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Official title 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
ClinicalTrials.gov ID: NCT07363057
What this study is testing
What is GI-102 in combination with GIB-7?
GI-102 in combination with GIB-7 is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for cancer survivors.
Also referred to as efzilonkofusp alfa in combination with GIB-7.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80. Healthy volunteers may be eligible.
You may be able to join 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...
- 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:
You likely can't join if
- Severe and poorly managed chronic diseases, such as advanced cardiovascular disease, kidney failure requiring transplant or dialysis, uncontrolled...
- Dependent on walkers or wheelchairs; severe difficulty or inability to perform activities of daily living independently or inability to perform study...
- 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...
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Charlestown, New South Wales, Australia
- Adelaide, South Australia, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charlestown, New South Wales, Australia; Adelaide, South Australia, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.