Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study
About the study
Who can take part
INCLUSION CRITERIA
Inclusion Criteria:
- Histologically or cytologically confirmed diagnosis of advanced and unresectable or metastatic solid malignancy
- Measurable disease as defined by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1), Response Assessment in Neuro-Oncology (RANO) criteria, or International Neuroblastoma Response Criteria (INRC)
- Performance status as follows: Participantss aged >= 18 years: Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2; Participantss 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
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
Study Locations
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How to Apply
Study’s details
Contition
Solid Tumors
Phase
Phase 2
Participants needed
920
Est. Completion Date
Sep 25, 2032
Treatment type
Interventional
Sponsor
Hoffmann-La Roche
ClinicalTrials.gov identifier
NCT04589845
Study number
BO41932
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