Cancer SurvivorsPhase 2GIANTS-1NCT07363057
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
A Phase 2 study testing GI-102 in combination with GIB-7 in people with Cancer Survivors and Healthy Participant, run by GI Innovation, Inc. at 2 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer Survivors, Healthy Participant, Elderly
- What is being tested?
- GI-102 in combination with GIB-7
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 2 sitesAustralia
- Study dates
- Jan 2026to 1 Oct 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be aged between ≥18 and ≤80 years old at the time of informed consent.
- 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).
- Participants with a history of cancer may be included only if they meet one of the following:
- Participants have been disease-free for ≥2 years; OR
- For those diagnosed within 2 years:
- The cancer was treated with curative intent (eg, surgery, anti-cancer agents including chemotherapy)
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- 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
- 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).
Who cannot join
- 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).
- 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.
- Major surgery within the past 6 months or scheduled during the study period, including severe orthopedic diseases requiring joint replacement surgery.
- History of substance abuse or dependency or history of recreational IV drug use over the last 5 years (by self-declaration).
- Female participants who are pregnant, planning to become pregnant, or breastfeeding during the study period. Participants undergoing perimenopause or the menopause transition are eligible.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Karen Hwang contact
Australia2 sites, 2 recruiting
- Recruiting
Southern Oncology Clinical Research Unit
Adelaide, South Australia, 5042
Ganessan Kichenadasse, Dr., +61 491-679-039, GIANTS-1@gi-innovation.com
Ganessan Kichenadasse, Dr.
- Recruiting
Novatrials
Charlestown, New South Wales, 2290
Oscar Cumming, Dr., +61 02-4089-3744, GIANTS-1@gi-innovation.com
Oscar Cumming, Dr.
About this study
Official title: 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 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.
Read the 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
- Being tested
- GI-102 in combination with GIB-7, Placebo
- Keywords
- GI-102, GIB-7, aging, immunosenescence, gut-brain-muscle axis dysregulation, metabolic dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GI-102 in combination with GIB-7Combination product
Also called efzilonkofusp alfa 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)
PlaceboCombination product
Placebo for GI-102 in combination with GIB-7
| Study group | Role | What they receive |
|---|---|---|
| Part A | Active comparator | GI-102 in combination with GIB-7 Receives: Combination Product: GI-102 in combination with GIB-7 |
| Part B Arm 1 | Active comparator | GI-102 in combination with GIB-7 Receives: Combination Product: GI-102 in combination with GIB-7 |
| Part B Arm 2 | Placebo comparator | Placebo for GI-102 in combination with GIB-7 Receives: Combination Product: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: From Day 1 until Week 10 visit
Secondary outcomes (4)
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
Measured: 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
Change from Baseline values in quality of life using EQ-5D (EuroQol 5 Dimension) at Week 8 and Week 10
Measured: 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
Measured: 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
Measured: From enrollment to the end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionMay 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer SurvivorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GI Innovation, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GILongevity
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07363057
- Sponsor's protocol ID
- GIANTS-1
- Acronym
- GIANTS-1
- Status last verified
- Jan 2026
- First submitted
- 2 Dec 2025
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data and biospecimens collected in this study may be accessed by the XPRIZE Foundation and its designated Judging Panel solely for the purpose of verifying study results and evaluating eligibility for the XPRIZE Healthspan Competition. No identifiable personal information will be shared, and all data provided will remain confidential and used only for competition judging and audit purposes.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07363057
- Acronym / sponsor ID
- GIANTS-1 / GIANTS-1
- Conditions
- Cancer Survivors, Healthy Participant, Elderly
- Keywords
- GI-102, GIB-7, aging, immunosenescence, gut-brain-muscle axis dysregulation, metabolic dysfunction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- GI Innovation, Inc.Industry (pharma, biotech, devices)
- Collaborators
- GILongevity
- Study start
- Jan 2026 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A | Active comparator | Combination Product: GI-102 in combination with GIB-7GI-102 in combination with GIB-7 |
| Part B Arm 1 | Active comparator | Combination Product: GI-102 in combination with GIB-7GI-102 in combination with GIB-7 |
| Part B Arm 2 | Placebo comparator | Combination Product: PlaceboPlacebo for GI-102 in combination with GIB-7 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Must be aged between ≥18 and ≤80 years old at the time of informed consent.
- 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).
- Participants with a history of cancer may be included only if they meet one of the following:
- 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 (5 listed)
- 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).
- 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.
- Major surgery within the past 6 months or scheduled during the study period, including severe orthopedic diseases requiring joint replacement surgery.
- History of substance abuse or dependency or history of recreational IV drug use over the last 5 years (by self-declaration).
- Female participants who are pregnant, planning to become pregnant, or breastfeeding during the study period. Participants undergoing perimenopause or the menopause transition are eligible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GI-102 in combination with GIB-7Also: efzilonkofusp alfa in combination with GIB-7GI-102: recombinant protein drug, intravenous (IV) infusion, once every 4 weeks (Q4W); GIB-7: synbiotic formula, oral administration, once daily (QD) | Combination product | Part A, Part B Arm 1 |
| PlaceboPlacebo for GI-102 in combination with GIB-7 | Combination product | Part B Arm 2 |
Primary outcome
Change in Baseline values in immune response (NK cells) before and after GI-102 and GIB-7 combination treatment
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
4 secondary outcomes
Change in Baseline values in sleep quality before and after GI-102 and GIB-7 combination treatment
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
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
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
Time frame: From enrollment to the end of study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: Yes. Data and biospecimens collected in this study may be accessed by the XPRIZE Foundation and its designated Judging Panel solely for the purpose of verifying study results and evaluating eligibility for the XPRIZE Healthspan Competition. No identifiable personal information will be shared, and all data provided will remain confidential and used only for competition judging and audit purposes.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karen Hwang contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GI-102 in combination with GIB-7 in people with Cancer Survivors and Healthy Participant, run by GI Innovation, Inc. at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wayne Lee, Ph.D., MBA (+82-2-404-2003, woohyung.wayne.lee@gi-innovation.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Baseline values in immune response (NK cells) before and after GI-102 and GIB-7 combination treatment (time frame: From Day 1 until Week 10 visit). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.