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

No results posted yet for this 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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05565417 on ClinicalTrials.gov