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Active, not recruitingNCT05382364Updated Mar 12, 2026

Safety and Pharmacokinetics of Tucatinib (MK-7119) in Chinese Participants With Cancer (MK-7119-002)

A Phase 1 interventional study of Tucatinib in Metastatic HER2+ Advanced Breast Cancer, Breast Neoplasms and Gastric or Gastroesophageal Junction Adenocarcinoma (GEC), sponsored by Pfizer. Active, not recruiting at 5 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-12.

Sponsored by Pfizer · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Metastatic HER2+ Advanced Breast Cancer
  • Breast Neoplasms
  • Gastric or Gastroesophageal Junction Adenocarcinoma (GEC)
  • Colorectal Cancer
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 25 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    Tucatinib Treatment

    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.

    Drug: Tucatinib

Interventions

  • DrugTucatinib

    Tucatinib 150 mg and 50 mg tablets taken by mouth at a dose of 300 mg twice daily.

    Also known as: MK-7119

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to approximately 2.5 years

  2. 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.

    Time frame: Up to approximately 2.5 years

Secondary outcomes

  1. Maximum plasma concentration (Cmax) of first dose of tucatinib

    The Cmax of tucatinib will be determined after the first dose.

    Time frame: Cycle 1, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose

  2. Time of maximum plasma concentration (Tmax) of first dose of tucatinib

    The Tmax of tucatinib will be determined after the first dose.

    Time frame: Cycle 1, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose

  3. 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.

    Time frame: Cycle 1, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose

  4. Apparent plasma half-life (t½) of first dose of tucatinib

    The t½ of tucatinib will be determined after the first dose.

    Time frame: Cycle 1, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose

  5. Apparent clearance (CL/F) of first dose of tucatinib

    The CL/F of tucatinib will be determined after the first dose.

    Time frame: Cycle 1, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose

  6. Volume of distribution (Vz/F) of first dose of tucatinib

    The Vz/F of tucatinib will be determined after the first dose.

    Time frame: Cycle 1, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose

  7. Trough concentration (Ctrough) of tucatinib at steady state

    The Ctrough of tucatinib will be determined at steady state.

    Time frame: Cycle 1, Days 8 and 15: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose

  8. Accumulation ratio of tucatinib at steady state

    The accumulation ratio of tucatinib will be determined at steady state.

    Time frame: Cycle 2, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose

  9. Cmax at steady state (Cmaxss) of tucatinib

    The Cmaxss of tucatinib will be determined at steady state.

    Time frame: Cycle 2, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose

  10. Tmax at steady state (Tmaxss) of tucatinib

    The Tmaxss of tucatinib will be determined at steady state.

    Time frame: Cycle 2, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose

  11. AUC0-12 at steady state (AUC0-12ss) of tucatinib

    The AUC0-12ss of tucatinib will be determined at steady state.

    Time frame: Cycle 2, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose

  12. t½ of tucatinib at steady state

    The t½ of tucatinib will be determined at steady state.

    Time frame: Cycle 2, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose

  13. CL/F at steady state (CL/Fss) of tucatinib

    The CL/Fss of tucatinib will be determined at steady state.

    Time frame: Cycle 2, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose

  14. Vz/F at steady state (Vz/Fss) of tucatinib

    The Vz/Fss of tucatinib will be determined at steady state.

    Time frame: Cycle 2, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose

  15. 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.

    Time frame: Up to approximately 19 months

  16. 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.

    Time frame: Up to approximately 19 months

07

Study locations

5 sites
  • Harbin Medical University Cancer Hospital
    Harbin, Heilongjiang 150081, China
  • Hunan Cancer Hospital
    Changsha, Hunan 421000, China
  • Jilin Cancer Hospital
    Changchun, Jilin 130012, China
  • Fudan University Shanghai Cancer Center
    Shanghai, 201321, China
  • Tianjin Medical University Cancer Institute and Hospital
    Tianjin, 300060, China
08

References and documents

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05382364
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
May 19, 2022
Start date
Jun 29, 2022
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Mar 12, 2026

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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