Clinical trial · Interventional
Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study
Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Phase II Platform Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
TAPISTRY is a Phase II, global, multicenter, open-label, multi-cohort study designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or in rational, specified combinations in participants with unresectable, locally advanced or metastatic solid tumors determined to harbor specific oncogenic genomic alterations or who are tumor mutational burden (TMB)-high as identified by a validated next-generation sequencing (NGS) assay. Participants with solid tumors will be treated with a drug or drug regimen tailored to their NGS assay results at screening. Participants will be assigned to the appropriate cohort based on their genetic alteration(s). Treatment will be assigned on the basis of relevant oncogenotype, will have cohort-specific inclusion/exclusion criteria, and, unless otherwise specified, will continue until disease progression, loss of clinical benefit, unacceptable toxicity, participant or physician decision to discontinue, or death, whichever occurs first.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (10)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alectinib | Drug | Alectinib | ALIAS |
| Atezolizumab | Drug | Atezolizumab | ALIAS |
| Belvarafenib | Drug | Belvarafenib | ALIAS |
| Camonsertib | Drug | Camonsertib | ALIAS |
| Divarasib | Drug | Divarasib | ALIAS |
| Entrectinib | Drug | Entrectinib | ALIAS |
| Inavolisib | Drug | Inavolisib | ALIAS |
| Ipatasertib | Drug | Ipatasertib | ALIAS |
| Pralsetinib |
Design
Arms and outcomes
Arms (13)
- type
- EXPERIMENTAL
- label
- Cohort A: ROS Proto-oncogene 1 (ROS1) Fusion-positive Tumors (Excluding NSCLC)
- description
- Participants with metastatic or advanced solid tumors, with the exception of non-small cell lung cancer (NSCLC), will receive entrectinib once daily (QD) in repeated 28-day cycles at a dose of 600 milligram per day (mg/day) for adults and pediatric participants with a body surface area (BSA) ≥ 1.51 square meter (m\^2). The total dose of daily entrectinib administration for pediatric participants with BSA \< 1.51 m\^2 will be lower.
- interventionNames
- Drug: Entrectinib
- type
- EXPERIMENTAL
- label
- Cohort B: Neurotrophic Tyrosine Receptor Kinase (NTRK) 1/2/3 Fusion-positive Tumors
- description
- Participants with metastatic or advanced solid tumors will receive entrectinib, QD in repeated 28-day cycles at a dose of 600 mg/day for adults and pediatric participants with a BSA ≥ 1.51 m\^2. The total dose of daily entrectinib administration for pediatric participants with BSA \< 1.51 m\^2 will be lower.
- interventionNames
- Drug: Entrectinib
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDBagchi A, Chiang J, Pinto S, Dhanda S, Gajjar A. Infant-Type Hemispheric Gliomas: A Review of Clinical, Radiologic, Histopathologic, and Molecular Features. J Natl Compr Canc Netw. 2025 Nov;23(11):e257064. doi: 10.6004/jnccn.2025.7064. PMID 41213248
- DERIVEDDesai AV, Bagchi A, Armstrong AE, van Tilburg CM, Basu EM, Robinson GW, Wang H, Casanova M, Andre N, Campbell-Hewson Q, Wu Y, Cardenas A, Ci B, Ryklansky C, Devlin CE, Meneses-Lorente G, Wulff J, Hutchinson KE, Gajjar A, Fox E. Efficacy and safety of entrectinib in children with extracranial solid or central nervous system (CNS) tumours harbouring NTRK or ROS1 fusions. Eur J Cancer. 2025 May 2;220:115308. doi: 10.1016/j.ejca.2025.115308. Epub 2025 Feb 22. PMID 40086048