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Safety and Tolerability Study of GIM-122 in Subjects With Advanced Solid Malignancies
NCT06028074 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG GIM122
Study Locations (11)
California
- The Angeles Clinic and Research Institute — Los Angeles
- USC/Norris Comprehensive Cancer Center — Los Angeles
- UCLA Hematology/Oncology — Los Angeles
- UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco
Texas
- Texas Oncology - Baylor Sammons Cancer Center — Dallas
- NEXT Oncology Dallas — Irving
Florida
- Florida Cancer Specialists — Sarasota
Kentucky
- Norton Cancer Institute — Louisville
New Jersey
- Rutgers Cancer Institute of NJ — New Brunswick
Tennessee
- Tennessee Oncology, PLLC — Nashville
Virginia
- Virginia Commonwealth University — Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 111 participants |
| Start Date | 2023-12-12 |
| Est. Completion | 2026-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06028074
The ClinicalTrials.gov registry entry for NCT06028074 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 111 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Georgiamune, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Advanced Solid Malignancies appearing as the primary indexed condition, and to 1 intervention — of which GIM122 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06028074 reports 11 study locations spanning 7 distinct geographic areas — top geographies include California, Texas, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06028074 about?
NCT06028074 is a clinical study titled "Safety and Tolerability Study of GIM-122 in Subjects With Advanced Solid Malignancies". 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.
What is the current status of trial NCT06028074?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 111 participants. The study started on 2023-12-12. Estimated completion is 2026-12.
What conditions does trial NCT06028074 study?
This clinical trial studies the following conditions: Advanced Solid Malignancies. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06028074?
The interventions under investigation include: GIM122 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06028074?
This trial is sponsored by Georgiamune, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06028074 being conducted?
This trial has 11 study locations across California, Florida, Kentucky, New Jersey, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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