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Gene-Guided cancer therapy: a new hope for advanced tumors?

NCT ID NCT05525858

Knowledge-focused Sponsor: Seoul National University Bundang Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study enrolls 1,000 adults with advanced solid tumors that have progressed after standard treatment. Researchers will use genetic tests to match patients to specific drugs, like Alectinib or Atezolizumab, based on their tumor's gene changes. The goal is to see if this personalized approach is feasible and helps control the cancer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Alectinib, Atezolizumab, and other targeted/immunotherapies based on genomic alterations
What this could lead to
If successful, this could show that using genetic tests to choose cancer treatments improves outcomes for people with advanced solid tumors who have run out of standard options.
What could go wrong
This is an early-stage feasibility study, not a large confirmatory trial. The treatments are used outside their approved indications, so benefits are uncertain and there may be unexpected side effects.

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.

Participants

About 1,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2022

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Histologically proven locally advanced or metastatic solid tumor patients with disease progression on standard first line anti-cancer treatment and/or has no standard treatment option

Ages

19 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: * 19 years of age or older * Histologically proven locally advanced or metastatic solid tumors\*\*\* who showed disease progression on standard first line anti-cancer treatment and/or has no standard treatment option \*\*\* very rare diseases without standard treatment option which form solid mass, such as Erdheim Chester disease can be enrolled after KOSMOS MTB approval * A genomic test results must be available in a MFDS-accredited for laboratories offering service, or in part of clinical trial/study or other commercial labs approved and certified by regulatory bodies compatible with MFDS, such as CLIA. A genomic test can be conducted with tumor tissue as well as plasma circulating tumor DNA. 1. Results from genomic profiling tests performed after diagnosis with metastatic/advanced disease to registration are acceptable. NGS results performed within three years prior to registration are preferred. Those patients with NGS results from primary tumor or more than 3 years prior to enrollment can be registered and whether NGS data is acceptable will be subject to MTB decision. 2. NGS panels should be i. Tested in a lab that is accredited by one or more quality assurance program (e.g., Korean Institute of Genomic Testing Evaluation, The Korean Society of Pathologists, Korean Society for Laboratory Medicine, Korea Laboratory Accreditation Scheme, etc.) ii. Patients who have insufficient genomic information from their NGS results (e.g., lack of variant calling format file or uninterpretable reports) or who are candidates of immunotherapy will submit their tissue and/or blood, for central NGS testing and exploratory biomarker analysis. * Ability to understand and the willingness to sign a written informed consent document * Life expectancy of at least 12 weeks * Adequate recovery from most recent systemic or local treatment for cancer. Exclusion Criteria: * Patients receiving any anti-cancer treatment (local treatment, chemotherapy, immunotherapy, targeted therapy) within 2 weeks prior to the start of study treatment * Any clinical condition, according to the opinion of site physicians, which makes molecular profiling guided therapy not at the best interest of the participating patient. * Patients who have ongoing toxicities of ≥ CTCAE 2, other than peripheral neuropathy, related to previous anti-cancer treatment. Patients with ongoing peripheral neuropathy of ≥ CTCAE 3 will be excluded. Laboratory abnormalities ≥ CTCAE 2 considered as not clinically significant by the study physician will be allowed. * Pregnant or breastfeeding, or intending to become pregnant during the study

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Conditions

The condition(s) this trial relates to.

metastatic malignant neoplasm neoplasm Neoplasm Metastasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumor Metastatic cancer Solid tumor

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    30 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ajou University Hospital

    RECRUITING

    Suwon, South Korea

  • Asan Medical Center

    RECRUITING

    Seoul, South Korea

  • Cha University Bundang Medical Center

    RECRUITING

    Seongnam, South Korea

  • Chonnam National University Hwasun Hospital

    RECRUITING

    Hwasun, South Korea

  • Chung-ang University Hospital

    RECRUITING

    Seoul, South Korea

  • Chungbuk National University Hospital

    RECRUITING

    Chungju, South Korea

  • Chungnam National University Hospital

    RECRUITING

    Daejeon, South Korea

  • Dong-A University Hospital

    RECRUITING

    Pusan, South Korea

  • Ewha womans university Mokdong Hospital

    RECRUITING

    Seoul, South Korea

  • Gachon University Gil Medical Center

    RECRUITING

    Incheon, South Korea

  • Gangbuk Samsung Hospital

    RECRUITING

    Seoul, South Korea

  • Gyeongsang National University Hospital

    RECRUITING

    Jinju, South Korea

  • Hanyang University Hospital

    TERMINATED

    Seoul, South Korea

  • Jeonbuk National University Hospital

    RECRUITING

    Jeonju, South Korea

  • Keimyung University Dongsan Hospital

    RECRUITING

    Daegu, South Korea

  • Korea University Anam Hospital

    RECRUITING

    Seoul, South Korea

  • Korea University Guro Hospital

    RECRUITING

    Seoul, South Korea

  • Kyungpook National University Chilgok Hospital

    RECRUITING

    Daegu, South Korea

  • National Cancer Center

    RECRUITING

    Goyang, South Korea

  • Pusan National University Yangsan Hospital

    RECRUITING

    Yangsan, South Korea

  • Samsung Medical Center

    RECRUITING

    Seoul, South Korea

  • Seoul National University Bundang Hospital

    RECRUITING

    Seongnam, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, South Korea

  • Soonchunhyang University Hospital Bucheon

    RECRUITING

    Bucheon-si, South Korea

  • The Catholic University of Korea, Incheon St. Mary's Hospital

    RECRUITING

    Incheon, South Korea

  • The Catholic University of Korea, ST. Vincent's Hospital

    RECRUITING

    Suwon, South Korea

  • The Catholic University of Korea, Seoul ST. Mary's Hospital

    RECRUITING

    Seoul, South Korea

  • The Catholic University of Korea, Yeouido St. Mary's Hospital

    RECRUITING

    Seoul, South Korea

  • Ulsan University Hospital

    RECRUITING

    Ulsan, South Korea

  • Wonju Severance Christian Hospital

    TERMINATED

    Wŏnju, South Korea

  • Yeungnam University Medical Center

    RECRUITING

    Daegu, South Korea

  • Yonsei Cancer Hospital

    RECRUITING

    Seoul, South Korea

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