Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04579380|
Recruitment Status : Recruiting
First Posted : October 8, 2020
Last Update Posted : November 28, 2022
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 HER2 Mutations 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, gastric or gastroesophageal junction adenocarcinoma [GEC], and colorectal cancer [CRC]) or HER2-mutated solid tumor types.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||270 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Tucatinib + Trastuzumab (+ Fulvestrant)
Tucatinib + trastuzumab (+ fulvestrant in hormone-receptor positive HER2-mutant breast cancer only)
300 mg orally twice daily
Other Name: TUKYSA, ARRY-380, ONT-380
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
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
- 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
- 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 treatment initiation to death due to any cause.
- Incidence of adverse events (AEs) [ Time Frame: From start of treatment up to approximately 2 years ]Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
- Incidence of laboratory abnormalities [ Time Frame: From start of treatment up to approximately 2 years ]To be summarized using descriptive statistics.
- Incidence of dose alterations [ Time Frame: From start of treatment up to approximately 2 years ]
- Maximum concentration (Cmax) [ Time Frame: Approximately 4 months, during first 6 cycles of treatment ]To be summarized using descriptive statistics.
- Trough concentration (Ctrough) [ Time Frame: Approximately 4 months, during first 6 cycles of treatment ]To be summarized using descriptive statistics.
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
|Contact: Seagen Trial Information Supportfirstname.lastname@example.org|
|Study Director:||Jorge Ramos, DO||Seagen Inc.|