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Metastatic Colorectal CancerPhase 1NCT04929223

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

A Phase 1 study testing Inavolisib, Bevacizumab and Cetuximab in people with Metastatic Colorectal Cancer, run by Hoffmann-La Roche at 84 sites in 11 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Colorectal Cancer
What is being tested?
Inavolisib, Bevacizumab and Cetuximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
542 participants
Where
84 sitesin 11 countries
Study dates
22 Oct 2021to 31 Aug 2030
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 18Show fewer
  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

84 sites in 11 countries. Contact the study team or a site near you to ask about taking part.

Reference Study ID Number: WO42758 https://forpatients.roche.com/ No attachments to email below. contact

888-662-6728 (U.S. and Canada)

global-roche-genentech-trials@gene.com

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact

84 sites in 11 countries

United States35 sites, 17 recruiting

  • Illinois Cancer Specialists

    Arlington Heights, Illinois, 60005

    Recruiting

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045

    Recruiting

  • Mary Bird Perkins Cancer Ctr

    Baton Rouge, Louisiana, 70809

    Recruiting

  • UAB Comprehensive Cancer Center

    Birmingham, Alabama, 35233

    Withdrawn

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114-2621

    Completed

  • Texas Oncology - Northeast Texas

    Denton, Texas, 76201

    Recruiting

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

    Withdrawn

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

    Recruiting

  • Duke University Medical Center

    Durham, North Carolina, 27710

    Completed

  • cCare

    Encinitas, California, 92024

    Withdrawn

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224

    Completed

  • Lumi Research

    Kingwood, Texas, 77339

    Withdrawn

  • Rocky Mountain Cancer Centers, LLP

    Lone Tree, Colorado, 80124

    Recruiting

  • USC Norris Cancer Center

    Los Angeles, California, 90033

    Completed

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

    Recruiting

  • UCLA

    Los Angeles, California, 90095

    Recruiting

  • Sarah Cannon Research Institute / Tennessee Oncology

    Nashville, Tennessee, 37203

    Completed

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

    Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

    Completed

  • Yale Cancer Center

    New Haven, Connecticut, 06520

    Recruiting

  • New York Cancer & Blood Specialists - New Hyde Park

    New Hyde Park, New York, 11042-1116

    Recruiting

  • New York Cancer and Blood Specialists-Central Park Hematology & Oncology

    New York, New York, 10028

    Recruiting

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663

    Withdrawn

  • Eastern Ct Hema/Onco Assoc

    Norwich, Connecticut, 06360

    Withdrawn

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85259

    Active, not recruiting

  • UPMC - Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

    Active, not recruiting

  • New York Cancer & Blood Specialists

    Port Jefferson Station, New York, 11776

    Recruiting

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55902

    Recruiting

  • Hematology Oncology Salem

    Salem, Oregon, 97301

    Completed

  • Swedish Cancer Inst.

    Seattle, Washington, 98104

    Completed

  • Medical Oncology Associates

    Spokane, Washington, 99208

    Withdrawn

  • Stanford Cancer Center

    Stanford, California, 94305-5820

    Completed

  • Moffitt Cancer Center

    Tampa, Florida, 33612

    Recruiting

  • New York Cancer & Blood Specialists - Bronx

    The Bronx, New York, 10469-5930

    Recruiting

  • Texas Oncology - Gulf Coast

    Webster, Texas, 77598-4420

    Recruiting

Other trials in United States

Germany8 sites, 7 recruiting

  • Charité Universitätsmedizin Berlin

    Berlin, 13353

    Recruiting

  • Katholisches Klinikum Bochum gGmbH - St. Josef-Hospital

    Bochum, 44791

    Recruiting

  • Universitätsklinik Carl Gustav Carus der Technischen Universität Dresden

    Dresden, 01307

    Recruiting

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40225

    Recruiting

  • Asklepios Klinik Altona

    Hamburg, 22763

    Recruiting

  • SLK-Kliniken Heilbronn GmbH;Klinik für Innere Medizin III

    Heilbronn, 74078

    Recruiting

  • Klinikum der Universität München, Campus Großhadern

    München, 81377

    Withdrawn

  • Universitätsklinikum Ulm

    Ulm, 89081

    Recruiting

Other trials in Germany

United Kingdom8 sites, 7 recruiting

  • Addenbrookes Hospital

    Cambridge, CB2 0QQ

    Recruiting

  • Velindre Cancer Centre

    Cardiff, CF14 2TL

    Recruiting

  • Royal Free Hospital

    London, NW3 2QG

    Withdrawn

  • Royal Marsden Hospital;Dept of Med-Onc

    London, SW3 6JJ

    Recruiting

  • Sarah Cannon Research Institute

    London, W1G 6AD

    Recruiting

  • Imperial College Healthcare NHS Trust

    London, W2 1NY

    Recruiting

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

    Recruiting

  • Royal Marsden Hospital

    Sutton, SM2 5PT

    Recruiting

Other trials in United Kingdom

South Korea7 sites, 7 recruiting

  • National Cancer Center

    Goyang-si, 10408

    Recruiting

  • Chonnam National University Hwasun Hospital

    Jeollanam-do, 58128

    Recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si, 13605

    Recruiting

  • Samsung Medical Center

    Seoul, (0)6351

    Recruiting

  • Seoul National University Hospital

    Seoul, 03080

    Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

    Recruiting

  • Asan Medical Center

    Seoul, 05505

    Recruiting

Other trials in South Korea

Spain7 sites, 6 recruiting

  • Vall d'Hebron Institute of Oncology (VHIO), Barcelona

    Barcelona, 08035

    Recruiting

  • Hospital Universitario de Donostia

    Donostia / San Sebastian, Guipuzcoa, 20080

    Recruiting

  • START Madrid-FJD, Hospital Fundacion Jimenez Diaz

    Madrid, 28040

    Recruiting

  • START Madrid. Centro Integral Oncologico Clara Campal

    Madrid, 28050

    Withdrawn

  • Hospital Universitario Puerta de Hierro - Majadahonda

    Majadahonda, Madrid, 28222

    Recruiting

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010

    Recruiting

  • Hospital Clinico Universitario Lozano Blesa

    Zaragoza, 50009

    Recruiting

Other trials in Spain

Italy6 sites, 5 recruiting

  • Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS

    Meldola, Emilia-Romagna, 47014

    Recruiting

  • Irccs Istituto Nazionale Dei Tumori (Int)

    Milan, Lombardy, 20133

    Withdrawn

  • Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)

    Milan, Lombardy, 20162

    Recruiting

  • Università degli Studi della Campania Luigi Vanvitelli

    Naples, Campania, 80131

    Recruiting

  • IRCCS Istituto Oncologico Veneto (IOV)

    Padova, Veneto, 35128

    Recruiting

  • Policlinico Universitario Agostino Gemelli IRCCS

    Rome, Lazio, 00168

    Recruiting

Other trials in Italy

Poland4 sites, 2 recruiting

  • Uniwersyteckie Centrum Kliniczne, O?rodek Bada? Klinicznych Wczesnych Faz

    Gdansk, 80-952

    Recruiting

  • Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii

    Krakow, 30-688

    Suspended

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Poznan, 60-569

    Recruiting

  • Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie

    Warsaw, 02-781

    Suspended

Other trials in Poland

Canada3 sites

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

    Withdrawn

  • McGill University Health Center

    Montreal, Quebec, H4A 3J1

    Withdrawn

  • Princess Margaret Cancer Center

    Toronto, Ontario, M5G 1X6

    Active, not recruiting

Other trials in Canada

Taiwan3 sites, 3 recruiting

  • National Cheng Kung University Hospital

    Tainan, 00704

    Recruiting

  • Taipei Veterans General Hospital

    Taipei, 112201

    Recruiting

  • National Taiwan University Hospital

    Zhongzheng Dist., 10048

    Recruiting

Other trials in Taiwan

Denmark2 sites, 1 recruiting

  • Herlev Hospital, Afdeling for Kræftbehandling, Center for Kræftforskning, Klinisk Forskningsenhed

    Herlev, 2730

    Recruiting

  • Rigshospitalet, Onkologisk Klinik

    København Ø, 2100

    Completed

Other trials in Denmark

Australia1 site, 1 recruiting

  • Peter Maccallum Cancer Centre

    Melbourne, Victoria, 3000

    Recruiting

Other trials in Australia

About this study

Official title: 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.

Being tested
Inavolisib, Bevacizumab, Cetuximab, Atezolizumab, Tiragolumab
Keywords
KRAS G12C
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InavolisibDrug

    Inavolisib will be administered orally as per schedule specified in the respective arms.

  • BevacizumabDrug

    Also called Avastin

    Bevacizumab IV will be administered as per schedule specified in the respective arm.

  • CetuximabDrug

    Cetuximab IV will be administered as per schedule specified in the respective arm.

  • AtezolizumabDrug

    Also called Tecentriq

    Atezolizumab IV infusion will be administered as per schedule specified in the respective arm.

  • TiragolumabDrug

    Tiragolumab IV infusion will be administered as per schedule specified in the respective arm.

  • SY-5609Drug

    SY-5609 will be administered by mouth as per schedule specified in the respective arm.

  • DivarasibDrug

    Also called GDC-6036

    Divarasib will be administered orally as per schedule specified in the respective arms.

  • FOLFOXDrug

    FOLFOX (5-fluorouracil, leucovorin, oxaliplatin) IV will be administered as per schedule specified in the respective arm.

  • FOLFIRIDrug

    FOLFIRI (leucovorin, 5-fluorouracil, irinotecan) IV will be administered as per schedule specified in the respective arm.

  • FoundationOne®Liquid CDxDiagnostic test

    FoundationOne®Liquid CDx is used to identify presence of genomic alterations for participant cohort assignment.

Study groups in NCT04929223
Study groupRoleWhat they receive
Inavolisib + CetuximabExperimentalParticipants 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.
Receives: Drug: Inavolisib; Drug: Cetuximab; Diagnostic Test: FoundationOne®Liquid CDx
Inavolisib + BevacizumabExperimentalParticipants 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.
Receives: Drug: Inavolisib; Drug: Bevacizumab; Diagnostic Test: FoundationOne®Liquid CDx
Atezolizumab + Tiragolumab + BevacizumabExperimentalParticipants 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.
Receives: Drug: Bevacizumab; Drug: Atezolizumab; Drug: Tiragolumab; Diagnostic Test: FoundationOne®Liquid CDx
Atezolizumab + TiragolumabExperimentalParticipants 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.
Receives: Drug: Atezolizumab; Drug: Tiragolumab; Diagnostic Test: FoundationOne®Liquid CDx
Atezolizumab + SY-5609ExperimentalParticipants 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.
Receives: Drug: Atezolizumab; Drug: SY-5609; Diagnostic Test: FoundationOne®Liquid CDx
Divarasib + Cetuximab + FOLFOXExperimentalParticipants 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.
Receives: Drug: Cetuximab; Drug: Divarasib; Drug: FOLFOX; Diagnostic Test: FoundationOne®Liquid CDx
Divarasib + CetuximabExperimentalParticipants 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.
Receives: Drug: Cetuximab; Drug: Divarasib; Diagnostic Test: FoundationOne®Liquid CDx
Divarasib + Cetuximab + FOLFIRIExperimentalParticipants 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.
Receives: Drug: Cetuximab; Drug: Divarasib; Drug: FOLFIRI; Diagnostic Test: FoundationOne®Liquid CDx
Divarasib + Bevacizumab + FOLFOXExperimentalParticipants 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.
Receives: Drug: Bevacizumab; Drug: Divarasib; Drug: FOLFOX; Diagnostic Test: FoundationOne®Liquid CDx
Divarasib + Bevacizumab + FOLFIRIExperimentalParticipants 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.
Receives: Drug: Bevacizumab; Drug: Divarasib; Drug: FOLFIRI; Diagnostic Test: FoundationOne®Liquid CDx

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Approximately 84 months

Secondary outcomes (6)

  1. 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

    Measured: Approximately 84 months

  2. 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

    Measured: Approximately 84 months

  3. Percentage of Participants with Adverse Events (AEs)

    Percentage of participants with adverse events.

    Measured: Approximately 84 months

  4. 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.

    Measured: At pre-defined intervals from first administration of study drug up to approximately 84 months

  5. 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.

    Measured: Approximately 84 months

  6. 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.

    Measured: Approximately 84 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2021
  2. Study start22 Oct 2021
  3. Primary completion31 Aug 2030 (estimated)
  4. Study completion31 Aug 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
542 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04929223
Sponsor's protocol ID
WO42758
Other IDs
2021-001207-33, 2023-505163-37-00, 2023
Status last verified
Nov 2026
First submitted
11 Jun 2021
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Inavolisib, Bevacizumab and Cetuximab in people with Metastatic Colorectal Cancer, run by Hoffmann-La Roche at 84 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 84 sites in United States, Germany, United Kingdom, South Korea, Spain and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Reference Study ID Number: WO42758 https://forpatients.roche.com/ No attachments to email below. (888-662-6728 (U.S. and Canada), global-roche-genentech-trials@gene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (time frame: Approximately 84 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04929223.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.

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