GI-102 plus GIB-7 to target immune aging and gut‑brain‑muscle health
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
This trial tests whether combining GI-102 and the synbiotic GIB-7 can improve aging-related biomarkers in healthy adults and cancer survivors.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | GI Innovation, Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 2 sites (Charlestown, New South Wales and 1 other locations) |
| Trial ID | NCT07363057 on ClinicalTrials.gov |
What this trial studies
This Phase 2a interventional study gives participants either the GI-102 plus GIB-7 combination or placebo and measures a range of biological markers linked to aging. GI-102 is a bispecific immunocytokine designed to reactivate immune cells and lower inflammation, while GIB-7 is a synbiotic intended to support the gut‑brain‑muscle axis and circadian regulation. The study enrolls adults and cancer survivors who meet specific remission and treatment criteria and follows biomarker, immune cell, metabolic, and functional endpoints. Safety, tolerability, and changes in peripheral lymphocyte counts and inflammatory/metabolic markers are key outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults 18–80 years old who are generally healthy or cancer survivors meeting the protocol's remission/treatment requirements (for example disease‑free ≥2 years or in remission ≥12 months without prior immunotherapy).
Not a fit: Patients with active cancer, recent immunotherapy, severe life‑threatening illness, or those outside the 18–80 age range are unlikely to receive benefit from participation.
Why it matters
Potential benefit: If successful, the combination could boost immune cell counts, reduce inflammation, and improve muscle strength and circadian-related function in older adults and cancer survivors.
How similar studies have performed: GIB-7 showed improvements in grip strength and reduced inflammatory markers in a prior trial, and GI-102 has shown immune activation signals in oncology Phase 2 work, but the specific dual‑combination approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Charlestown, New South Wales and 1 other locations
- Novatrials — Charlestown, New South Wales, Australia (Recruiting)
- Southern Oncology Clinical Research Unit — Adelaide, South Australia, Australia (Recruiting)
Study contacts
- Study coordinator: Wayne Lee, Ph.D., MBA
- Email: woohyung.wayne.lee@gi-innovation.com
- Phone: +82-2-404-2003
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.