NCT04579380

Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations

A Phase 2 Basket Study of Tucatinib in Combination With Trastuzumab in Subjects With Previously Treated, Locally Advanced Unresectable or Metastatic Solid Tumors Driven by HER2 Alterations

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 217 (actual)
• Sponsor: Seagen, a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

There are multiple cohorts in this trial: * 5 tumor specific cohorts with HER2 overexpression/amplification (cervical cancer, uterine cancer, biliary tract cancer, urothelial cancer, and non-squamous non-small cell lung cancer \[NSCLC\]) * 2 tumor specific cohorts with HER2 mutations (non-squamous NSCLC and breast cancer) * 2 cohorts which will enroll all other HER2 amplified/overexpressed solid tumor types (except breast cancer, gastric or gastroesophageal junction adenocarcinoma \[GEC\], and colorectal cancer \[CRC\]) or HER2-mutated solid tumor types.

Conditions

• Uterine Neoplasms
• Uterine Cervical Neoplasms
• Biliary Tract Neoplasms
• Urologic Neoplasms
• Carcinoma, Non-Small-Cell Lung
• HER2 Mutations Breast Neoplasms

Interventions

Type	Name	Description
DRUG	tucatinib	300 mg orally twice daily
DRUG	trastuzumab	Given into the vein (intravenously; IV). 8mg/kg IV on Cycle 1 Day 1, and 6mg/kg every 21 days starting on Cycle 2 Day 1
DRUG	fulvestrant	Given into the muscle (intramuscular; IM) once every 4 weeks starting from Cycle 1 Day 1, plus one dose on Cycle 1 Day 15. Only administered to participants with hormone-receptor positive breast cancer.

Timeline

• Start date: 2021-01-11
• Primary completion: 2023-11-01
• Completion: 2026-04-30
• First posted: 2020-10-08
• Last updated: 2025-12-19
• Results posted: 2024-11-13

Locations

106 sites across 8 countries: United States, Belgium, Germany, Italy, Japan, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study