New drug shows promise for Hard-to-Treat cancers in early trial
NCT ID NCT05382364
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests the safety of tucatinib in about 25 Chinese patients with advanced HER2+ breast, stomach, or colorectal cancer that has worsened after standard treatments. Researchers will monitor side effects and how the drug moves through the body. The goal is to see if tucatinib is safe enough for further study.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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25 people
The number who actually took part.
- Started
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Jun 2022
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Fudan University Shanghai Cancer Center
Shanghai, 201321, China
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Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081, China
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Hunan Cancer Hospital
Changsha, Hunan, 421000, China
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Jilin Cancer Hospital
Changchun, Jilin, 130012, China
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Tianjin Medical University Cancer Institute and Hospital
Tianjin, 300060, China
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