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Tests treatment safety and results for Advanced Solid Malignancies
Official title Safety and Tolerability Study of GIM-122 in Subjects With Advanced Solid Malignancies
ClinicalTrials.gov ID: NCT06028074
What this study is testing
What is GIM122?
GIM122 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced solid malignancies.
Also referred to as GIM-122.
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
- GIM-122 is a first-in-class, humanized immunoglobulin G1 kappa dual functioning monoclonal antibody (DFA). This phase 1 / 2 study plans to evaluate the safety, tolerability, pharmacokinetics and clinical efficacy of intravenous (IV) administration of GIM-122 in adults with advanced malignancies.
- 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 and older
You may be able to join if
- General
- Written informed consent
- ECOG performance status 0-1.
- Laboratory assessment 28 days prior to enrollment for assessment of acceptable cardiac, renal and hepatic functions
- Recommended Double methods of contraception 90-days post treatment Cancer Specific
You likely can't join if
- General
- Enrolled in any other treatment clinical trial, starting within 4 weeks of the first dose of GIM-122 and throughout the duration of the study, or is...
- Women who are pregnant or breastfeeding
- History of cardiac issues, pulmonary embolism, active and clinically significant bacterial, fungal, or viral infection ≤ 6 months prior to dosing
- Contraindications to the imaging assessments or other study procedures that people will undergo or any medical or social condition that, in the...
- Current second malignancy at other sites
See the full eligibility criteria
- General
- Written informed consent
- ECOG performance status 0-1.
- Laboratory assessment 28 days prior to enrollment for assessment of acceptable cardiac, renal and hepatic functions
- Recommended Double methods of contraception 90-days post treatment Cancer Specific
- Histologically or cytologically confirmed locally advanced/unresectable or metastatic solid tumor
- Received FDA approved treatment of PD-1 inhibitor or PD-L1 inhibitor for advance malignant tumors and have progressed/relapsed, are refractory, or intolerant
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1
- Had prior therapy with PD-1/PD-L1 inhibitors. Other checkpoint inhibitors (ie, CTLA4, LAG3) are permitted if they did not lead to treatment discontinuation
- No other lines of therapy that are available
- General
- Enrolled in any other treatment clinical trial, starting within 4 weeks of the first dose of GIM-122 and throughout the duration of the study, or is receiving other therapy directed at their malignancy
- Women who are pregnant or breastfeeding
- History of cardiac issues, pulmonary embolism, active and clinically significant bacterial, fungal, or viral infection ≤ 6 months prior to dosing
- Contraindications to the imaging assessments or other study procedures that people will undergo or any medical or social condition that, in the opinion of the investigator, might place a subject at an increased risk...
- Current second malignancy at other sites
- Leptomeningeal disease
- Spinal cord compression
- Symptomatic or new or enlarging central nervous system (CNS) metastases Treatment-specific Exclusion Criteria
- Ongoing toxicity \> Grade 1 from prior therapy according to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0
- Has undergone a major surgery \< 1 month prior to administration of GIM-122
- Has received radiation therapy within 2 weeks prior to administration of GIM-122
- Has undergone or is anticipated to undergo organ transplantation including allogeneic or autologous stem cell transplantation at any time
- Has received systemic anti-cancer therapy within 2 weeks and cytotoxic agents that have a major delayed toxicity within 4 weeks, of the first dose of GIM-122
- Prior treatment with other immune modulating agents within \< 4 weeks prior to the first dose of GIM-122.
- Has a diagnosis of immunodeficiency, either primary or acquired
- Has received treatment with systemic steroids or any form of immunosuppressive therapy within 14 days prior to administration of GIM-122
- Has active or prior history of autoimmune disease, including ulcerative colitis and Crohn's disease, or any condition that requires systemic steroids.
- Has a known severe intolerance to or hypersensitivity reactions to monoclonal antibodies, Fc-bearing proteins, or IV immunoglobulin preparations; prior history of human anti-human antibody response; known allergy to any...
- Has received live vaccines within 30 days of study initiation (inactivated vaccines are allowed; seasonal vaccines should be up to date \> 30 days prior to administration of GIM-122).
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- San Francisco, California, United States
- Sarasota, Florida, United States
- Louisville, Kentucky, United States
- New Brunswick, New Jersey, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
- Irving, Texas, United States
- Richmond, Virginia, United States
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; San Francisco, California, United States; Sarasota, Florida, United States; Louisville, Kentucky, United States; New Brunswick, New Jersey, United States; Nashville, Tennessee, United States and 3 more location(s). 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.