Study of the Monoclonal Antibody IMT-009 in Patients With Advanced Solid Tumors or Lymphomas
NCT05565417 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 67
Last updated 2025-10-16
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
- Non Small Cell Lung Cancer
- Head and Neck Squamous Cell Carcinoma
- Triple Negative Breast Cancer
- Cutaneous Squamous Cell Carcinoma
- Hormone Receptor Positive Breast Carcinoma
- Small Bowel Cancer
- Esophageal Cancer
- Colorectal Cancer
- Diffuse Large B Cell Lymphoma
- Hodgkin Lymphoma
- Burkitt Lymphoma
- Follicular Lymphoma
Interventions
- DRUG
-
IMT-009
Participants will receive an IV infusion of IMT-009 on Day 1 during each 21-day cycle.
- COMBINATION_PRODUCT
-
Fruquintinib
Fruquintinib will be administered according to the FDA-approved United States Prescribing Information (USPI).
Sponsors & Collaborators
-
Immunitas Therapeutics
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-11-28
- Primary Completion
- 2026-01-31
- Completion
- 2026-01-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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