Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations
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| ClinicalTrials.gov Identifier: NCT04579380 |
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Recruitment Status :
Recruiting
First Posted : October 8, 2020
Last Update Posted : March 2, 2021
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Sponsor:
Seagen Inc.
Information provided by (Responsible Party):
Seagen Inc.
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Uterine Neoplasms Uterine Cervical Neoplasms Biliary Tract Neoplasms Urologic Neoplasms Carcinoma, Non-Small-Cell Lung Breast Neoplasms | Drug: tucatinib Drug: trastuzumab Drug: fulvestrant | Phase 2 |
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, GEC, and CRC) or HER2-mutated solid tumor types.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 270 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Actual Study Start Date : | January 11, 2021 |
| Estimated Primary Completion Date : | January 31, 2023 |
| Estimated Study Completion Date : | May 31, 2025 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Tucatinib + Trastuzumab (+ Fulvestrant)
Tucatinib + trastuzumab (+ fulvestrant in hormone-receptor positive HER2-mutant breast cancer only)
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Drug: tucatinib
300 mg orally twice daily
Other Name: TUKYSA, ARRY-380, ONT-380 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
Other Name: Herceptin 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.
Other Name: Faslodex |
Primary Outcome Measures :
- Confirmed objective response rate (cORR) per investigator assessment [ Time Frame: From start of treatment up to approximately 2 years ]cORR is defined as the proportion of participants with best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Secondary Outcome Measures :
- Disease control rate (DCR) per investigator assessment [ Time Frame: From start of treatment up to approximately 2 years ]DCR is defined as the proportion of participants with confirmed CR, confirmed PR, or stable disease according to RECIST v1.1
- Duration of response (DOR) per investigator assessment [ Time Frame: From start of treatment up to approximately 2 years ]DOR is defined as the time from first documentation of objective response of confirmed CR or confirmed PR to the first documentation of disease progression per RECIST v1.1 or death from any cause, whichever occurs first.
- Progression-free survival (PFS) per investigator assessment [ Time Frame: From start of treatment up to approximately 2 years ]PFS is defined as the time from the date of treatment initiation to the date of disease progression according to RECIST v1.1 or death from any cause, whichever occurs first.
- Overall survival (OS) [ Time Frame: From start of treatment up to approximately 4 years ]OS is defined as the time from treatlemt initiation to death due to any cause.
- Incidence of adverse events (AEs) [ Time Frame: From start of treatment up to approximately 2 years ]
- Incidence of laboratory abnormalities [ Time Frame: From start of treatment up to approximately 2 years ]
- Incidence of dose alterations [ Time Frame: From start of treatment up to approximately 2 years ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria
- Histologically or cytologically confirmed diagnosis of locally-advanced unresectable or metastatic solid tumor, including primary brain tumors
- Participants with disease types other than breast cancer, biliary tract cancer, non-squamous NSCLC, and cervical cancer: Disease progression on or after the most recent systemic therapy for locally-advanced unresectable or metastatic disease
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Participants with any breast cancer subtype:
- Must have HER2-mutated disease which does not display HER2 overexpression/amplification
- Must have progressed on or after ≥1 prior line of treatment (chemotherapy, endocrine therapy, or targeted therapy) for locally-advanced unresectable or metastatic breast cancer
- Participants with metastatic HR+ HER2-mutated disease must have received a prior CDK4/6 inhibitor in the metastatic setting.
- Participants with biliary tract cancer: must have completed ≥1 prior line of treatment (chemotherapy, endocrine therapy, or targeted therapy)
- Participants with non-squamous NSCLC: has relapsed from or is refractory to standard treatment or for which no standard treatment is available
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Participants with cervical cancer:
- Participants with metastatic cervical cancer must have progressed on or after ≥1 prior line of systemic therapy in the metastatic setting.
- Participants with locally advanced unresectable cervical cancer must have progressed on or after ≥1 prior lines 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, GEC, or CRC whose disease shows HER2 amplification/overexpression.
- Previous treatment with HER2-directed therapy; participants with uterine serous carcinoma 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, 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04579380
Contacts
| Contact: Seagen Trial Information Support | 8663337436 | clinicaltrials@seagen.com |
Locations
| United States, Arizona | |
| Arizona Oncology Associates, PC - HAL | Recruiting |
| Phoenix, Arizona, United States, 85016 | |
| United States, California | |
| Pacific Shores Medical Group | Recruiting |
| Long Beach, California, United States, 90813 | |
| United States, Minnesota | |
| HealthPartners Institute | Recruiting |
| Saint Louis Park, Minnesota, United States, 55416 | |
| Principal Investigator: Daniel Anderson | |
| United States, North Carolina | |
| Duke University Medical Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Principal Investigator: Thomas Stinchcombe | |
| United States, Tennessee | |
| Tennessee Oncology-Nashville/Sarah Cannon Research Institute | Recruiting |
| Nashville, Tennessee, United States, 37203 | |
| Principal Investigator: Erika Hamilton | |
| United States, Virginia | |
| Virginia Cancer Specialists, PC | Recruiting |
| Fairfax, Virginia, United States, 22031 | |
| Principal Investigator: Alexander Spira | |
| United States, Washington | |
| Northwest Cancer Specialists, P.C. | Recruiting |
| Vancouver, Washington, United States, 98684 | |
Sponsors and Collaborators
Seagen Inc.
Investigators
| Study Director: | Vicky Kang, MD | Seagen Inc. |
| Responsible Party: | Seagen Inc. |
| ClinicalTrials.gov Identifier: | NCT04579380 |
| Other Study ID Numbers: |
SGNTUC-019 |
| First Posted: | October 8, 2020 Key Record Dates |
| Last Update Posted: | March 2, 2021 |
| Last Verified: | February 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Seagen Inc.:
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Cervical cancer Uterine cancer Biliary tract cancer Gallbladder cancer Cholangiocarcinoma Urothelial cancer Non-squamous non-small cell lung cancer |
Non-squamous NSCLC Breast cancer Colorectal cancer Ampullary cancer Solid tumors Solid tumors harboring somatic HER2 mutations Seattle Genetics |
Additional relevant MeSH terms:
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Neoplasms Breast Neoplasms Carcinoma, Non-Small-Cell Lung Uterine Cervical Neoplasms Uterine Neoplasms Biliary Tract Neoplasms Urologic Neoplasms Neoplasms by Site Breast Diseases Skin Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms |
Lung Diseases Respiratory Tract Diseases Genital Neoplasms, Female Urogenital Neoplasms Uterine Cervical Diseases Uterine Diseases Digestive System Neoplasms Biliary Tract Diseases Digestive System Diseases Trastuzumab Fulvestrant Antineoplastic Agents, Immunological Antineoplastic Agents Antineoplastic Agents, Hormonal Estrogen Receptor Antagonists |