Ireland
--:--IST
Active, not recruiting Phase 2

A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating Mutations

NCT04639219 · tracked via the Priya Life Science Italy tracker
Phase
Phase 2
Started
2020-12-30
Last updated
2026-03-23

Condition(s) studied

Advanced Solid Tumors With HER2 Mutation,eg:Colorectal,Urothelial,Gastric, Hepatobiliary,Endometrial,Melanoma,Ovarian,Cervical,Salivary Gland,Pancreatic,Breast

Investigational drug(s) / intervention(s)

Trastuzumab deruxtecan →

Trastuzumab deruxtecan: Trastuzumab deruxtecan (T-DXd) by intravenous infusion

Study summary

This is an open-label, multi-center, single arm, Phase II study to evaluate the efficacy and safety of T-DXd for the treatment of unresectable and/or metastatic solid tumors harboring specific HER2 activating mutations regardless of tumor histology. The target population are patients who have progressed following prior treatment or who have no satisfactory alternative treatment options, including approved second line therapies in the specific tumor type. Pre-specified HER2 mutations will be locally assessed using NGS tests or alternative methods. Prior HER2 targeting therapy is permitted.

Eligibility

Sex
ALL
Min age
18 Years
Max age
120 Years
Healthy volunteers
No
Inclusion Criteria: * Adults ≥18 years old. Other age restrictions may apply as per local regulations. * Unresectable and/or metastatic solid tumors with pre-specified HER2 mutations (S310F, S310Y, G660D, R678Q, D769Y, D769H, V777L, Y772\_A775dup / A775\_G776insYVMA, L755S, G778\_P780dup / P780\_Y781insGSP, T862A, and V842I locally determined by NGS or a validated nucleic acid-based methodology (eg, qPCR, digital PCR) on tumor tissue, who have progressed following prior treatment or who have no satisfactory alternative treatment options. * Prior HER2 targeted therapy is permitted. * All patients must provide an FFPE tumor sample for retrospective central HER2 testing. * LVEF ≥50% * ECOG 0-1 * All patients have measurable target disease assessed by the Investigator based on RECIST v1.1 Exclusion Criteria: * HER2 overexpressing (IHC3+ or IHC2+/ISH+) breast, gastric or gastroesophageal junction adenocarcinoma. * HER2 mutant NSCLC. * Medical history of myocardial infarction within 6 months before randomization/enrolment, symptomatic CHF, unstable angina pectoris, clinically important cardiac arrhythmias, or a recent (\< 6 months) cardiovascular event including stroke. * History of non-infectious pneumonitis/ILD, current ILD, or where suspected ILD cannot be ruled out by imaging at screening * Corrected QT interval by Fridericia's formula (QTcF) prolongation to \> 470 msec (females) or \> 450 msec (males) based on average of the screening triplicate 12-lead ECG. * Lung-specific intercurrent clinically significant severe illnesses. * History of active primary immunodeficiency, known HIV, active HBV or HCV infection * Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals * Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART). * Has spinal cord compression or clinically active central nervous system metastases.

Primary outcome measure(s)

  • Confirmed Overall Response Rate (ORR) as Per RECIST v1.1 Using Independent Central Review (ICR) — Tumor scans performed at screening,then every 6 weeks (q6w) +/- 1 week relative to date of first treatment administration until RECIST v1.1 objective PD, withdrawal of consent, or death by any cause, up to DCO date of 25 Jan 2023 (approximately 24 months)
    Confirmed ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR), as determined by ICR per RECIST v1.1. A CR was defined as disappearance of all target lesions (TLs) and PR was defined as at least a 30% decrease in the sum of the diameters (dms) of TL, taking as reference the baseline sum of diameters as long as criteria for PD were not met. An ICR of all radiological imaging data was carried out using RECIST v1.1. All images were collected centrally. The imaging scans were reviewed by 2 independent radiologists and were adjudicated, if required.

Trial sites (30)

FacilityCityRegionStatus
Research Site Santa Rosa California
Research Site Muncie Indiana
Research Site Boston Massachusetts
Research Site Boston Massachusetts
Research Site Middletown New Jersey
Research Site Commack New York
Research Site Harrison New York
Research Site New York New York
Research Site Houston Texas
Research Site Fairfax Virginia
Research Site Anderlecht Belgium
Research Site Toronto CA
Research Site Copenhagen Denmark
Research Site Bordeaux France
Research Site Lyon France
Research Site Villejuif France
Research Site Milan Italy
Research Site Milan Italy
Research Site Naples Italy
Research Site Chūōku Japan
Research Site Kashiwa Japan
Research Site Suita-shi Japan
Research Site Seoul South Korea
Research Site Seoul South Korea
Research Site Seoul South Korea
Research Site Barcelona Spain
Research Site Madrid Spain
Research Site Madrid Spain
Research Site Pamplona Spain
Research Site Seville Spain
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04639219 on ClinicalTrials.gov ↗ ← All trials in Italy