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

Running, not enrolling · Phase 2

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

In brief

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.

Key facts

Study ID

NCT04639219

Run by

AstraZeneca

People needed

102

Starts

2020-12-30

Expected to finish

2026-07-14

Last updated by the study team

2026-03-23

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Research Site — Santa Rosa, California, United States
• Research Site — Muncie, Indiana, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Middletown, New Jersey, United States
• Research Site — Commack, New York, United States
• Research Site — Harrison, New York, United States
• Research Site — New York, New York, United States
• Research Site — Houston, Texas, United States
• Research Site — Fairfax, Virginia, United States
• Research Site — Anderlecht, Belgium
• Research Site — Toronto, CA, Canada
• 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

Full record on ClinicalTrials.gov

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