Actively Recruiting
TGW211 for Click-Cleavable Imaging in HER2-Positive Cancers.
Led by Radboud University Medical Center · Updated on 2025-11-18
19
Participants Needed
1
Research Sites
50 weeks
Total Duration
On this page
Sponsors
R
Radboud University Medical Center
Lead Sponsor
T
Tagworks Pharmaceuticals BV
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
TGW211 for Click-Cleavable Imaging in HER2-Positive Cancers.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and able to follow study requirements
- Male or female aged 18 years or older
- Histologically confirmed HER2-positive cancer (IHC 3+ or IHC 2+ and FISH positive) with at least one measurable lesion of 10 mm or more on CT or MRI
- WHO performance status (ECOG) of 0 or 1
- Adequate organ and bone marrow function including: neutrophil count ≥ 1.5 x 10^9/l, platelet count ≥ 100 x 10^9/l, hemoglobin ≥ 9.0 g/dl, total bilirubin ≤ 1.5 x upper limit of normal, AST and ALT ≤ 3.0 x upper limit of normal (or ≤ 5.0 x with liver metastases), serum creatinine ≤ 1.5 x upper limit of normal, and estimated glomerular filtration rate ≥ 60 ml/min/1.73 m2
You will not qualify if you...
- History of myocardial infarction within 6 months or symptomatic congestive heart failure (NYHA Class III-IV)
- QTcF interval ≥ 470 msec on ECG or congenital long QT syndrome
- History of non-infectious interstitial lung disease or pneumonitis requiring steroids, or current/suspected ILD/pneumonitis
- Significant lung diseases such as recent pulmonary embolism, severe asthma, severe COPD, restrictive lung disease, or pleural effusion
- Uncontrolled infection needing systemic antibiotics, antivirals, or antifungals
- Participation in another investigational study within the past 6 weeks
- Concurrent enrollment in another clinical study unless observational or during follow-up period
- Pregnant or breastfeeding women
- Women of childbearing potential not using effective contraception or abstaining from sexual activity for 30 days after study drug
- Male patients of reproductive age not using condoms or abstaining from sexual activity for 30 days after study drug
- Known allergy or hypersensitivity to study drugs or excipients
- Any condition that investigator believes prevents study participation
- Presence of a second active cancer
AI-Screening
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Trial Site Locations
Total: 1 location
1
Radboud University Medical Center
Nijmegen, Gelderland, Netherlands, 6525 GS
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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