Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study

Solid Tumors Clinical Trial

Official title:

Tumor-Agnostic Precision Immunooncology and Somatic Targeting Rational for You (TAPISTRY) Phase II Platform Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04589845
• Other study ID #: BO41932
• Secondary ID: 2020-001847-16
• Status: Recruiting
• Phase: Phase 2
• Start date: January 18, 2021
• Est. completion date: September 25, 2032

Study information

• Verified date: April 2024
• Source: Hoffmann-La Roche
• Contact: Reference Study ID Number: BO41932 https://forpatients.roche.com
• Phone: 888-662-6728 (U.S. and Canada)
• Email: Global-Roche-Genentech-Trials[@]gene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 920
• Est. completion date: September 25, 2032
• Est. primary completion date: September 25, 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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:

• 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

Related Conditions & MeSH terms

• Solid Tumors

Intervention

Drug:
• Entrectinib
Adults and pediatric participants with a BSA >/= 1.51 m2: entrectinib will be self-administered by participants orally at home at a dose of 600 mg/day (three 200-mg capsules per day). Pediatric participants with a BSA < 1.51 m2: entrectinib will be administered orally at home in mini-tablet formulation at a dose of 400 mg/day (BSA=1.11-1.50 m2) or 300 mg/day (BSA=0.81-1.10 m2) or 200 mg/day (BSA=0.51-0.80 m2) or 100 mg/day (BSA=0.43-0.50 m2).
• Entrectinib
Adults and pediatric participants with a BSA >/= 1.51 m2: entrectinib will be self-administered by participants orally at home at a dose of 600 mg/day (three 200-mg capsules per day). Pediatric participants with a BSA < 1.51 m2: entrectinib will be administered orally at home in mini-tablet formulation at a dose of 400 mg/day (BSA=1.11-1.50 m2) or 300 mg/day (BSA=0.81-1.10 m2) or 200 mg/day (BSA=0.51-0.80 m2) or 100 mg/day (BSA=0.43-0.50 m2).
• Alectinib
Alectinib will be administered orally BID (twice a day) with food at a dosage of 600 mg (four 150-mg capsules).
• Atezolizumab
Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg for participants aged >/=18 years, and 15 mg/kg (maximum 1200 mg) for participants aged <18 years on Day 1 of each 21-day cycle.
• Ipatasertib
For participants 12-17 years of age, ipatasertib will be administered at the starting dose of 200 mg for participants < 35 kg, 300 mg for participants >/= 35 and < 45 kg, 400 mg for those >/= 45 kg orally QD, beginning of Cycle 1, on Days 1-21 of each 28-day cycle until the participant experiences disease progression, intolerable toxicity, or withdraws consent.
• Trastuzumab emtansine
Trastuzumab emtansine will be administered at 3.6 mg/kg by IV infusion every 21 days until disease progression or unacceptable toxicity. The dosage and administration method also applies for pediatric participants 12-17 years of age.
• Idasanutlin
Idasanutlin will be administered at 250 mg QD (daily) PO for Days 1-5 of each 28-day cycle. Idasanutlin may be given without regard to meals and water can be given as often as necessary or desired. The daily doses should be administered 10-14 hours apart. Note: Cohort G has been closed for enrollment.
• Inavolisib
GDC-077 will be administered QD at a starting dose of 9 mg PO in repeated 28-day cycles. The dosage and administration method also applies for pediatric participants 12-17 years of age.
• Belvarafenib
Belvarafenib will be administered at a dose 400 mg (PO) BID with adequate water (more than 200 mL). One cycle consists of 28 days. Administration of belvarafenib should occur BID on every day of each 28-day cycle.
• Pralsetinib
Pralsetinib will be self-administered by participants orally at home (except on clinic days) on a continuous daily dosing regimen at a dose of 400 mg/day (four 100-mg capsules per day) for adult and pediatric patients = 12 and < 18 years of age. A treatment cycle consists of 4 weeks (28 days).
• GDC-6036
GDC-6036 will be self-administered by patients orally at home (except on clinic days) on a continuous daily dosing regimen for both adult and pediatric patients. A treatment cycle consists of 3 weeks (21 days).
• Camonsertib
Camonsertib will be self-administered by patients orally at home (except on clinic days). A treatment cycle consists of 3 weeks and will be given on days 1-3 and days 8-10 of every 21-day cycle.

Locations

Country	Name	City	State
Australia	Kinghorn Cancer Centre; St Vincents Hospital	Darlinghurst	New South Wales
Australia	Peter MacCallum Cancer Centre; Medical Oncology	Melbourne	Victoria
Australia	Royal Children's Hospital	Parkville	Victoria
Australia	Sydney Children's Hospital	Randwick	New South Wales
Australia	Royal Darwin Hospital; Alan Walker Cancer Centre	Tiwi	Northern Territory
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland
Belgium	Cliniques Universitaires St-Luc	Bruxelles
Belgium	GHdC Site Notre Dame	Charleroi
Belgium	UZ Antwerpen	Edegem
Belgium	UZ Gent	Gent
Belgium	UZ Leuven Gasthuisberg	Leuven
Brazil	Hospital Moinhos de Vento	Porto Alegre	RS
Brazil	Clínica Onco Star - Rede D'Or	Sao Paulo	SP
Brazil	Hospital A. C. Camargo; Oncologia	Sao Paulo	SP
Brazil	Hospital Sírio-Libanês	Sao Paulo	SP
Brazil	Hospital Sírio-Libanês	Sao Paulo	SP
Canada	London Health Sciences Centre · Victoria Hospital; Department of Medicine	London	Ontario
Canada	McGill University Health Center	Montreal	Quebec
Canada	The Ottawa Hospital - General Campus	Ottawa	Ontario
Canada	Princess Margaret Cancer Center	Toronto	Ontario
Canada	The Hospital for Sick Children	Toronto	Ontario
Canada	BC Cancer ? Vancouver	Vancouver	British Columbia
China	Beijing Cancer Hospital	Beijing
China	Beijing Children's Hospital, Capital Medical University; Oncological Surgery Department	Beijing City
China	Jilin Cancer Hospital	Changchun
China	The First Hospital of Jilin University	Changchun City
China	West China Hospital - Sichuan University	Chengdu City
China	Shanghai East Hospital	Shanghai
China	Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai
China	Zhongshan Hospital Fudan Unvierstiy	Shanghai City
China	Tianjin Cancer Hospital	Tianjin
China	First Affiliated Hospital of Medical College of Xi'an Jiaotong University	Xi'an
Denmark	Aarhus Universitetshospital; Kræftafdelingen	Aarhus N
Denmark	Rigshospitalet; Onkologisk Klinik	København Ø
France	Institut Bergonie; Oncologie	Bordeaux
France	Centre Oscar Lambret; Service de Pediatrie	Lille
France	CENTRE LEON BERARD; Département d?Hématologie et d?Oncologie	Lyon
France	Hopital de la Timone	Marseille
France	Institut Universitaire du Cancer de Toulouse-Oncopole	Toulouse
France	Institut de Cancerologie Gustave-Roussy (IGR)	Villejuif
Germany	Uniklinik Essen	Essen
Germany	Universitätsklinikum Freiburg Medizinische Klinik Innere Medizin I	Freiburg
Germany	Georg-August-Uniklinik ; Zentrum Innere Medizin Abt. Hämatologie & Onkologie	Göttingen
Germany	Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II	Hamburg
Germany	Medizinische Hochschule Zentrum Innere Medizin Abt.Gastroenterologie, Endokrinologie und Hepatologie	Hannover
Germany	SLK-Kliniken Heilbronn GmbH; Klinik für Innere Medizin III; Schwerpunkt Häma./Onko./Palliativm.	Heilbronn
Germany	Praxis für Hämatologie, Onkologie und Palliativmedizin	Mönchengladbach
Germany	Klinikum der Universität München, Campus Großhadern; Medizinische Klinik und Poliklinik III	München
Germany	Universtitätsklinikum Ulm; Klinik für Innere Medizin III	Ulm
Germany	Uniklinikum, Comprehensive Cancer Center Mainfranken; Interdisziplinäres Studienzentrum mit ECTU	Würzburg
Hong Kong	Hong Kong Children's Hospital	Hong Kong
Hong Kong	Prince of Wales Hospital; Department of Clinical Onocology	Shatin
Israel	Rambam Health Care Campus; Oncology	Haifa
Israel	Hadassah University Hospital - Ein Kerem	Jerusalem
Israel	Rabin MC; Davidof Center - Oncology Institute	Petach Tikva
Israel	Sheba Medical Center	Ramat Gan
Israel	Sourasky / Ichilov Hospital; Dept. of Oncology	Tel Aviv
Italy	Asst Degli Spedali Civili Di Brescia	Brescia	Lombardia
Italy	Azienda Ospedaliera Meyer; Centro di Eccellenza di Oncologia ed Ematologia Pediatrica	Firenze	Toscana
Italy	Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1	Milano	Lombardia
Italy	Istituto Nazionale Tumori di Milano; S.C. Oncologia Pediatrica	Milano	Lombardia
Italy	Istituto Nazionale Tumori Fondazione G. Pascale	Napoli	Campania
Italy	Ospedale Pediatrico Bambino Gesù - IRCCS; Dipartimento di Onco-Ematologia Pediatrica	Roma	Lazio
Italy	Policlinico Universitario Agostino Gemelli IRCCS; UOS Fase 1	Roma	Lazio
Italy	Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica	Siena	Toscana
Italy	Dipartimento di Scienze Pediatriche Adolescenza; Osp. Infantile Regina Margherita	Torino	Piemonte
Japan	National Cancer Center Hospital East	Chiba
Japan	Kindai University Hospital	Osaka
Japan	National Cancer Center Hospital	Tokyo
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center- Adult Site	Seoul
Korea, Republic of	Samsung Medical Center- Pediatric Site	Seoul
Korea, Republic of	Seoul National University Hospital- Adult Site	Seoul
Korea, Republic of	Seoul National University Hospital- Pediatric Site	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Netherlands	Prinses Maxima Centrum	Utrecht
New Zealand	Auckland City Hospital, Cancer and Blood Research	Auckland
New Zealand	Christchurch Hospital; Dept of Oncology	Christchurch
Poland	Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii	Gdansk
Poland	Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki Piers	Warszawa
Portugal	IPO do Porto; Servico de Oncologia Medica	Porto
Puerto Rico	PanOncology Trials; Hospital Oncológico, Puerto Rico Medical Center	San Juan
Singapore	National Cancer Centre; Medical Oncology	Singapore
Singapore	National University Hospital; National University Cancer Institute, Singapore (NCIS)	Singapore
South Africa	Medical Oncology Centre of Rosebank; Oncology	Johannesburg
Spain	Vall d?Hebron Institute of Oncology (VHIO), Barcelona	Barcelona
Spain	Hospital Sant Joan De Deu	Esplugues De Llobregas	Barcelona
Spain	Clinica Universidad de Navarra Madrid; Servicio de Oncología	Madrid
Spain	Hospital Infantil Universitario Nino Jesus	Madrid
Spain	Hospital Universitario 12 de Octubre; Servicio de Oncologia	Madrid
Spain	Hospital Universitario La Paz; Servicio de Oncologia	Madrid
Spain	START Madrid-FJD, Hospital Fundacion Jimenez Diaz	Madrid
Spain	START Madrid. Centro Integral Oncologico Clara Campal; CIOCC	Madrid
Spain	Hospital Univ Vall d'Hebron; Servicio de Oncologia	Sant Andreu de La Barca	Barcelona
Spain	Hospital Universitario la Fe; Servicio de Oncologia	Valencia
Switzerland	Universitätsspital Basel (USB)	Basel
Switzerland	Ospedale Regionale di Bellinzona Medizin Onkologie	Bellinzona
Switzerland	Inselspital, Klinik und Poliklinik für Medizinische Onkologie	Bern
Switzerland	Unversitätsspital Zürich	Zürich
Taiwan	Taichung Veterans General Hospital; Division of Hema-Oncology	Taichung
Taiwan	National Cheng Kung University Hospital; Oncology	Tainan
Taiwan	Taipei Veterans General Hospital; Department of Oncology	Taipei City
Taiwan	Chang Gung Memorial Hospital-Linkou; Dept of Oncology	Taoyuan County
Taiwan	National Taiwan University Hospital; Oncology	Zhongzheng Dist.
United Kingdom	Beatson West of Scotland Cancer Centre	Glasgow
United Kingdom	Guys and St Thomas NHS Foundation Trust, Guys Hospital	London
United Kingdom	University College London Hospital	London
United Kingdom	Royal Manchester Children?s Hospital	Manchester
United Kingdom	The Christie NHS Foundation Trust	Manchester
United States	University of New Mexico; Comprehensive Cancer Center	Albuquerque	New Mexico
United States	St. Joseph Mercy Hospital	Ann Arbor	Michigan
United States	University Cancer & Blood Center, LLC; Research	Athens	Georgia
United States	Children's Hospital Colorado; Center For Cancer/Blood Disorder	Aurora	Colorado
United States	Texas Onc-Central Austin CA Ct	Austin	Texas
United States	St. Vincent Frontier Cancer Center	Billings	Montana
United States	St. Alphonsus	Boise	Idaho
United States	Eastchester Center for Cancer Care	Bronx	New York
United States	Montefiore Einstein Center for Cancer Care	Bronx	New York
United States	Consultants in Medical Oncology and Hematology	Broomall	Pennsylvania
United States	Levine Cancer Institute	Charlotte	North Carolina
United States	Barrett Cancer Center	Cincinnati	Ohio
United States	Oncology Hematology Care Inc	Cincinnati	Ohio
United States	Mary Crowley Medical Research Center	Dallas	Texas
United States	Texas Oncology - Baylor Charles A. Sammons Cancer Center	Dallas	Texas
United States	Southern Cancer Center	Daphne	Alabama
United States	Henry Ford Health System	Detroit	Michigan
United States	City of Hope National Medical Center	Duarte	California
United States	New York Cancer and Blood Specialists - Setauket Medical Oncology	East Setauket	New York
United States	Cook Childrens Medical Center	Fort Worth	Texas
United States	University of Florida	Gainesville	Florida
United States	The West Clinic; West Cancer Center	Germantown	Tennessee
United States	Western Regional Medical Center at Cancer Treatment Centers of America	Goodyear	Arizona
United States	PRISMA Health - Greenville	Greenville	South Carolina
United States	Alliance Cancer Specialists	Horsham	Pennsylvania
United States	The University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Horizon Oncology Research, Inc.	Lafayette	Indiana
United States	Comprehensive Cancer Centers of Nevada - Eastern Avenue	Las Vegas	Nevada
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	Virginia Cancer Specialists - Leesburg	Leesburg	Virginia
United States	Kaiser Permanente Los Angeles; Clinic/Infusion -LA	Los Angeles	California
United States	USC Norris Cancer Center	Los Angeles	California
United States	St. Jude Children'S Research Hospital	Memphis	Tennessee
United States	Miami Cancer Institute of Baptist Health, Inc.	Miami	Florida
United States	Froedtert and The Medical College of Wisconsin	Milwaukee	Wisconsin
United States	University of Minnesota	Minneapolis	Minnesota
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	National Translational Research Group	New York	New York
United States	Christiana Care Health Srvcs; Helen F Graham Can Center	Newark	Delaware
United States	Hoag Memorial Hospital	Newport Beach	California
United States	Ocala Oncology Center	Ocala	Florida
United States	Nebraska Methodist Hospital; Cancer Center	Omaha	Nebraska
United States	Cancer Treatment Centers of America; Eastern Regional Medical Center	Philadelphia	Pennsylvania
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Providence Portland Medical Center	Portland	Oregon
United States	UC Davis Comprehensive Cancer Center	Sacramento	California
United States	Washington University	Saint Louis	Missouri
United States	Metro-Minnesota Community Oncology Research Consortium	Saint Louis Park	Minnesota
United States	University of California at San Francisco	San Francisco	California
United States	Sarcoma Oncology Center	Santa Monica	California
United States	New England Cancer Specialists	Scarborough	Maine
United States	Maryland Hematology & Oncology. P.A.	Silver Spring	Maryland
United States	Northwest Medical Specialties, PLLC; Research Department	Tacoma	Washington
United States	Texas Oncology- Northeast Texas	Tyler	Texas
United States	Midwestern Regional Med Center	Zion	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Brazil,  Canada,  China,  Denmark,  France,  Germany,  Hong Kong,  Israel,  Italy,  Japan,  Korea, Republic of,  Netherlands,  New Zealand,  Poland,  Portugal,  Puerto Rico,  Singapore,  South Africa,  Spain,  Switzerland,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All Cohorts: Independent Review Committee (IRC)-assessed objective response rate (ORR) based on confirmed objective response (OR) per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)	Confirmed objective response indicates >/= 4 weeks after initial documentation of response	Approximately up to 12 years
Secondary	All Cohorts: IRC-assessed duration of response (DOR) per RECIST v1.1		Approximately up to 12 years
Secondary	All Cohorts: IRC-assessed clinical benefit rate (CBR) per RECIST v1.1		Approximately up to 12 years
Secondary	All Cohorts: IRC-assessed progression free survival (PFS) per RECIST v1.1		Approximately up to 12 years
Secondary	All Cohorts: Investigator (INV)-assessed ORR per RECIST v1.1		Approximately up to 12 years
Secondary	All Cohorts: INV-assessed DOR per RECIST v1.1		Approximately up to 12 years
Secondary	All Cohorts: INV-assessed CBR per RECIST v1.1		Approximately up to 12 years
Secondary	All Cohorts: INV-assessed PFS per RECIST v1.1		Approximately up to 12 years
Secondary	All Cohorts: IRC- and INV-assessed time to central nervous system (CNS) progression per RECIST v1.1		Approximately up to 12 years
Secondary	All Cohorts: Overall Survival (OS)		Approximately up to 12 years
Secondary	Cohorts A, B, C, D, I, J, K: IRC-assessed CNS-ORR per Response Assessment in Neuro-Oncology (RANO)		Approximately up to 12 years
Secondary	Cohorts A, B, C, D, I, J, K: IRC-assessed CNS-DOR per RANO		Approximately up to 12 years
Secondary	Cohorts A, B, C, D, I, J, K: IRC-assessed CNS-CBR per RANO		Approximately up to 12 years
Secondary	Cohorts A, B, C, D, I, J, K: IRC-assessed CNS-PFS per RANO		Approximately up to 12 years
Secondary	Cohorts A, B, C, D, I, J, K: INV-assessed CNS-ORR per RANO		Approximately up to 12 years
Secondary	Cohorts A, B, C, D, I, J, K: INV-assessed CNS-DOR per RANO		Approximately up to 12 years
Secondary	Cohorts A, B, C, D, I, J, K: INV-assessed CNS-CBR per RANO		Approximately up to 12 years
Secondary	Cohorts A, B, C, D, I, J, K: INV-assessed CNS-PFS per RANO		Approximately up to 12 years
Secondary	Cohorts A, B, C, D, E, F, G, H, I, J, K, L, M, N: IRC-assessed ORR per International Neuroblastoma Response Criteria (INRC)		Approximately up to 12 years
Secondary	Cohorts A, B, C, D, E, F, G, H, I, J, K, L, M, N: KIRC-assessed DOR per INRC		Approximately up to 12 years
Secondary	Cohorts A, B, C, D, E, F, G, H, I, J, K, L, M, N: IRC-assessed CBR per INRC		Approximately up to 12 years
Secondary	Cohorts A, B, C, D, E, F, G, H, I, J, K, L, M, N: IRC-assessed PFS per INRC		Approximately up to 12 years
Secondary	Cohorts A, B, C, D, E, F, G, H, I, J, K, L, M, N: INV-assessed ORR per INRC		Approximately up to 12 years
Secondary	Cohorts A, B, C, D, E, F, G, H, I, J, K, L, M, N: INV-assessed DOR per INRC		Approximately up to 12 years
Secondary	Cohorts A, B, C, D, E, F, G, H, I, J, K, L, M, N: INV-assessed CBR per INRC		Approximately up to 12 years
Secondary	Cohorts A, B, C, D, E, F, G, H, I, J, K, L, M, N: INV-assessed PFS per INRC		Approximately up to 12 years
Secondary	All Cohorts: IRC-assessed ORR per RECIST v1.1 in participants with alteration/biomarker-positive circulating tumor DNA (ctDNA) by blood-based next-generation sequencing (NGS) assay		Approximately up to 12 years
Secondary	All Cohorts: IRC-assessed DOR per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay		Approximately up to 12 years
Secondary	All Cohorts: IRC-assessed CBR per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay		Approximately up to 12 years
Secondary	All Cohorts: IRC-assessed PFS per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay		Approximately up to 12 years
Secondary	All Cohorts: INV-assessed ORR per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay		Approximately up to 12 years
Secondary	All Cohorts: INV-assessed DOR per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay		Approximately up to 12 years
Secondary	All Cohorts: INV-assessed CBR per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay		Approximately up to 12 years
Secondary	All Cohorts: INV-assessed PFS per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay		Approximately up to 12 years
Secondary	Cohorts A, B, C, D, I, J, K: IRC-assessed intracranial (IC)-ORR per RECIST v1.1		Approximately up to 12 years
Secondary	Cohorts A, B, C, D, I, J, K: IRC-assessed IC-DOR per RECIST v1.1		Approximately up to 12 years
Secondary	Cohorts A, B, C, D, I, J, K: IRC-assessed IC-CBR per RECIST v1.1		Approximately up to 12 years
Secondary	Cohorts A, B, C, D, I, J, K: IRC-assessed IC-PFS rate per RECIST v1.1		Approximately up to 12 years
Secondary	Cohorts A, B, C, D, I, J, K: INV-assessed IC-ORR per RECIST v1.1		Approximately up to 12 years
Secondary	Cohorts A, B, C, D, I, J, K: INV-assessed IC-DOR per RECIST v1.1		Approximately up to 12 years
Secondary	Cohorts A, B, C, D, I, J, K: INV-assessed IC-CBR per RECIST v1.1		Approximately up to 12 years
Secondary	Cohorts A, B, C, D, I, J, K: INV-assessed IC-PFS rate per RECIST v1.1		Approximately up to 12 years
Secondary	All Cohorts: Percentage of participants with confirmed deterioration as assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30)	The EORTC QLQ-C30 is a validated, reliable self-report measure. It consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), eight symptom scales (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea) and global health/quality of life, with a recall period of the previous week. Scale scores can be obtained for the multi-item scales using rating scales of 4 or 7 points.	Approximately up to 12 years
Secondary	All Cohorts: Change from Baseline in the EORTC-QLQ-C30 total score		Approximately up to 12 years
Secondary	All Cohorts: Percentage of participants with a clinical meaningful change on the Global Health Status, Physical Functioning, and Role Functioning scores from the EORTC QLQ-C30		Approximately up to 12 years
Secondary	All Cohorts: Time to confirmed symptom onset or worsening from tumor-related symptom scores from the EORTC QLQ-C30 and EORTC Item Library	The EORTC Item library includes stand-alone symptoms scales and an overall assessment of treatment bother to provide additional information not currently captured in the EORTC QLQ-C30. The scales use the same rating scale and recall period of previous week as the symptom scales in the EORTC QLQ-C30.	Approximately up to 12 years
Secondary	All Cohorts: Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)	Adverse event severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5 (NCI CTCAE v5.0.)	Approximately up to 12 years
Secondary	Cohorts A, B: Plasma concentration of entrectinib at specified timepoints		Day 1 of Cycle 1-6 and Day 1 of every other Cycle going forward (one Cycle=28 days)
Secondary	Cohort C: Plasma concentration of alectinib at specified timepoints		Cycle 1, Day 1 and Day 15; Day 1 of Cycle 2-6, and Day 1 of every other Cycle going forward (one Cycle=28 days)
Secondary	Cohort D: Plasma concentration of atezolizumab at specified timepoints		Day 1 of Cycle 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, and every even Cycles thereafter (one Cycle=21 days)
Secondary	Cohort E: Plasma concentration of ipatasertib at specified timepoints		Cycle 1, Day 1 and 15; Cycle 2, Day 1; Cycle 3, Day 15; Cycle 4, Day 1, and every even Cycle thereafter (one Cycle=28 days)
Secondary	Cohort F: Serum concentration of trastuzumab emtansine at specified timepoints		Cycle 1, Day 1; Cycle 2, Day 1; Cycle 4, Day 1; Cycle 6, Day 1, and every even Cycle thereafter (one Cycle=21 days)
Secondary	Cohort G: Plasma concentration of idasanutlin at specified timepoint		Cycle 1, Day 1, 2, 5, 8; Cycle 2, Day 1, 2, 5; Cycle 3, Day 2, 5; Cycle 4, Day 1, and every other Cycle going forward (one Cycle=28 days)
Secondary	Cohort H: Plasma concentration of GDC-0077 at specified timepoints		Cycle 1, Day 1, 8 (+/-1 day), 15 (+/-1 day); Cycle 2, Day 1 (+/-1 day); Day 1 of Cycle 4, and every other even Cycle going forward (one Cycle=28 days)
Secondary	Cohort L: Plasma concentration of GDC-6036 at specified timepoints		Cycle 1: Day 1, 15; Cycles 2-5, Day 1, Cycle 7, Day 1 and every other cycle until post 1-year of treatment (Day of Cycles 7, 9, 11) (Cycle=21 days))
Secondary	Cohort M: Plasma concentration of Camonsertib at specified timepoints		Cycle 1, Day 1, 2, 8; Cycle 2-4, Day 1; Cycle 5, Day 1, and every odd cycle until post 1-year of treatment (Cycles 7, 9, 11, and 13) (Cycle=21 days))
Secondary	Cohort N: Plasma concentration of Camonsertib at specified timepoints		Cycle 1, Day 1, 2, 8; Cycle 2-4, Day 1; Cycle 5, Day 1, and every odd cycle until post 1-year of treatment (Cycles 7, 9, 11, and 13) (Cycle=21 days))
Secondary	Cohorts D, F: Percentage of participants with anti-drug antibodies (ADA)		Cohort D: Day 1 of Cycle 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, and every even Cycles thereafter (one Cycle=21 days); Cohort F: Cycle 1, Day 1; Cycle 2, Day 1; Cycle 4, Day 1; Cycle 6, Day 1, and every even Cycle thereafter (one Cycle=21 days)