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TGW211 for Click-Cleavable Imaging in HER2-Positive Cancers.

NCT07009184 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2025-11-18

No results posted yet for this study

Summary

In recent years, there is increasing interest in antibodies for imaging, antibody-drug conjugates (ADC) and targeted radionuclide therapy (TRT). With these techniques, antibodies are used as a vector to deliver a cytotoxic drug or radionuclide for therapy or nuclear medicine imaging. One such antibody-based vector suitable for delivering a cytotoxic drug or radionuclide is trastuzumab, which targets HER2 that is overexpressed in cancers such as breast, gastric and gastroesophageal junction carcinomas. Unfortunately, antibodies generally have a very long circulation time (\>20-30 days) that often result in unfavorable background noise in the healthy organs in imaging or toxicity when trastuzumab is bound to a therapeutic radionuclide for radioimmunotherapy. There is thus a need to increase the speed of excretion of antibodies or release the antibody from its payload. Ideally, the clinician would like to appropriately time the elimination of radioactivity to achieve an optimal tumor to non-tumor ratio. To this aim, Tagworks Pharmaceuticals developed a new class of chemically cleavable radiolabeled conjugates that release the radiolabel on demand upon reaction with a small molecule "the trigger" (TRG001).

Conditions

  • HER2 Positive Solid Tumor

Interventions

DRUG

[111In]In-DOTA-TCO-trastuzumab

\[111In\]In-DOTA-TCO-trastuzumab is a chemically cleavable \[111In\]In-labeled trastuzumab conjugate that is administered first to the patient, it accumulates in HER2-positive tumors and internalizes in HER2-expressing tumor cells.

DRUG

Small molecule tetrazine trigger component

TRG001 is a small molecule tetrazine trigger that reacts with \[111In\]In-TGW211-DC in blood and extracellular space thus releasing a fast clearing \[111In\]In-DOTA containing fragment which is rapidly eliminated via the kidney. Because of its non-cell permeable nature, TRG001 does not reach \[111In\]In-TGW211-DC inside tumor cells and therefore the radioactivity inside tumor cells is retained by the tumor.

Sponsors & Collaborators

  • Tagworks Pharmaceuticals BV

    collaborator INDUSTRY

  • Radboud University Medical Center

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-10
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Netherlands

Study Locations

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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 NCT07009184 on ClinicalTrials.gov