Clinical Trials

Tucatinib (ONT-380)

A small molecule selective inhibitor of HER2, a growth factor receptor that is over-expressed in multiple cancers, including breast, ovarian, and stomach cancer.
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Tucatinib (ONT-380)

The following clinical trial is currently open for enrollment:

Phase 2 Randomized, Double-Blinded, Controlled Study of Tucatinib vs Placebo in Combination With Capecitabine and Trastuzumab in Patients With Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Carcinoma

This clinical trial is a Phase 2 randomized, double-blinded, placebo-controlled study of tucatinib in combination with Herceptin and Xeloda in patients with pretreated, unresectable locally advanced or metastatic HER2-positive breast cancer. (ClinicalTrials.gov Identifier: NCT02614794)

Patients must have been previously treated with a taxane, Herceptin, Perjeta (pertuzumab) and Kadcyla (ado-trastuzumab emtansine or T-DM1). Patients with or without brain metastases are eligible, including patients with asymptomatic untreated brain metastases not needing immediate local therapy and patients with previously treated brain metastases.

The trial's objectives are to assess the efficacy, safety and pharmacokinetics of tucatinib in combination with Herceptin and Xeloda. The primary endpoint is progression free survival (PFS) based on assessment of both CNS and non-CNS disease. Additional endpoints include time to CNS progression, objective response rate and overall survival. The trial is expected to enroll approximately 180 patients in multiple centers located in the United States, Canada and Western Europe.

For more information, please visit clinicaltrials.gov.

Our Pipeline Targets Large Cancer Indications
Read More >
Dedicated to Improving the Treatment of Cancer
Read More >