 1 until Week 10 visit
Change in Baseline values in quality of life before and after GI-102 and GIB-7 combination treatment
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Purpose
TREATMENT
Masking
SINGLE
Enrollment
15
Change from Baseline values in quality of life using EQ-5D (EuroQol 5 Dimension) at Week 8 and Week 10
Time frame: From Day 1 until Week 10 visit
Change in Baseline values in muscle function (hand grip strength) before and after GI-102 and GIB-7 combination treatment
Change from Baseline values in muscle function using hand grip strength test at Week 8 and Week 10
Time frame: From enrollment to the end of study
Change in Baseline values in muscle function (6 minute walk test) before and after GI-102 and GIB-7 combination treatment
Change from Baseline values in muscle function using 6 minute walk test at Week 8 and Week 10
Time frame: From enrollment to the end of study