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NCT05565417 · ClinicalTrials.gov registry record · Phase 1
Study of the Monoclonal Antibody IMT-009 in Patients With Advanced Solid Tumors or Lymphomas
A Phase 1 study of Non-Small Cell Lung Cancer and Colorectal Cancer, sponsored by Immunitas Therapeutics.
- Active
- Registry status
- Phase 1
- Development phase
- 67
- Enrollment target
- 9
- Study locations
NCT05565417 is a Phase 1 study of Non-Small Cell Lung Cancer and Colorectal Cancer that is active but no longer recruiting, run by Immunitas Therapeutics. The registered enrollment target is 67 participants, below the 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (90% lower). The trial reports 9 study locations across 8 states.
The verdict
NCT05565417, a Phase 1 study of Non-Small Cell Lung Cancer and Colorectal Cancer, is active but no longer recruiting, sponsored by Immunitas Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 67 participants
- Enrollment target
- 9
- Study locations
Study Summary
This is a Phase 1/2a open-label, multicenter, dose escalation and dose expansion trial in which IMT-009 will be administered by the intravenous (IV) route to participants with solid tumors or lymphomas. The main goals of this study are to: * Find the recommended dose of IMT-009 that can be safely given to participants * Learn more about the side effects of IMT-009 * Learn more about pharmacokinetics of IMT-009 * Learn more about the effectiveness of IMT-009 * Learn more about different pharmacokinetic biomarkers and how they might change in the presence of IMT-009
Conditions Studied
Interventions
- DRUG IMT-009
- COMBINATION_PRODUCT Fruquintinib
Study Locations (9)
Florida
- Site 4100 - Orlando
- Site 4060 - Sarasota
Arizona
- Site 9618 - Tucson
Colorado
- Site 5000 - Denver
Oklahoma
- Site 4500 - Oklahoma City
Oregon
- Site 9280 - Portland
Tennessee
- Site 3000 - Nashville
Texas
- Site 9384 - Austin
Virginia
- Site 9112 - Fairfax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2022-11-28 |
| Est. Completion | 2026-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05565417
The ClinicalTrials.gov registry entry for NCT05565417 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 67 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (90% lower). The listed sponsor is Immunitas Therapeutics, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which IMT-009 is the first listed.
NCT05565417 reports 9 study locations spanning 8 distinct geographic areas - top geographies include Florida, Arizona, Colorado.
Frequently Asked Questions
What is clinical trial NCT05565417 about?
NCT05565417 is a clinical study titled "Study of the Monoclonal Antibody IMT-009 in Patients With Advanced Solid Tumors or Lymphomas". This is a Phase 1/2a open-label, multicenter, dose escalation and dose expansion trial in which IMT-009 will be administered by the intravenous (IV) route to participants with solid tumors or lymphomas. The main goals of this study are to: * Find the recommended dose of IMT-009 that can be safely ...
What is the current status of trial NCT05565417?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 67 participants. The study started on 2022-11-28. Estimated completion is 2026-01.
What conditions does trial NCT05565417 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Colorectal Cancer, Esophageal Cancer, Head and Neck Squamous Cell Carcinoma, Triple Negative Breast Cancer.
What interventions are being tested in trial NCT05565417?
The interventions under investigation include: IMT-009 (DRUG), Fruquintinib (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT05565417?
This trial is sponsored by Immunitas Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05565417 being conducted?
This trial has 9 study locations across Arizona, Colorado, Florida, Oklahoma, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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