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New drug shows promise for Hard-to-Treat cancers in early trial

NCT ID NCT05382364

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

25 people

The number who actually took part.

Started

Jun 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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

  • Fudan University Shanghai Cancer Center

    Shanghai, 201321, China

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081, China

  • Hunan Cancer Hospital

    Changsha, Hunan, 421000, China

  • Jilin Cancer Hospital

    Changchun, Jilin, 130012, China

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, 300060, China

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