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NCT06028074 · ClinicalTrials.gov registry record · Phase 1
Safety and Tolerability Study of GIM-122 in Subjects With Advanced Solid Malignancies
A Phase 1 study of Advanced Solid Malignancies, sponsored by Georgiamune.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 111
- Enrollment target
- 11
- Study locations
NCT06028074: Recruiting Phase 1 study of Advanced Solid Malignancies, sponsored by Georgiamune.
NCT06028074 is a Phase 1 study of Advanced Solid Malignancies that is actively recruiting participants, run by Georgiamune. The registered enrollment target is 111 participants, below the 227-participant average among 6 other Advanced Solid Malignancies trials with a reported enrollment target (51% lower). The trial reports 11 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06028074, a Phase 1 study of Advanced Solid Malignancies, is actively recruiting participants, sponsored by Georgiamune.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 111 participants
- Enrollment target
- 11
- Study locations
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.
Primary Outcome
To identify dose limiting toxicities \[DLT\] with GIM-122
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 |
What NCT06028074 shows while recruiting
NCT06028074 is an interventional study that assigns participants to a tested intervention. The registered 111 participants enrollment target is mid-sized for trials with a published cap, below the 227-participant average among 6 other Advanced Solid Malignancies trials with a reported enrollment target (51% lower).
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.
NCT06028074 lists 11 locations in 7 states (California, Texas, Florida).
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.
What interventions are being tested in trial NCT06028074?
The interventions under investigation include: GIM122 (DRUG).
Who is sponsoring clinical trial NCT06028074?
This trial is sponsored by Georgiamune, which has 2 total clinical trials registered on ClinicalTrials.gov.
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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