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Personalized treatment for advanced solid tumors based on genetic testing

Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Phase II Platform Trial

Phase 2 Interventional Hoffmann-La Roche · NCT04589845

This study is testing if personalized treatments based on genetic testing can help people with advanced solid tumors feel better and live longer.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment920 (estimated)
SexAll
SponsorHoffmann-La Roche Industry-sponsored
Drugs / interventionsimmunotherapy
Locations174 sites (Daphne, Alabama and 173 other locations)
Trial IDNCT04589845 on ClinicalTrials.gov

What this trial studies

The TAPISTRY platform study is a Phase II, global, multicenter, open-label trial that aims to evaluate the safety and efficacy of targeted therapies and immunotherapy for patients with unresectable, locally advanced, or metastatic solid tumors. Participants will be assigned to treatment cohorts based on specific oncogenic genomic alterations identified through next-generation sequencing (NGS). The study will assess the effectiveness of these tailored therapies until disease progression or other specified discontinuation criteria are met. This approach seeks to optimize treatment by matching patients with therapies that target their unique tumor characteristics.

Who should consider this trial

Good fit: Ideal candidates include adults and adolescents with advanced, unresectable, or metastatic solid tumors that have specific genomic alterations or high tumor mutational burden.

Not a fit: Patients with solid tumors that do not harbor the targeted genomic alterations or who are not TMB-high may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide more effective, personalized treatment options for patients with advanced solid tumors.

How similar studies have performed: Other studies utilizing targeted therapies based on genomic profiling have shown promising results, indicating that this approach is gaining traction in oncology.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of advanced and unresectable or metastatic solid malignancy
* Measurable disease as defined by RECIST v1.1, RANO, or INRC
* Performance status as follows: Participants aged ≥ 18 years: Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2; Participants aged 16 to \< 18 years: Karnofsky score ≥ 50%; Participants aged \< 16 years: Lansky score ≥ 50%
* For participants aged ≥ 18 and \< 18 years: adequate hematologic and end-organ function
* Disease progression on prior treatment, or previously untreated disease with no available acceptable treatment
* Adequate recovery from most recent systemic or local treatment for cancer
* Life expectancy ≥ 8 weeks
* Ability to comply with the study protocol, in the investigator's judgment
* For female participants of childbearing potential: Negative serum pregnancy test ≤ 14 days prior to initiating study treatment, agreement to remain abstinent or use single or combined contraception methods that result in a failure rate of \< 1% per year for the period defined in the cohort-specific inclusion criteria; and agreement to refrain from donating eggs during the same period
* For male participants: Willingness to remain abstinent or use acceptable methods of contraception as defined in the cohort-specific inclusion criteria
* In addition to the general inclusion criteria above, participants must meet all of the cohort-specific inclusion criteria for the respective cohort

Exclusion Criteria:

* Current participation or enrollment in another therapeutic clinical trial
* Any anticancer treatment within 2 weeks or 5 half-lives prior to start of study treatment
* Whole brain radiotherapy within 14 days prior to start of study treatment
* Stereotactic radiosurgery within 7 days prior to start of study treatment
* Pregnant or breastfeeding, or intending to become pregnant during the study
* History of or concurrent serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study or confounds the ability to interpret data from the study
* Incomplete recovery from any surgery prior to the start of study treatment that would interfere with the determination of safety or efficacy of study treatment
* Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or higher), myocardial infarction, or cerebrovascular accident within 3 months prior to enrollment, unstable arrhythmias, or unstable angina
* History of another active cancer within 5 years prior to screening that may interfere with the determination of safety or efficacy of study treatment with respect to the qualifying solid tumor malignancy
* In addition to the general exclusion criteria above, in order to be enrolled in a treatment cohort of the study, participants must not meet any of the cohort-specific exclusion criteria

Where this trial is running

Daphne, Alabama and 173 other locations

+124 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Solid Tumors
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.