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

Last updated: January 23, 2026
Sponsor: GI Innovation, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Aging

Treatment

Placebo

GI-102 in combination with GIB-7

Clinical Study ID

NCT07363057
GIANTS-1
  • Ages 18-80
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. Must be aged between ≥18 and ≤80 years old at the time of informed consent.

  2. At the discretion of the Investigator, must be in a state of general health that isnot severely compromised (ie, no life-threatening illness or disability).

  3. Participants with a history of cancer may be included only if they meet one of thefollowing:

  4. Participants have been disease-free for ≥2 years; OR

  5. For those diagnosed within 2 years:

  • The cancer was treated with curative intent (eg, surgery, anti-canceragents including chemotherapy)
  • Participants have been in remission for ≥12 months
  • Participants are not on any active cancer treatment except maintenancetherapies (eg, endocrine therapy or bisphosphonates)
  • Participants must have received systemic anti-cancer therapies withoutimmunotherapy for their cancers
  1. Women of childbearing potential (WOCBP; see definition in Section 5.3) must agree touse a highly effective method of contraception from 14 days prior to Visit 2 until 180 days after the last dose of study medication (GI-102 or GIB-7). Fertile men mustagree to use an acceptable method of contraception from 14 days prior to Visit 2until 90 days after the last dose of study medication (GI-102 or GIB-7).

Exclusion

Key Exclusion Criteria:

  1. Severe and poorly managed chronic diseases, such as advanced cardiovascular disease,kidney failure requiring transplant or dialysis, uncontrolled diabetes, detectablemalignancy (≤ 2 years), severe chronic obstructive pulmonary disease (COPD), oruntreatable, terminal cancer as judged by the Investigator or history of lifethreatening infection (eg, meningitis).

  2. Dependent on walkers or wheelchairs; severe difficulty or inability to performactivities of daily living independently or inability to perform study measuresrequired to test muscle function (an amputee is eligible if participants can walkwithout walkers or wheelchair) as judged by the Investigator.

  3. Major surgery within the past 6 months or scheduled during the study period,including severe orthopedic diseases requiring joint replacement surgery.

  4. History of substance abuse or dependency or history of recreational IV drug use overthe last 5 years (by self-declaration).

  5. Female participants who are pregnant, planning to become pregnant, or breastfeedingduring the study period. Participants undergoing perimenopause or the menopausetransition are eligible.

Study Design

Total Participants: 15
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
January 01, 2026
Estimated Completion Date:
October 01, 2026

Study 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.

Connect with a study center

  • Novatrials

    Charlestown 2171766, New South Wales 2155400 2290
    Australia

    Active - Recruiting

  • Southern Oncology Clinical Research Unit

    Adelaide 2078025, South Australia 2061327 5042
    Australia

    Active - Recruiting

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