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 | Recruiting Phase 2 DMC

• 1 other identifier: GIANTS-1
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Cancer Survivors; Healthy Participant; Elderly

Keywords

GI-102; GIB-7; aging; immunosenescence; gut-brain-muscle axis dysregulation; metabolic dysfunction

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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

  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

  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

  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

  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

  From enrollment to the end of study

Other Outcomes (5)

• Change in Baseline values in the hospital visits by GI-102 and GIB-7 combination treatment

  From Day 1 until Week 10 visit

• Change in Baseline values in gut microbiome by GI-102 and GIB-7 combination treatment

  From Day 1 until Week 10 visit

• Change in Baseline values in cognitive function by GI-102 and GIB-7 combination treatment

  From Day 1 until Week 10 visit

Study Arms (3)

Part A

ACTIVE COMPARATOR

GI-102 in combination with GIB-7

Combination Product: GI-102 in combination with GIB-7

Part B Arm 1

ACTIVE COMPARATOR

GI-102 in combination with GIB-7

Combination Product: GI-102 in combination with GIB-7

Part B Arm 2

PLACEBO COMPARATOR

Placebo for GI-102 in combination with GIB-7

Combination Product: Placebo

Interventions

GI-102 in combination with GIB-7 COMBINATION_PRODUCT

GI-102: recombinant protein drug, intravenous (IV) infusion, once every 4 weeks (Q4W); GIB-7: synbiotic formula, oral administration, once daily (QD)

Also known as: efzilonkofusp alfa in combination with GIB-7

Part A; Part B Arm 1

Placebo COMBINATION_PRODUCT

Placebo for GI-102 in combination with GIB-7

Part B Arm 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• GI Innovation, Inc.: lead
• GILongevity: collaborator

Study Sites (2)

Novatrials

Charlestown, New South Wales, 2290, Australia

RECRUITING

Southern Oncology Clinical Research Unit

Adelaide, South Australia, 5042, Australia

RECRUITING

Central Study Contacts

Wayne Lee, Ph.D., MBA

CONTACT

+82-2-404-2003; woohyung.wayne.lee@gi-innovation.com

Karen Hwang

CONTACT

+82-2-404-2003

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: January 23, 2026
• Study Start: January 1, 2026
• Primary Completion: May 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

AU (2)