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Study of the Monoclonal Antibody IMT-009 in Patients With Advanced Solid Tumors or Lymphomas
NCT05565417 · View on ClinicalTrials.gov ↗
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 |
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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. 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 67 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Immunitas Therapeutics, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 10 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 2 interventions — of which IMT-009 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: NCT05565417 reports 9 study locations spanning 8 distinct geographic areas — top geographies include Florida, Arizona, Colorado. 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 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: Colorectal Cancer, Non Small Cell Lung Cancer, Esophageal Cancer, Head and Neck Squamous Cell Carcinoma, Triple Negative Breast Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05565417?
The interventions under investigation include: IMT-009 (DRUG), Fruquintinib (COMBINATION_PRODUCT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05565417?
This trial is sponsored by Immunitas Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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