NCT05382364Active, not recruitingPhase 1
Safety and Pharmacokinetics of Tucatinib (MK-7119) in Chinese Participants With Cancer (MK-7119-002)
A Phase 1 Clinical Study to Investigate the Safety and Pharmacokinetics of Tucatinib (MK-7119) in China Participants With HER2+ Advanced Breast Cancer, Gastric or Gastroesophageal Junction Adenocarcinoma and Colorectal Cancer
Source: ClinicalTrials.gov · Last updated 12 Mar 2026
Brief summary (registry, in English)
The primary purpose of this study is to characterize the safety and tolerability of tucatinib (MK-7119) in Chinese participants with human epidermal growth factor receptor 2 positive (HER2+) advanced breast cancer, gastric or gastroesophageal junction adenocarcinoma (GEC), and colorectal cancer.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 25 (actual)
- First submitted
- 16 May 2022
- Start date
- 29 Jun 2022
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Pfizer
- NCT number
- NCT05382364
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 25
- From 29 Jun 2022 to the primary completion date, 31 Dec 2026
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has had chemotherapy, immunotherapy, radioimmunotherapy, definitive radiation, or biological cancer therapy or treatment with an investigational product within 4 weeks (2 weeks for palliative radiation) before the first dose of study intervention
- Has had major surgery within 4 weeks prior to first dose of study intervention
Other illness
- History of prior cancer within \<3 year, except for adequately treated basal cell or squamous cell carcinoma of the skin, cervical cancer in situ, or other in situ carcinomas which needs discussion between the investigator and the Sponsor
- Participants with leptomeningeal disease are excluded
- Has active human immunodeficiency virus (HIV), hepatitis B virus, or HCV infection
- Has an active infection requiring therapy
- Has refractory nausea/vomiting, chronic gastrointestinal disease, or significant bowel resection
- Has uncontrolled illness including but not limited to ongoing symptomatic congestive heart failure (New York Heart Association \[NYHA\] Class III or IV heart failure), unstable angina pectoris, cardiac arrhythmia, and psychiatric illness that would limit compliance with study requirements
- Has psychiatric or substance abuse disorder
Lab values
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study
- Has a QTc prolongation
Other
- Has symptomatic central nervous system (CNS) metastases
- Is currently participating in another clinical trial
Who the study is looking for
- Histologically or cytologically confirmed HER2+ advanced breast cancer, gastric or GEC, and colorectal cancer
- Have progressed at least one previous therapeutic regimen and either no longer are candidates for standard therapy, have no standard therapy available, or choose not to pursue standard therapy
- Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance within 7 days prior to allocation
- Has life expectancy \>6 months in the opinion of the investigator
- Have measurable disease per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 as assessed by the local site investigator/radiologist
- Must test negative for hepatitis B surface antigen (HBsAg)
- If there is a history of hepatitis C virus (HCV) infection, has undetectable HCV viral load at screening
- For males, agree to be abstinent from heterosexual intercourse, or agree to use acceptable contraception, for the duration of study and 1 week after
- For females, is not pregnant or breastfeeding AND one of the following applies:
- Is not a woman of childbearing potential (WOCBP)
- Is a WOCBP and uses highly effective contraception and is not pregnant
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jilin Cancer Hospital Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| Hunan Cancer Hospital Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Harbin Medical University Cancer Hospital Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Tianjin Medical University Cancer Institute and Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.