Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT04929223

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

Led by Hoffmann-La Roche · Updated on 2026-04-27

542

Participants Needed

76

Research Sites

462 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed cohort-specific Informed Consent Form
  • Age 18 years or older at time of signing Informed Consent Form
  • Biomarker eligibility determined by validated local or blood-based tests
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Life expectancy of 3 months or more
  • Histologically confirmed adenocarcinoma of the colon or rectum
  • Metastatic disease present
  • Prior therapies for metastatic colorectal cancer
  • Ability to comply with the study protocol
  • Measurable disease with at least one target lesion per RECIST v1.1
  • Baseline tumor tissue samples available for biomarker research
  • Adequate blood and organ function within 14 days before starting study treatment
  • Women of childbearing potential agree to abstinence or use contraception
  • Men agree to abstinence or contraception and refrain from sperm donation
Not Eligible

You will not qualify if you...

  • Currently participating in another interventional clinical trial (follow-up period allowed)
  • Systemic anti-cancer treatment within 2 weeks or 5 half-lives before study treatment
  • Investigational therapy within 28 days before study treatment
  • Pregnant, breastfeeding, or planning pregnancy during the study
  • Serious medical condition or lab abnormality that prevents safe participation or data interpretation
  • Severe infection within 4 weeks before study treatment or active infection affecting safety
  • Incomplete recovery from surgery before study treatment
  • Uncontrolled pleural, pericardial effusion, or ascites needing frequent drainage
  • Uncontrolled tumor-related pain
  • Uncontrolled or symptomatic high calcium levels
  • Clinically significant active liver disease
  • Untreated or progressing brain metastases
  • History of leptomeningeal disease or carcinomatous meningitis
  • Other malignancies within 2 years except low-risk cancers
  • Any condition or toxicity contraindicating investigational drug use or increasing risk of complications

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 76 locations

1

UAB Comprehensive Cancer Center

Birmingham, Alabama, United States, 35233

Withdrawn

2

Mayo Clinic Arizona

Phoenix, Arizona, United States, 85259

Completed

3

City of Hope Comprehensive Cancer Center

Duarte, California, United States, 91010

Active, Not Recruiting

4

cCare

Encinitas, California, United States, 92024

Withdrawn

5

USC Norris Cancer Center

Los Angeles, California, United States, 90033

Completed

6

Cedars-Sinai Medical Center

Los Angeles, California, United States, 90048

Active, Not Recruiting

7

UCLA

Los Angeles, California, United States, 90095

Actively Recruiting

8

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States, 92663

Withdrawn

9

Stanford Cancer Center

Stanford, California, United States, 94305-5820

Completed

10

University of Colorado Cancer Center

Aurora, Colorado, United States, 80045

Active, Not Recruiting

11

Yale Cancer Center

New Haven, Connecticut, United States, 06520

Actively Recruiting

12

Eastern Ct Hema/Onco Assoc

Norwich, Connecticut, United States, 06360

Actively Recruiting

13

Mayo Clinic in Florida

Jacksonville, Florida, United States, 32224

Withdrawn

14

Moffitt Cancer Center

Tampa, Florida, United States, 33612

Active, Not Recruiting

15

Mary Bird Perkins Cancer Ctr

Baton Rouge, Louisiana, United States, 70809

Actively Recruiting

16

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114-2621

Completed

17

Karmanos Cancer Institute

Detroit, Michigan, United States, 48201

Withdrawn

18

Mayo Clinic Rochester

Rochester, Minnesota, United States, 55902

Actively Recruiting

19

New York Cancer & Blood Specialists - New Hyde Park

New Hyde Park, New York, United States, 11042-1116

Actively Recruiting

20

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

New York, New York, United States, 10028

Actively Recruiting

21

New York Cancer & Blood Specialists

Port Jefferson Station, New York, United States, 11776

Actively Recruiting

22

New York Cancer & Blood Specialists - Bronx

The Bronx, New York, United States, 10469-5930

Actively Recruiting

23

Duke University Medical Center

Durham, North Carolina, United States, 27710

Completed

24

Hematology Oncology Salem

Salem, Oregon, United States, 97301

Active, Not Recruiting

25

UPMC - Hillman Cancer Center

Pittsburgh, Pennsylvania, United States, 15232

Active, Not Recruiting

26

Sarah Cannon Research Institute / Tennessee Oncology

Nashville, Tennessee, United States, 37203

Completed

27

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

Completed

28

Lumi Research

Kingwood, Texas, United States, 77339

Withdrawn

29

Swedish Cancer Inst.

Seattle, Washington, United States, 98104

Completed

30

Medical Oncology Associates

Spokane, Washington, United States, 99208

Withdrawn

31

Peter Maccallum Cancer Centre

Melbourne, Victoria, Australia, 3000

Actively Recruiting

32

Princess Margaret Cancer Center

Toronto, Ontario, Canada, M5G 1X6

Active, Not Recruiting

33

Jewish General Hospital

Montreal, Quebec, Canada, H3T 1E2

Withdrawn

34

McGill University Health Center

Montreal, Quebec, Canada, H4A 3J1

Withdrawn

35

Rigshospitalet, Onkologisk Klinik

København Ø, Denmark, 2100

Actively Recruiting

36

Charité Universitätsmedizin Berlin

Berlin, Germany, 13353

Actively Recruiting

37

Katholisches Klinikum Bochum gGmbH - St. Josef-Hospital

Bochum, Germany, 44791

Actively Recruiting

38

Universitätsklinik Carl Gustav Carus der Technischen Universität Dresden

Dresden, Germany, 01307

Actively Recruiting

39

Universitätsklinikum Düsseldorf

Düsseldorf, Germany, 40225

Actively Recruiting

40

Asklepios Klinik Altona

Hamburg, Germany, 22763

Actively Recruiting

41

SLK-Kliniken Heilbronn GmbH;Klinik für Innere Medizin III

Heilbronn, Germany, 74078

Actively Recruiting

42

Klinikum der Universität München, Campus Großhadern

München, Germany, 81377

Withdrawn

43

Universitätsklinikum Ulm

Ulm, Germany, 89081

Actively Recruiting

44

Università degli Studi della Campania Luigi Vanvitelli

Naples, Campania, Italy, 80131

Actively Recruiting

45

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

Meldola, Emilia-Romagna, Italy, 47014

Actively Recruiting

46

Policlinico Universitario Agostino Gemelli IRCCS

Rome, Lazio, Italy, 00168

Actively Recruiting

47

Irccs Istituto Nazionale Dei Tumori (Int)

Milan, Lombardy, Italy, 20133

Actively Recruiting

48

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

Milan, Lombardy, Italy, 20162

Actively Recruiting

49

IRCCS Istituto Oncologico Veneto (IOV)

Padova, Veneto, Italy, 35128

Actively Recruiting

50

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

Gdansk, Poland, 80-952

Actively Recruiting

51

Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii

Krakow, Poland, 30-688

Suspended

52

Uniwersytecki Szpital Kliniczny w Poznaniu

Poznan, Poland, 60-569

Actively Recruiting

53

Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie

Warsaw, Poland, 02-781

Suspended

54

National Cancer Center

Goyang-si, South Korea, 10408

Actively Recruiting

55

Chonnam National University Hwasun Hospital

Jeollanam-do, South Korea, 58128

Actively Recruiting

56

Seoul National University Bundang Hospital

Seongnam-si, South Korea, 13605

Actively Recruiting

57

Samsung Medical Center

Seoul, South Korea, (0)6351

Actively Recruiting

58

Seoul National University Hospital

Seoul, South Korea, 03080

Actively Recruiting

59

Severance Hospital, Yonsei University Health System

Seoul, South Korea, 03722

Actively Recruiting

60

Asan Medical Center

Seoul, South Korea, 05505

Actively Recruiting

61

Hospital Universitario Puerta de Hierro - Majadahonda

Majadahonda, Madrid, Spain, 28222

Actively Recruiting

62

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

Barcelona, Spain, 08035

Actively Recruiting

63

START Madrid-FJD, Hospital Fundacion Jimenez Diaz

Madrid, Spain, 28040

Actively Recruiting

64

START Madrid. Centro Integral Oncologico Clara Campal

Madrid, Spain, 28050

Withdrawn

65

Hospital Clínico Universitario de Valencia

Valencia, Spain, 46010

Actively Recruiting

66

National Cheng Kung University Hospital

Tainan, Taiwan, 00704

Actively Recruiting

67

Taipei Veterans General Hospital

Taipei, Taiwan, 112201

Actively Recruiting

68

National Taiwan University Hospital

Zhongzheng Dist., Taiwan, 10048

Actively Recruiting

69

Addenbrookes Hospital

Cambridge, United Kingdom, CB2 0QQ

Actively Recruiting

70

Velindre Cancer Centre

Cardiff, United Kingdom, CF14 2TL

Actively Recruiting

71

Royal Free Hospital

London, United Kingdom, NW3 2QG

Withdrawn

72

Royal Marsden Hospital;Dept of Med-Onc

London, United Kingdom, SW3 6JJ

Actively Recruiting

73

Sarah Cannon Research Institute

London, United Kingdom, W1G 6AD

Actively Recruiting

74

Imperial College Healthcare NHS Trust

London, United Kingdom, W2 1NY

Actively Recruiting

75

The Christie NHS Foundation Trust

Manchester, United Kingdom, M20 4BX

Actively Recruiting

76

Royal Marsden Hospital

Sutton, United Kingdom, SM2 5PT

Actively Recruiting

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Research Team

R

Reference Study ID Number: WO42758 https://forpatients.roche.com/

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

10

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