Metastatic HER2+ Advanced Breast CancerPhase 1NCT05382364
Safety and Pharmacokinetics of Tucatinib (MK-7119) in Chinese Participants With Cancer (MK-7119-002)
A Phase 1 study testing Tucatinib in people with Metastatic HER2+ Advanced Breast Cancer and Breast Neoplasms, run by Pfizer at 5 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic HER2+ Advanced Breast Cancer, Breast Neoplasms, Gastric or Gastroesophageal Junction Adenocarcinoma (GEC)
- What is being tested?
- Tucatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 5 sitesChina
- Study dates
- 29 Jun 2022to 31 Dec 2026
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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 symptomatic central nervous system (CNS) metastases
- Has active human immunodeficiency virus (HIV), hepatitis B virus, or HCV infection
- 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 an active infection requiring therapy
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- Has refractory nausea/vomiting, chronic gastrointestinal disease, or significant bowel resection
- 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
- 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 had major surgery within 4 weeks prior to first dose of study intervention
- Is currently participating in another clinical trial
- Has psychiatric or substance abuse disorder
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Jilin Cancer Hospital
Changchun, Jilin, 130012
Hunan Cancer Hospital
Changsha, Hunan, 421000
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Fudan University Shanghai Cancer Center
Shanghai, 201321
Tianjin Medical University Cancer Institute and Hospital
Tianjin, 300060
About this study
Official title: 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
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.
- Conditions
- Metastatic HER2+ Advanced Breast Cancer, Breast Neoplasms, Gastric or Gastroesophageal Junction Adenocarcinoma (GEC), Colorectal Cancer
- Being tested
- Tucatinib
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TucatinibDrug
Also called MK-7119
Tucatinib 150 mg and 50 mg tablets taken by mouth at a dose of 300 mg twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Tucatinib Treatment | Experimental | Chinese participants with HER2+ advanced breast cancer, gastric or gastroesophageal junction adenocarcinoma, or colorectal cancer receive tucatinib 300 mg by mouth twice daily during 21-day cycles. Treatment continues until there is evidence of unacceptable toxicity or documented progression. Receives: Drug: Tucatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with ≥1 adverse event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Measured: Up to approximately 2.5 years
Percentage of participants discontinuing from study therapy due to AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Measured: Up to approximately 2.5 years
Secondary outcomes (16)
Maximum plasma concentration (Cmax) of first dose of tucatinib
The Cmax of tucatinib will be determined after the first dose.
Measured: Cycle 1, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose
Time of maximum plasma concentration (Tmax) of first dose of tucatinib
The Tmax of tucatinib will be determined after the first dose.
Measured: Cycle 1, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose
Area under the plasma concentration time curve from dosing to 12 hours postdose (AUC0-12) of first dose of tucatinib
The AUC0-12 of tucatinib will be determined after the first dose.
Measured: Cycle 1, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose
Apparent plasma half-life (t½) of first dose of tucatinib
The t½ of tucatinib will be determined after the first dose.
Measured: Cycle 1, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose
Apparent clearance (CL/F) of first dose of tucatinib
The CL/F of tucatinib will be determined after the first dose.
Measured: Cycle 1, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose
Volume of distribution (Vz/F) of first dose of tucatinib
The Vz/F of tucatinib will be determined after the first dose.
Measured: Cycle 1, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose
Trough concentration (Ctrough) of tucatinib at steady state
The Ctrough of tucatinib will be determined at steady state.
Measured: Cycle 1, Days 8 and 15: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose
Accumulation ratio of tucatinib at steady state
The accumulation ratio of tucatinib will be determined at steady state.
Measured: Cycle 2, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose
Cmax at steady state (Cmaxss) of tucatinib
The Cmaxss of tucatinib will be determined at steady state.
Measured: Cycle 2, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose
Tmax at steady state (Tmaxss) of tucatinib
The Tmaxss of tucatinib will be determined at steady state.
Measured: Cycle 2, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose
AUC0-12 at steady state (AUC0-12ss) of tucatinib
The AUC0-12ss of tucatinib will be determined at steady state.
Measured: Cycle 2, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose
t½ of tucatinib at steady state
The t½ of tucatinib will be determined at steady state.
Measured: Cycle 2, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose
CL/F at steady state (CL/Fss) of tucatinib
The CL/Fss of tucatinib will be determined at steady state.
Measured: Cycle 2, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose
Vz/F at steady state (Vz/Fss) of tucatinib
The Vz/Fss of tucatinib will be determined at steady state.
Measured: Cycle 2, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose
Objective Response Rate (ORR) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)
ORR is defined as the percentage of participants who have a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience a CR or PR based on RECIST 1.1 will be presented.
Measured: Up to approximately 19 months
Duration of Response (DOR) Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)
For participants who demonstrate a confirmed complete response (CR: Disappearance of all target lesions) or confirmed Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until disease progression or death.
Measured: Up to approximately 19 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start29 Jun 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic HER2+ Advanced Breast CancerStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05382364
- Sponsor's protocol ID
- MK-7119-002
- Other IDs
- C4251016, 7119-002
- Status last verified
- Mar 2026
- First submitted
- 16 May 2022
- Last updated
- 12 Mar 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No