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Gene-Tailored therapy could be Game-Changer for rare cancer patients

NCT ID NCT06855134

Knowledge-focused Sponsor: German Cancer Research Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 08, 2026 · Updated 2 times

Summary

This study tests whether using a patient's unique genetic information to choose their cancer treatment leads to better results than standard care. About 946 adults with advanced rare cancers will be randomly assigned to either immediate personalized treatment or standard treatment first. The goal is to see if the personalized approach slows cancer growth and improves survival.

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 946 people

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

Started

Sep 2025

Expected to finish

Apr 2030

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

Patients with locally advanced and/or metastatic rare epithelial or mesenchymal cancer (equal numbers of patients) without curative treatment option

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: * Age ≥ 18years, no upper age limit * Patients with locally advanced and/or metastatic rare epithelial or mesenchymal cancer (equal numbers of patients) without curative treatment option * Progressive disease or expected progression of the disease estimated by clinical parameters, suitable biomarkers, and other (e.g. radiographic) methods \* At least one measurable lesion that has been accurately assessed by computed tomography (CT) or magnetic resonance imaging (MRI) at baseline and is amenable to repeat evaluation in MRI/CT images * Patients must have received at least one standard therapy for advanced disease according to current guidelines or consensus recommendations or have no standard therapy available * Possibility to perform fresh tumor biopsy according to local SOPs or Availability of fresh frozen tumor samples with sufficient tumor cell content collected within 3 months prior to enrolment * ECOG PS ≤ 2. * Ability of patient to understand character and consequences of the clinical trial * Patient must be willing and able to undergo subsequent treatment (e.g. in a clinical trial) with molecularly guided therapy according to the MTB recommendation * Availability of complete information about all medical treatment given before study participation, i.e. remission status before start of treatment, dosage and timing of drugs applied, remission status and date of progression after treatment Exclusion Criteria: * Dementia or significant cognitive impairment * Epilepsy requiring pharmacologic treatment * Prior allogeneic bone marrow or solid organ transplantation * Hematological malignancies and primary brain tumors. * Prior comprehensive molecular profiling by WGS, WES, RNA-Seq, or large targeted panels. * Patients with symptomatic or uncontrolled brain metastases and patients with symptomatic or uncontrolled spinal cord compression. Patients with previously treated brain metastases are eligible, provided that the patient has neither experienced a seizure nor had a clinically significant change in neurological status within the three months prior to enrollment. All patients with previously treated brain metastases must be clinically stable for at least 1 month after completion of treatment and off steroid treatment for one month, both prior to study enrollment. * Malignancy other than study indication within the last 5 years except: curatively treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), Stage 1, grade 1 endometrial carcinoma, low-risk prostate cancer, or other malignancies curatively treated with no evidence of disease for ≥5 years. * History of intracranial hemorrhage or spinal cord haemorrhage; no ongoing requirement for dexamethasone for CNS disease; patients on a stable dose of anticonvulsants are permitted * Known uncontrolled or significant cardiovascular disease, including any of the following: * History of heart failure NYHA class 3 or 4 * History of uncontrolled angina pectoris, arrhythmias, or myocardial infarction within 12 months prior to screening. * History of liver cirrhosis * Neurologic or psychiatric disorder interfering with ability of giving informed consent. * Known or suspected active alcohol or drug abuse. * Patients with inability to receive oral medications. * Failure to provide consent for the registration, storage, and processing of individual disease characteristics and clinical course, as well as for informing the primary care physician about the participant's involvement in the study.

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Conditions

The condition(s) this trial relates to.

sarcoma

As listed by the trial registrant

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

Rare cancer

How to take part

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

  1. The places running it

    16 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

  • Charité Berlin

    RECRUITING

    Berlin, 10117 Berlin, Germany

  • Comprehensive Cancer Center , LMU München

    NOT_YET_RECRUITING

    München, 81377, Germany

  • Comprehensive Cancer Center Ostbayern (CCCO) Universitätsklinikum Regensburg,

    RECRUITING

    Regensburg, 93053, Germany

  • Medizinische Fakultät der TU Dresden

    RECRUITING

    Dresden, 01307, Germany

  • Robert Bosch Krankenhaus Stuttgart

    RECRUITING

    Stuttgart, 70376, Germany

  • Uniklinikum Erlangen

    RECRUITING

    Erlangen, 91054, Germany

  • Universitäts-Klinikum Köln

    RECRUITING

    Cologne, 50937, Germany

  • Universitätsklinikum Augsburg

    RECRUITING

    Augsburg, 86156, Germany

  • Universitätsklinikum Freiburg, Tumorzentrum Freiburg - CCCF

    NOT_YET_RECRUITING

    Freiburg im Breisgau, 79106, Germany

  • Universitätsklinikum Hamburg-Eppendorf (UKE)

    NOT_YET_RECRUITING

    Hamburg, 20246, Germany

  • Universitätsklinikum Heidelberg

    RECRUITING

    Heidelberg, 69120, Germany

  • Universitätsklinikum Tübingen

    RECRUITING

    Tübingen, 72076, Germany

  • Universitätsklinikum Ulm

    RECRUITING

    Ulm, 89081, Germany

  • Universitätsklinium Würzburg

    RECRUITING

    Würzburg, 97080, Germany

  • Universitätsmedizin Essen

    RECRUITING

    Essen, 45147, Germany

  • Universitätsmedizin der Johannes Gutenberg- Universität Mainz

    NOT_YET_RECRUITING

    Mainz, 55131, Germany

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