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

Active Not RecruitingPhase 2

Sponsor: AstraZeneca

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

Interventions: Trastuzumab deruxtecan

Countries: United States, Belgium, Canada, Denmark, France, Italy, Japan, South Korea

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 overview

Sex: ALL

Age: 18 Years to 120 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (30)

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