Brief Summary
TAPISTRY is a Phase II, global, multicenter, open-label, multi-cohort study designed to evaluate the safety and efficacy of targeted therapies or immunotherapya treatment that uses a person's immune system to fight cancer as single agents or in rational, specified combinations in participants with unresectable, locally advancedat a late stage, far along 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 screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer 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.
Intervention / Treatment
- Drug: Entrectinib
- Drug: Entrectinib
- Drug: Alectinib
- Drug: Atezolizumab
- Drug: Ipatasertib
- Drug: Trastuzumab emtansine
- Drug: Idasanutlin
- Drug: Inavolisib
- Drug: Belvarafenib
- Drug: Pralsetinib
- Drug: GDC-6036
- Drug: Camonsertib
Inclusion Criteria:
- Histologically or cytologically confirmed diagnosisthe process of identifying a disease based on signs and symptoms, patient history and medical test results 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 Oncologythe study, diagnosis and treatment of cancer 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 cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs
- 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