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Clinical Trials in Spain / NCT04579380
Active, not recruiting Phase 2

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

NCT04579380 · tracked via the Priya Life Science Spain tracker
Sponsor
Seagen, a wholly owned subsidiary of Pfizer
Phase
Phase 2
Started
2021-01-11
Last updated
2026-08-21

Condition(s) studied

Uterine NeoplasmsUterine Cervical NeoplasmsBiliary Tract NeoplasmsUrologic NeoplasmsCarcinoma, Non-Small-Cell LungHER2 Mutations Breast Neoplasms

Investigational drug(s) / intervention(s)

tucatinib →trastuzumab →fulvestrant →

tucatinib: 300 mg orally twice daily

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

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria * Histologically or cytologically confirmed diagnosis of locally-advanced unresectable or metastatic solid tumor, including primary brain tumors * Participants with non-squamous NSCLC must have progressed during or after standard treatment or for which no standard treatment is available * Participants with other disease types must have progressed during or after ≥1 prior line of systemic therapy for locally-advanced unresectable or metastatic disease * Disease progression during or after, or intolerance of, the most recent line of systemic therapy * Disease demonstrating HER2 alterations (overexpression/amplification or HER2 activating mutations), as determined by local or central testing processed in a Clinical Laboratory Improvement Amendments (CLIA)- or International Organization for Standardization (ISO) accredited laboratory, according to one of the following: * HER2 overexpression/amplification from fresh or archival tumor tissue or blood * Known activating HER2 mutations detected in fresh or archival tumor tissue or blood * Have measurable disease per RECIST v1.1 criteria according to investigator assessment * Have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Exclusion Criteria * Participants with breast cancer, gastric or gastroesophageal junction adenocarcinoma, or CRC whose disease shows HER2 amplification/overexpression. * Previous treatment with HER2-directed therapy; participants with uterine serous carcinoma or HER2-mutated gastric or gastroesophageal junction adenocarcinoma without HER2-overexpression/amplification may have received prior trastuzumab * Known hypersensitivity to any component of the drug formulation of tucatinib or trastuzumab (drug substance, excipients, murine proteins), or any component of the drug formulation of fulvestrant in participants with HR+ HER2-mutated breast cancer * History of exposure to a 360 mg/m² doxorubicin-equivalent or \>720 mg/m\^2 epirubicin-equivalent cumulative dose of anthracyclines * Treatment with any systemic anti-cancer therapy, radiation therapy, major surgery, or experimental agent within ≤3 weeks of first dose of study treatment or are currently participating in another interventional clinical trial. There are additional inclusion and exclusion criteria. The study center will determine if criteria for participation are met.

Primary outcome measure(s)

  • Confirmed Objective Response Rate (cORR) as Assessed by Investigator — From the first dose of study treatment until the first documented CR or PR on or before the first documented PD or new anti-cancer therapies or death, whichever occurred first (up to 28.3 months)
    Confirmed ORR was defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version (v)1.1 as assessed by investigator and was considered as confirmed when subsequent response was at least 4 weeks after initial response. As per RECIST v1.1, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 millimeter (mm). PR: at least a greater than or equal to (\>=)30 % decrease in the sum of diameters (SOD) of target lesions (longest for non-nodal target lesions and the short axes for nodal target lesions), taking as reference the baseline sum diameters. Disease progression (PD): at least \>=20% relative increase in SOD of target lesion taking as reference the smallest sum on study (including baseline sum if that is the smallest on study).

Trial sites (108)

FacilityCityRegionStatus
HonorHealth Phoenix Arizona
HonorHealth Tempe Arizona
The University of Arizona Cancer Center-North Campus Tucson Arizona
City of Hope at Huntington Beach Huntington Beach California
City of Hope at Irvine Sand Canyon Irvine California
Koman Family Outpatient Pavilion La Jolla California
UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion) La Jolla California
UC San Diego Moores Cancer Center- Investigational Drug Services La Jolla California
UC San Diego Moores Cancer Center La Jolla California
City of Hope at Long Beach Worsham Long Beach California
City of Hope at Long Beach Elm Long Beach California
City of Hope at Newport Beach Lido Newport Beach California
City of Hope Torrance Torrance California
Rocky Mountain Cancer Centers Aurora Colorado
Rocky Mountain Cancer Centers Boulder Colorado
Rocky Mountain Cancer Centers Thornton Colorado
Moffitt Cancer Center Tampa Florida
Minnesota Oncology Hematology, PA Coon Rapids Minnesota
Drug Storage and Regulatory location: MMCORC Saint Louis Park Minnesota
Metro Minnesota Community Oncology Research Consortium (MMCORC) Saint Louis Park Minnesota
Washington University School of Medicine - Obstetrics & Gynecology [Academic Offices) St Louis Missouri
Barnes-Jewish Hospital Investigational Drug Pharmacy (IDS) St Louis Missouri
Washington University School of Medicine - Obstetrics & Gynecology St Louis Missouri
Washington University School of Medicine [Patient Clinics] St Louis Missouri
Oncology Hematology West P.C. dba Nebraska Cancer Specialists Omaha Nebraska
Oncology Hematology West P.C. dba Nebraska Cancer Specialists Omaha Nebraska
NYU Langone Health - Long Island (Winthrop Hospital) Mineola New York
Perlmutter Cancer Center at NYU Langone GYN Oncology Associates Mineola New York
Perlmutter Cancer Center at NYU Langone Hospital - Long Island Mineola New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone New York New York
NYU Langone Medical Center New York New York
Icahn School of Medicine at Mount Sinai New York New York
Duke University Medical Center/Duke Cancer Center Durham North Carolina
University Hospitals Cleveland Medical Center Cleveland Ohio
OSU Wexner Medical Center, CarePoint East Columbus Ohio
OSU Wexner Medical Center, Ohio State University Hospital East Columbus Ohio
OSU Wexner Medical Center, Arther G. James Cancer Hospital, and Solove Research Institute Columbus Ohio
OSU Wexner Medical Center, Investigational Drug Services(IP Ship to) Columbus Ohio
Osu Wexner Medical Center, The Ohio State University Hospital Columbus Ohio
OSU Wexner Medical Center, Stephanie Spielman Comprehensive Breast Center Columbus Ohio

+ 68 more sites — see the full list on the official registry below.

On this site

📄 Herceptin (trastuzumab) drug profile →

More Seagen, a wholly owned subsidiary of Pfizer trials in Spain

A Study of Disitamab Vedotin in Previously Treated Solid Tumors That Express HER2 Active, not recruiting
A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer Recruiting
A Study of SGN-CEACAM5C in Adults With Advanced Solid Tumors Recruiting
A Study of Disitamab Vedotin With Other Anticancer Drugs in Solid Tumors Active, not recruiting
A Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses HER2 Recruiting

Other trials for the same condition

Phase 1 Study of CK-301 (Cosibelimab) as a Single Agent in Subjects With Advanced Cancers Active, not recruiting
A Study of JNJ-86974680 in Participants With Advanced Non-small Cell Lung Cancer Active, not recruiting
Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib Active, not recruiting
Study of Pembrolizumab With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib in Stage III Non-Small Cell Lung Cancer (NSCLC) (MK-7339-012/KEYLYNK-012) Active, not recruiting
A Study of Disitamab Vedotin in Previously Treated Solid Tumors That Express HER2 Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04579380 on ClinicalTrials.gov ↗ ← All trials in Spain