A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)

A Phase I/Ib Global, Multicenter, Open-label Umbrella Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)

This open-label, exploratory study is designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or combinations, in participants with metastatic colorectal cancer (mCRC) whose tumors are biomarker positive as per treatment arm-specific definition. Eligible participants with mCRC will be enrolled into specific treatment arms based on their biomarker assay results.

Study Overview

• Status: Recruiting
• Conditions: Metastatic Colorectal Cancer
• Intervention / Treatment: Drug: Inavolisib; Drug: Cetuximab; Drug: Bevacizumab; Drug: Atezolizumab; Drug: Tiragolumab; Drug: SY-5609; Drug: FOLFOX; Drug: Divarasib; Drug: FOLFIRI; Diagnostic test: FoundationOne®Liquid CDx

• Study Type: Interventional
• Enrollment (Estimated): 542
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Reference Study ID Number: WO42758 https://forpatients.roche.com/; Phone Number: 888-662-6728 (U.S. and Canada); Email: global-roche-genentech-trials@gene.com

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3000
      • Recruiting
      • Peter MacCallum Cancer Centre
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X6
      • Active, not recruiting
      • Princess Margaret Cancer Center
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Withdrawn
      • Jewish General Hospital
    • Montreal, Quebec, Canada, H4A 3J1
      • Withdrawn
      • McGill University Health Center
• Denmark
  • København Ø, Denmark, 2100
    • Recruiting
    • Rigshospitalet, Onkologisk Klinik
• Germany
  • Berlin, Germany, 13353
    • Recruiting
    • Charité Universitätsmedizin Berlin
  • Bochum, Germany, 44791
    • Recruiting
    • Katholisches Klinikum Bochum gGmbH - St. Josef-Hospital
  • Dresden, Germany, 01307
    • Recruiting
    • Universitätsklinik Carl Gustav Carus der Technischen Universität Dresden
  • Düsseldorf, Germany, 40225
    • Recruiting
    • Universitätsklinikum Düsseldorf
  • Hamburg, Germany, 22763
    • Recruiting
    • Asklepios Klinik Altona
  • Heilbronn, Germany, 74078
    • Recruiting
    • SLK-Kliniken Heilbronn GmbH;Klinik für Innere Medizin III
  • München, Germany, 81377
    • Withdrawn
    • Klinikum der Universität München, Campus Großhadern
  • Ulm, Germany, 89081
    • Recruiting
    • Universitätsklinikum Ulm
• Italy
  • Campania
    • Naples, Campania, Italy, 80131
      • Recruiting
      • Università degli studi della Campania Luigi Vanvitelli
  • Emilia-Romagna
    • Meldola, Emilia-Romagna, Italy, 47014
      • Recruiting
      • Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS
  • Lazio
    • Rome, Lazio, Italy, 00168
      • Recruiting
      • Policlinico Universitario Agostino Gemelli IRCCS
  • Lombardy
    • Milan, Lombardy, Italy, 20133
      • Recruiting
      • Irccs Istituto Nazionale Dei Tumori (Int)
    • Milan, Lombardy, Italy, 20162
      • Recruiting
      • Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)
  • Veneto
    • Padova, Veneto, Italy, 35128
      • Recruiting
      • IRCCS Istituto Oncologico Veneto (IOV)
• Poland
  • Gdansk, Poland, 80-952
    • Recruiting
    • Uniwersyteckie Centrum Kliniczne, O?rodek Bada? Klinicznych Wczesnych Faz
  • Krakow, Poland, 30-688
    • Suspended
    • Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii
  • Poznan, Poland, 60-569
    • Recruiting
    • Uniwersytecki Szpital Kliniczny W Poznaniu
  • Warsaw, Poland, 02-781
    • Suspended
    • Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie
• South Korea
  • Goyang-si, South Korea, 10408
    • Recruiting
    • National Cancer Center
  • Jeollanam-do, South Korea, 58128
    • Recruiting
    • Chonnam National University Hwasun Hospital
  • Seongnam-si, South Korea, 13605
    • Recruiting
    • Seoul National University Bundang Hospital
  • Seoul, South Korea, 05505
    • Recruiting
    • Asan Medical Center
  • Seoul, South Korea, 03080
    • Recruiting
    • Seoul National University Hospital
  • Seoul, South Korea, 03722
    • Recruiting
    • Severance Hospital, Yonsei University Health System
  • Seoul, South Korea, (0)6351
    • Recruiting
    • Samsung Medical Center
• Spain
  • Barcelona, Spain, 08035
    • Recruiting
    • Vall d'Hebron Institute of Oncology (VHIO), Barcelona
  • Madrid, Spain, 28040
    • Recruiting
    • START Madrid-FJD, Hospital Fundacion Jimenez Diaz
  • Madrid, Spain, 28050
    • Withdrawn
    • START Madrid. Centro Integral Oncologico Clara Campal
  • Valencia, Spain, 46010
    • Recruiting
    • Hospital Clinico Universitario de Valencia
  • Zaragoza, Spain, 50009
    • Recruiting
    • Hospital Clinico Universitario Lozano Blesa
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Recruiting
      • Hospital Universitario Puerta de Hierro - Majadahonda
• Taiwan
  • Tainan, Taiwan, 00704
    • Recruiting
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 112201
    • Recruiting
    • Taipei Veterans General Hospital
  • Zhongzheng Dist., Taiwan, 10048
    • Recruiting
    • National Taiwan University Hospital
• United Kingdom
  • Cambridge, United Kingdom, CB2 0QQ
    • Recruiting
    • Addenbrookes Hospital
  • Cardiff, United Kingdom, CF14 2TL
    • Recruiting
    • Velindre Cancer Centre
  • London, United Kingdom, W2 1NY
    • Recruiting
    • Imperial College Healthcare NHS Trust
  • London, United Kingdom, W1G 6AD
    • Recruiting
    • Sarah Cannon Research Institute
  • London, United Kingdom, NW3 2QG
    • Withdrawn
    • Royal Free Hospital
  • London, United Kingdom, SW3 6JJ
    • Recruiting
    • Royal Marsden Hospital;Dept of Med-Onc
  • Manchester, United Kingdom, M20 4BX
    • Recruiting
    • The Christie NHS Foundation Trust
  • Sutton, United Kingdom, SM2 5PT
    • Recruiting
    • Royal Marsden Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Withdrawn
      • UAB Comprehensive Cancer Center
  • Arizona
    • Phoenix, Arizona, United States, 85259
      • Completed
      • Mayo Clinic Arizona
  • California
    • Duarte, California, United States, 91010
      • Active, not recruiting
      • City of Hope Comprehensive Cancer Center
    • Encinitas, California, United States, 92024
      • Withdrawn
      • cCare
    • Los Angeles, California, United States, 90095
      • Recruiting
      • UCLA
    • Los Angeles, California, United States, 90048
      • Active, not recruiting
      • Cedars-Sinai Medical Center
    • Los Angeles, California, United States, 90033
      • Completed
      • USC Norris Cancer Center
    • Newport Beach, California, United States, 92663
      • Withdrawn
      • Hoag Memorial Hospital Presbyterian
    • Stanford, California, United States, 94305-5820
      • Completed
      • Stanford Cancer Center
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Active, not recruiting
      • University of Colorado Cancer Center
    • Lone Tree, Colorado, United States, 80124
      • Recruiting
      • Rocky Mountain Cancer Centers, LLP
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Recruiting
      • Yale Cancer Center
    • Norwich, Connecticut, United States, 06360
      • Withdrawn
      • Eastern Ct Hema/Onco Assoc
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Withdrawn
      • Mayo Clinic in Florida
    • Tampa, Florida, United States, 33612
      • Active, not recruiting
      • Moffitt Cancer Center
  • Illinois
    • Arlington Heights, Illinois, United States, 60005
      • Recruiting
      • Illinois Cancer Specialists
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Recruiting
      • Mary Bird Perkins Cancer Ctr
  • Massachusetts
    • Boston, Massachusetts, United States, 02114-2621
      • Completed
      • Massachusetts General Hospital
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Withdrawn
      • Karmanos Cancer Institute
  • Minnesota
    • Rochester, Minnesota, United States, 55902
      • Recruiting
      • Mayo Clinic Rochester
  • New York
    • New Hyde Park, New York, United States, 11042-1116
      • Recruiting
      • New York Cancer & Blood Specialists - New Hyde Park
    • New York, New York, United States, 10028
      • Recruiting
      • New York Cancer and Blood Specialists-Central Park Hematology & Oncology
    • Port Jefferson Station, New York, United States, 11776
      • Recruiting
      • New York Cancer & Blood Specialists
    • The Bronx, New York, United States, 10469-5930
      • Recruiting
      • New York Cancer & Blood Specialists - Bronx
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Completed
      • Duke University Medical Center
  • Oregon
    • Salem, Oregon, United States, 97301
      • Active, not recruiting
      • Hematology Oncology Salem
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • Active, not recruiting
      • UPMC - Hillman Cancer Center
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Completed
      • Vanderbilt University Medical Center
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • SCRI Oncology Partners
    • Nashville, Tennessee, United States, 37203
      • Completed
      • Sarah Cannon Research Institute / Tennessee Oncology
  • Texas
    • Denton, Texas, United States, 76201
      • Recruiting
      • Texas Oncology - Northeast Texas
    • Kingwood, Texas, United States, 77339
      • Withdrawn
      • Lumi Research
    • Webster, Texas, United States, 77598-4420
      • Recruiting
      • Texas Oncology - Gulf Coast
  • Washington
    • Seattle, Washington, United States, 98104
      • Completed
      • Swedish Cancer Inst.
    • Spokane, Washington, United States, 99208
      • Withdrawn
      • Medical Oncology Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

• Signed cohort-specific Informed Consent Form
• Age >= 18 years at time of signing Informed Consent Form

• Biomarker eligibility as determined by:

  • A validated test approved by local health authorities for detection of the specified biomarkers/mutations.
  • A validated test performed at a College of American Pathologists/clinical laboratory improvement amendments (CAP/CLIA) -certified or equivalently accredited diagnostic laboratory using a validated test for detection of the specified biomarkers.
  • Prior test results completed before signing cohort-specific Informed Consent Form or local test results generated prior to or during screening, and availability of a full report of the testing results OR
  • Blood-based FoundationOne Liquid CDx biomarker eligibility test result generated prior to or during screening or, in case of re-enrollment after treatment discontinuation, prior to starting a new anti-cancer therapy.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of <= 1
• Life expectancy >= 3 months, as determined by the investigator
• Histologically confirmed adenocarcinoma originating from the colon or rectum
• Metastatic disease
• Prior therapies for metastatic disease
• Ability to comply with the study protocol, in the investigators judgment
• Measurable disease (at least one target lesion) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
• Baseline tumor tissue samples will be collected from all participants for exploratory biomarker research
• Adequate hematologic and organ function within 14 days prior to initiation of study treatment
• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures
• For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm

Exclusion Criteria

• Current participation or enrollment in another interventional clinical trial. Participants who are participating in the follow-up period of an interventional clinical trial are eligible for the study.
• Any systemic anti-cancer treatment within 2 weeks or 5 half-lives (whichever is shorter) prior to start of study treatment
• Treatment with investigational therapy within 28 days prior to initiation 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 patient's safe participation in and completion of the study or confounds the ability to interpret data from the study
• Severe infection within 4 weeks prior to initiation of study treatment or any active infection that, in the opinion of the investigator, could impact patient safety
• 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
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
• Uncontrolled tumor-related pain
• Uncontrolled or symptomatic hypercalcemia
• Clinically significant and active liver disease
• Negative HIV test at screening, with the following exception: Participants with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy for at least 4 weeks, have a CD4 count greater than or equal to 200/uL, have an undetectable viral load, and have not had a history of opportunistic infection attributable to AIDS within the last 12 months.
• Symptomatic, untreated, or actively progressing CNS metastases
• History of leptomeningeal disease or carcinomatous meningitis
• History of malignancy other than CRC within 2 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
• Any other disease, unresolved toxicity from prior therapy, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the participant at high risk from treatment complications
• Requirement for treatment with any medicinal product that contraindicates the use of any of the study treatments, may interfere with the planned treatment, affects participant compliance, or puts the patient at higher risk for treatment-related complications

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Atezolizumab + Tiragolumab + Bevacizumab; Participants in this randomized cohort will receive 1200 mg of atezolizumab by IV infusion on Day 1 of each cycle, combined with tiragolumab at a dose of 600 mg IV infusion on Day 1 of each cycle and bevacizumab IV infusion at a dose of 15 mg/kg on Day 1 of each cycle. (Cycle length=21 days) This arm is active, and not recruiting participants.	Drug: Bevacizumab; Bevacizumab IV will be administered as per schedule specified in the respective arm.; Other Names: Avastin; Drug: Atezolizumab; Atezolizumab IV infusion will be administered as per schedule specified in the respective arm.; Other Names: Tecentriq; Drug: Tiragolumab; Tiragolumab IV infusion will be administered as per schedule specified in the respective arm.; Diagnostic test: FoundationOne®Liquid CDx; FoundationOne®Liquid CDx is used to identify presence of genomic alterations for participant cohort assignment.
Experimental: Atezolizumab + Tiragolumab; Participants in this randomized cohort will receive 1200 mg of atezolizumab by IV infusion on Day 1 of each cycle combined with tiragolumab 600 mg IV infusion on Day 1 of each cycle. (Cycle length=21 days) This arm is active, and not recruiting participants.	Drug: Atezolizumab; Atezolizumab IV infusion will be administered as per schedule specified in the respective arm.; Other Names: Tecentriq; Drug: Tiragolumab; Tiragolumab IV infusion will be administered as per schedule specified in the respective arm.; Diagnostic test: FoundationOne®Liquid CDx; FoundationOne®Liquid CDx is used to identify presence of genomic alterations for participant cohort assignment.
Experimental: Atezolizumab + SY-5609; Participants will receive 1680 mg of atezolizumab by IV infusion on Day 1 of each cycle Q4W in repeated 28-day cycles combined with SY-5609 at a dose of 3, 4, 5, 6, 7 or 10 mg by mouth for 7 days, followed by 7 days off. (Cycle length=28 days) This arm is closed.	Drug: Atezolizumab; Atezolizumab IV infusion will be administered as per schedule specified in the respective arm.; Other Names: Tecentriq; Drug: SY-5609; SY-5609 will be administered by mouth as per schedule specified in the respective arm.; Diagnostic test: FoundationOne®Liquid CDx; FoundationOne®Liquid CDx is used to identify presence of genomic alterations for participant cohort assignment.
Experimental: Divarasib + Cetuximab + FOLFOX; Participants will receive cetuximab IV 500 mg/m2 body surface area on Days 1 and 15 and FOLFOX on Days 1 and 15 with divarasib PO QD on Days 1-28. (Cycle length=28 days) This arm is recruiting participants.	Drug: Cetuximab; Cetuximab IV will be administered as per schedule specified in the respective arm.; Drug: FOLFOX; FOLFOX (5-fluorouracil, leucovorin, oxaliplatin) IV will be administered as per schedule specified in the respective arm.; Drug: Divarasib; Divarasib will be administered orally as per schedule specified in the respective arms.; Other Names: GDC-6036; Diagnostic test: FoundationOne®Liquid CDx; FoundationOne®Liquid CDx is used to identify presence of genomic alterations for participant cohort assignment.
Experimental: Divarasib + Cetuximab; Participants will receive cetuximab IV 500 mg/m2 body surface area on Days 1 and 15 with divarasib PO QD on Days 1-28. (Cycle length=28 days) This arm is active, and not recruiting participants.	Drug: Cetuximab; Cetuximab IV will be administered as per schedule specified in the respective arm.; Drug: Divarasib; Divarasib will be administered orally as per schedule specified in the respective arms.; Other Names: GDC-6036; Diagnostic test: FoundationOne®Liquid CDx; FoundationOne®Liquid CDx is used to identify presence of genomic alterations for participant cohort assignment.
Experimental: Divarasib + Cetuximab + FOLFIRI; Participants will receive cetuximab IV 500 mg/m2 body surface area on Days 1 and 15 and FOLFIRI on Days 1 and 15 with divarasib PO QD on Days 1-28. (Cycle length=28 days) This arm is active, and not recruiting participants.	Drug: Cetuximab; Cetuximab IV will be administered as per schedule specified in the respective arm.; Drug: Divarasib; Divarasib will be administered orally as per schedule specified in the respective arms.; Other Names: GDC-6036; Drug: FOLFIRI; FOLFIRI (leucovorin, 5-fluorouracil, irinotecan) IV will be administered as per schedule specified in the respective arm.; Diagnostic test: FoundationOne®Liquid CDx; FoundationOne®Liquid CDx is used to identify presence of genomic alterations for participant cohort assignment.
Experimental: Divarasib + Bevacizumab + FOLFOX; Participants will receive Bevacizumab 5 mg/kg by IV infusion on Days 1 and 15 and FOLFOX on Days 1 and 15 with Divarasib PO QD on Days 1-28. (Cycle length=28 days) This arm is recruiting participants.	Drug: Bevacizumab; Bevacizumab IV will be administered as per schedule specified in the respective arm.; Other Names: Avastin; Drug: FOLFOX; FOLFOX (5-fluorouracil, leucovorin, oxaliplatin) IV will be administered as per schedule specified in the respective arm.; Drug: Divarasib; Divarasib will be administered orally as per schedule specified in the respective arms.; Other Names: GDC-6036; Diagnostic test: FoundationOne®Liquid CDx; FoundationOne®Liquid CDx is used to identify presence of genomic alterations for participant cohort assignment.
Experimental: Divarasib + Bevacizumab + FOLFIRI; Participants will receive Bevacizumab 5 mg/kg by IV infusion on Days 1 and 15 and FOLFIRI on Days 1 and 15 with Divarasib PO QD on Days 1-28. (Cycle length=28 days) This arm is recruiting participants.	Drug: Bevacizumab; Bevacizumab IV will be administered as per schedule specified in the respective arm.; Other Names: Avastin; Drug: Divarasib; Divarasib will be administered orally as per schedule specified in the respective arms.; Other Names: GDC-6036; Drug: FOLFIRI; FOLFIRI (leucovorin, 5-fluorouracil, irinotecan) IV will be administered as per schedule specified in the respective arm.; Diagnostic test: FoundationOne®Liquid CDx; FoundationOne®Liquid CDx is used to identify presence of genomic alterations for participant cohort assignment.
Experimental: Inavolisib + Cetuximab; Participants will receive 9 milligrams (mg) of inavolisib by mouth once daily (QD) on Days 8-28 of Cycle 1, then QD on Days 1-28 from Cycle 2 onwards (1 cycle=28 days). Participants will also receive cetuximab intravenous (IV) infusion 400 mg/m2 body surface area on Day 1 of Cycle 1. All subsequent weekly (QW) doses will be 250 mg/m2 each. This arm is closed.	Drug: Inavolisib; Inavolisib will be administered orally as per schedule specified in the respective arms.; Drug: Cetuximab; Cetuximab IV will be administered as per schedule specified in the respective arm.; Diagnostic test: FoundationOne®Liquid CDx; FoundationOne®Liquid CDx is used to identify presence of genomic alterations for participant cohort assignment.
Experimental: Inavolisib + Bevacizumab; Participants will receive 9 mg of inavolisib by mouth QD combined with bevacizumab 15 milligram/kilogram (mg/kg) IV once every three weeks (Q3W) on Day 1 of each cycle (1 cycle=21 days). This arm is closed.	Drug: Inavolisib; Inavolisib will be administered orally as per schedule specified in the respective arms.; Drug: Bevacizumab; Bevacizumab IV will be administered as per schedule specified in the respective arm.; Other Names: Avastin; Diagnostic test: FoundationOne®Liquid CDx; FoundationOne®Liquid CDx is used to identify presence of genomic alterations for participant cohort assignment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate	Defined as the proportion of participants with a complete response or partial response, as determined by the investigator according to RECIST v1.1	Approximately 84 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Response	Defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1	Approximately 84 months
Disease Control Rate	Defined as the proportion of participants with stable disease, or a complete or partial response, as determined by the investigator according to RECIST v1.1	Approximately 84 months
Percentage of Participants with Adverse Events (AEs)	Percentage of participants with adverse events.	Approximately 84 months
Plasma Concentrations of Divarasib	Plasma concentration of divarasib for divarasib + cetuximab + FOLFOX, divarasib + cetuximab, and divarasib + cetuximab+ FOLFIRI, Divarasib + Bevacizumab + FOLFOX, Divarasib + Bevacizumab + FOLFIRI treatment arms.	At pre-defined intervals from first administration of study drug up to approximately 84 months
Recommended Dose of Divarasib in Combination with Bevacizumab and FOLFOX	Recommended dose of divarasib in combination with bevacizumab and FOLFOX based on the totality of safety, efficacy and PK data.	Approximately 84 months
Recommended Dose of Divarasib in Combination with Bevacizumab and FOLFIRI	Recommended dose of divarasib in combination with bevacizumab and FOLFIRI based on the totality of safety, efficacy and PK data.	Approximately 84 months

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2021
• Primary Completion (Estimated): August 31, 2030
• Study Completion (Estimated): August 31, 2030

Study Registration Dates

• First Submitted: June 11, 2021
• First Submitted That Met QC Criteria: June 11, 2021
• First Posted (Actual): June 18, 2021

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: KRAS G12C
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Bevacizumab; Cetuximab; atezolizumab; Tiragolumab; inavolisib; Folfox protocol; IFL protocol; SY-5609
• Other Study ID Numbers: WO42758; 2021-001207-33 (EudraCT Number); 2023-505163-37-00 (Other Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No