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: Solid Tumors
Eligibility 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
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
Eligibility criteria are kept as the original English records from ClinicalTrials.gov; actual eligibility is determined by the research team's formal assessment and the informed consent form. Source: ClinicalTrials.gov, updated automatically every two weeks. Last synced: 2026年10月8日.