Tucatinib + Trastuzumab for HER2-Positive Cancers

Recruiting at 73 trial locations

Overseen By Seagen Trial Information Support

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Seagen, a wholly owned subsidiary of Pfizer

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial studies how well tucatinib works for solid tumors that make either more HER2 or a different type of HER2 than usual (HER2 alterations) The solid tumors studied in this trial have either spread to other parts of the body (metastatic) or cannot be removed completely with surgery (unresectable). All participants will get both tucatinib and trastuzumab. People with hormone-receptor positive breast cancer will also get a drug called fulvestrant. The trial will also look at what side effects happen. A side effect is anything a drug does besides treating cancer.

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

This trial is for adults with advanced solid tumors that have HER2 alterations and have worsened after treatment, or can't be surgically removed. They must have an ECOG performance status of 0 or 1 (fully active or restricted in physically strenuous activity but ambulatory), measurable disease, and specific types of non-small cell lung cancer (NSCLC). Those with certain breast cancers are excluded, as well as anyone previously treated with HER2-targeted therapy unless specified.

Inclusion Criteria

My condition worsened or I couldn't tolerate my last cancer treatment.

My non-squamous NSCLC has worsened despite treatment or lacks a standard treatment option.

My cancer has worsened after at least one treatment for advanced or metastatic disease.

Exclusion Criteria

I have been exposed to high doses of specific chemotherapy drugs.

I have had HER2 therapy before, except for specific cancers treated with trastuzumab.

My cancer is HER2 positive.

Treatment Details

Interventions

• Fulvestrant (Estrogen Receptor Antagonist)
• Trastuzumab (Monoclonal Antibody)
• Tucatinib (Small Molecule Kinase Inhibitor)

Trial Overview The study tests the effectiveness of tucatinib combined with trastuzumab on various solid tumors with abnormal HER2 production. Patients with hormone-receptor positive breast cancer will also receive fulvestrant. The goal is to see how these drugs work together against different tumor types that are either metastatic or unresectable.

Participant Groups

Group I: Tucatinib + Trastuzumab (+ Fulvestrant) Experimental Treatment 3 Interventions

Tucatinib + trastuzumab (+ fulvestrant in hormone-receptor positive HER2-mutant breast cancer only)

Fulvestrant is already approved in Canada, Japan for the following indications:

Approved in Canada as Faslodex for:

• Hormone receptor-positive metastatic breast cancer
• Locally advanced breast cancer

Approved in Japan as Faslodex for:

• Hormone receptor-positive metastatic breast cancer
• Locally advanced breast cancer

Who Is Running the Clinical Trial?

Seagen, a wholly owned subsidiary of Pfizer

Lead Sponsor

Trials

20

Recruited

4,900+

Seagen Inc.

Lead Sponsor

Trials

212

Recruited

73,800+

Founded

1997

Headquarters

Bothell, USA

Known For

Antibody-Drug Conjugates

Top Products

Adcetris (brentuximab vedotin), Tukysa (tucatinib), Padcev (enfortumab vedotin-ejfv), Tivdak (tisotumab vedotin-tftv)

Dr. Roger Dansey

Seagen Inc.

Chief Medical Officer since 2018

MD from University of Witwatersrand

David R. Epstein

Seagen Inc.

Chief Executive Officer since 2022

BSc in Pharmacy from Rutgers University, MBA from Columbia University