Ireland
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Recruiting Phase 2

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

NCT07363057 · tracked via the Priya Life Science Australia tracker
Phase
Phase 2
Started
2026-01
Last updated
2026-01-26

Condition(s) studied

Cancer SurvivorsHealthy ParticipantElderly

Investigational drug(s) / intervention(s)

GI-102 in combination with GIB-7Placebo

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)

Placebo: Placebo for GI-102 in combination with GIB-7

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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
Accepted
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 is not 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 the following: 1. Participants have been disease-free for ≥2 years; OR 2. For those diagnosed within 2 years: * The cancer was treated with curative intent (eg, surgery, anti-cancer agents including chemotherapy) * Participants have been in remission for ≥12 months * Participants are not on any active cancer treatment except maintenance therapies (eg, endocrine therapy or bisphosphonates) * Participants must have received systemic anti-cancer therapies without immunotherapy for their cancers 4. Women of childbearing potential (WOCBP; see definition in Section 5.3) must agree to use 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 must agree to use an acceptable method of contraception from 14 days prior to Visit 2 until 90 days after the last dose of study medication (GI-102 or GIB-7). Key Exclusion Criteria: 1. Severe and poorly managed chronic diseases, such as advanced cardiovascular disease, kidney failure requiring transplant or dialysis, uncontrolled diabetes, detectable malignancy (≤ 2 years), severe chronic obstructive pulmonary disease (COPD), or untreatable, terminal cancer as judged by the Investigator or history of life threatening infection (eg, meningitis). 2. Dependent on walkers or wheelchairs; severe difficulty or inability to perform activities of daily living independently or inability to perform study measures required to test muscle function (an amputee is eligible if participants can walk without 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 over the last 5 years (by self-declaration). 5. Female participants who are pregnant, planning to become pregnant, or breastfeeding during the study period. Participants undergoing perimenopause or the menopause transition are eligible.

Primary outcome measure(s)

  • Change in Baseline values in immune response (NK cells) before and after GI-102 and GIB-7 combination treatment — From Day 1 until Week 10 visit
    Maximum change from Baseline values in immune function, primarily in natural killer (NK) cells assessed by flow cytometry in blood samples.
  • Change in Baseline values in immune response (CD8+ T cells) before and after GI-102 and GIB-7 combination treatment — From Day 1 until Week 10 visit
    Maximum change from Baseline values in immune function, primarily in CD8⁺ T cells assessed by flow cytometry in blood samples.
  • Frequency of Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) of the combination of GI-102 and GIB-7 by severity — From Day 1 until Week 10 visit
    Frequency of Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) by severity.
  • Number of participants with various adverse events and abnormal lab data — From Day 1 until Week 10 visit
    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

Trial sites (2)

FacilityCityRegionStatus
Novatrials Charlestown New South Wales Recruiting
Southern Oncology Clinical Research Unit Adelaide South Australia Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07363057 on ClinicalTrials.gov ↗ ← All trials in Australia