Clinical trial • Phase II • Gastroenterology

SOTORASIB for Colorectal cancer

Phase II trial of SOTORASIB for Colorectal cancer. open-label. 37 participants.

Overview

Trial Therapeutic Area
Gastroenterology
Trial Disease
Colorectal cancer
Trial Stage
Phase II
Drug Modality
Small molecule|Monoclonal antibody

Key dates

Initial CTIS Submission Date
19-11-2024
First CTIS Authorization Date
24-03-2025

Trial design

open-label Phase II trial in Italy, France, Germany and others.

Open Label
Yes
Target Sample Size
37

Eligibility

Recruits 37 Patients under judicial protection, legally institutionalized, under guardianship or not able to give consent are excluded. Participants must be able to understand and sign written informed consent (Age ≥ 18 years). Consent is provided directly by the adult participant; no provisions for assent are indicated. (isVulnerablePopulationSelected: false).

Pregnancy Exclusion
Pregnant or breastfeeding woman
Vulnerable Population
Patients under judicial protection, legally institutionalized, under guardianship or not able to give consent are excluded. Participants must be able to understand and sign written informed consent (Age ≥ 18 years). Consent is provided directly by the adult participant; no provisions for assent are indicated. (isVulnerablePopulationSelected: false)

Inclusion criteria

  • {"criterion_text":"- Age ≥ 18 years"}
  • {"criterion_text":"- Histologically proven advanced-stage unresectable locally advanced or metastatic colorectal adenocarcinoma"}
  • {"criterion_text":"- Agreement to participate to biological studies (blood samples for ctDNA and send tumour block)."}
  • {"criterion_text":"- Patient unfit for doublet/triplet regimen: Frail patients (WHO PS=2),patient between 70 and 75 years old with WHO PS 1 - 2, patient ≥ 75 years old with WHO PS 0-2"}
  • {"criterion_text":"- Proven KRAS G12C mutation as locally assessed by means of a IVDR compliant test."}
  • {"criterion_text":"- Measurable lesion according to the Response Evaluation Criteria in Solid Tumours 1.1 (RECIST 1.1)."}
  • {"criterion_text":"- No prior treatment for the metastatic disease. Prior adjuvant chemotherapy is allowed."}
  • {"criterion_text":"- Adequate organ function: Hemoglobin > 9 g/dl, Absolute neutrophil count > 1500 /mm3, Platelets > 80 000/mm3, Creatinine clearance rate ≥50 mL/min as calculated using MDRD formula, ALT/AST ≤5×ULN and total bilirubin ≤1.5×ULN."}
  • {"criterion_text":"- Ability to understand and sign written informed consent to participate in the study."}
  • {"criterion_text":"- Provides written informed consent for the study."}
  • {"criterion_text":"- Life expectancy >6 months"}
  • {"criterion_text":"- Women of childbearing potential must agree to use contraception during the trial treatment and for at least 6 months after discontinuation of the experimental treatments. Men who have sexual relationship with women of childbearing potential must agree to use contraception during treatment and for at least 3 months after discontinuation of the experimental treatments"}
  • {"criterion_text":"- Patient affiliated to a social security scheme for France, or equivalent for other countries"}

Exclusion criteria

  • {"criterion_text":"- Uncontrolled intercurrent illness including liver (liver cirrhosis Child Pugh B or C) and lung (one second forced expiratory volume <50%) severe insufficiency"}
  • {"criterion_text":"- Patient with interstitial lung disease or pulmonary fibrosis"}
  • {"criterion_text":"- Has a known psychiatric or substance abuse disorder that would interfere with the patient’s ability to cooperate with the requirements of the study"}
  • {"criterion_text":"- Patient who is under judicial protection and patient who is legally institutionalized or under guardianship or not able to give consent"}
  • {"criterion_text":"- Pregnant or breastfeeding woman"}
  • {"criterion_text":"- Inability to undergo the medical follow-up of the trial for geographical, social or psychological reasons"}
  • {"criterion_text":"- Clinically significant cardiac abnormalities including prior history of any of the following: severe cardiomyopathy, congestive heart failure of New York Heart Association grade ≥3, history of clinically significant (i.e., active) atherosclerotic cardiovascular disease (myocardial infarction, unstable angina, cerebrovascular accident within 6 months prior to the first dose of study treatments)"}
  • {"criterion_text":"- Patients with Dihydropyrimidine Dehydrogenase (DPD) enzyme deficiencies (uracilemia ≥ 16 ng/mL)"}
  • {"criterion_text":"- Immunotherapy within 3 months before the beginning of the treatment study"}
  • {"criterion_text":"- Patient under treatment by strong CYP3A4 inducers"}
  • {"criterion_text":"- Other malignancy within 2 years prior to study enrolment, except for localized cancer in situ, basal or squamous cell skin cancer adequately treated"}
  • {"criterion_text":"- Less than 4 weeks from major surgeries and not recovered adequately from the procedure and/or any complications from the surgery"}
  • {"criterion_text":"- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 3 weeks or 5 half-lives (whichever longer) before study entry"}
  • {"criterion_text":"- Hypersensitivity to one of the active substances or to one of the excipients of the trial treatments"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- The rate of patients alive without progression 8 months after the inclusion.","definition_or_measurement_approach":"Rate of patients alive without progression 8 months after inclusion; main objective measured based on investigator assessment using RECIST 1.1 (progression-free survival at 8 months)."}

Secondary endpoints

  • {"endpoint_text":"- PFS will be defined as the time between date of inclusion and the date of the first radiological progression using RECIST v1.1 criteria and according to the investigator assessment or death","definition_or_measurement_approach":"Progression-free survival (time from inclusion to first radiological progression per RECIST v1.1 by investigator assessment, or death)."}
  • {"endpoint_text":"- DCR will be defined at each time-point as complete (CR), partial (PR), stability (S), progression (P) or not evaluable with imageries and according to the investigator","definition_or_measurement_approach":"Disease control rate assessed at each time-point as CR, PR, stable disease, progression or not evaluable by imaging according to investigator."}
  • {"endpoint_text":"- ORR will be evaluated throughout the treatment by the imageries and according to RECIST v1.1 criteria.","definition_or_measurement_approach":"Objective response rate evaluated throughout treatment by imaging according to RECIST v1.1."}
  • {"endpoint_text":"- BOR will be evaluated throughout the treatment by the imageries and according to RECIST v1.1 criteria","definition_or_measurement_approach":"Best overall response assessed by imaging per RECIST v1.1 during treatment."}
  • {"endpoint_text":"- DoR is defined as the time between the first response of the patient and the date of radiological progression or death","definition_or_measurement_approach":"Duration of response: time from first documented response to radiological progression or death."}
  • {"endpoint_text":"- TTP will be defined as the time between the date of inclusion and the date of the first radiological progression. The death linked to the cancer’s evolution will also be considered as an event","definition_or_measurement_approach":"Time to progression: time from inclusion to first radiological progression; death related to cancer evolution considered an event."}
  • {"endpoint_text":"- OS is defined by the time between the date of inclusion and the date of death (regardless of the cause)","definition_or_measurement_approach":"Overall survival: time from inclusion to death from any cause."}
  • {"endpoint_text":"- Quality of life will be assessed with the EORTC QLQC30 questionnaire at each evaluation. The questionnaires are completed before the first treatment and during the study","definition_or_measurement_approach":"Quality of life measured using EORTC QLQ-C30 at baseline and at each evaluation during the study."}
  • {"endpoint_text":"- Geriatric assessments will be performed at baseline and during treatment using the G-CODE and G8-SCORE","definition_or_measurement_approach":"Geriatric assessment using G-CODE and G8-SCORE at baseline and during treatment."}
  • {"endpoint_text":"- Toxicity, according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be recorded until 30 days after the last administration of treatment","definition_or_measurement_approach":"Safety/toxicity recorded per NCI CTCAE v5.0 until 30 days after last treatment administration."}

Recruitment

Planned Sample Size
37
Recruitment Window Months
48
Consent Approach
Written informed consent is required from the participant (Adults only, age ≥18). Ability to understand and sign written informed consent is an inclusion criterion. Subject information and consent documents are provided (documents available in multiple languages and country-specific versions are included in the dossier, e.g., French, German, Spanish, Italian and redacted/TC versions). Consent covers study procedures and participation in biological studies (blood samples for ctDNA and tumor block shipment).

Geography

Total Number Of Sites
101
Total Number Of Participants
37

Italy

Earliest CTIS Part Ii Submission Date
14-01-2025
Latest Decision Or Authorization Date
07-01-2026
Processing Time Days
71
Number Of Sites
17
Number Of Participants
9

Sites

Site Name
Azienda Ospedaliero-Universitaria Di Cagliari
Department Name
Medical Oncology
Contact Person Name
Mario Scartozzi
Contact Person Email
marioscartozzi@unica.it
Site Name
Istituto Oncologico Veneto
Department Name
Oncology
Contact Person Name
Francesca Bergamo
Site Name
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Department Name
Medical Oncology
Contact Person Name
Vincenzo Formica
Contact Person Email
Vincenzo.formica@ptvonline.it
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
University Medical Oncology 2
Contact Person Name
Roberto Moretto
Contact Person Email
robertomoretto8468@gmail.com
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
Medical Oncology
Contact Person Name
Alessandro Passardi
Site Name
Azienda USL Toscana Centro
Department Name
Medical Oncology
Contact Person Name
Samantha Di Donato
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Medical Oncology
Contact Person Name
Filippo Pietrantonio
Site Name
Azienda Sanitaria Universitaria Friuli Centrale
Department Name
Oncology
Contact Person Name
Valentina Fanotto
Site Name
Azienda Unita' Sanitaria Locale Toscana Nord Ovest
Department Name
Oncology
Contact Person Name
Giacomo Allegrini
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Department of Medical and Surgical Sciences
Contact Person Name
Lisa Salvatore
Site Name
Casa Sollievo Della Sofferenza
Department Name
Oncology
Contact Person Name
Tiziana Pia Latiano
Contact Person Email
t.latiano@operapadrepio.it
Site Name
Careggi University Hospital
Department Name
Clinical Oncology
Contact Person Name
Lorenzo Antonuzzo
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
Medical Oncology 1U
Contact Person Name
Massimo Di Maio
Contact Person Email
massimo.dimaio@unito.it
Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
Oncology
Contact Person Name
Stefano Tamberi
Contact Person Email
stefano.tamberi@auslromagna.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Department Name
Medical Oncology
Contact Person Name
Giuseppe Novello
Contact Person Email
Giuseppe.novello@virgilio.it
Site Name
Pia Fondazione Di Culto E Religione Card G Panico
Department Name
Oncology
Contact Person Name
Emiliano Tamburini
Site Name
Centro Di Riferimento Oncologico Di Aviano
Department Name
Department of Medical Oncology and Oncological Prevention
Contact Person Name
Luisa Foltran
Contact Person Email
Luisa.foltran@cro.it

France

Earliest CTIS Part Ii Submission Date
14-02-2025
Latest Decision Or Authorization Date
13-01-2026
Processing Time Days
333
Number Of Sites
60
Number Of Participants
10

Sites

Site Name
Centre Hospitalier De Cholet
Department Name
Oncology
Contact Person Name
Thomas DAVIEAU
Contact Person Email
thomas.davieau@ch-cholet.fr
Site Name
GIE Groupe hospitalier Paris Saint-Joseph/Vinci
Department Name
oncology
Contact Person Name
Nabil BABA-HAMED
Contact Person Email
nbaba-hamed@ghpsj.fr
Site Name
Hospices Civils De Lyon
Department Name
Hepatogastroenterology
Contact Person Name
Camille MEUNIER
Contact Person Email
camille.meunier@chu-lyon.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Gastroenterology
Contact Person Name
Romain CHAUTARD
Contact Person Email
romain.chautard@univ-tours.fr
Site Name
Icone
Department Name
Oncology
Contact Person Name
William Mina
Contact Person Email
wmina@iccreims.fr
Site Name
Institut De Cancerologie De Bourgogne
Department Name
Gastroenterology
Contact Person Name
Antoine DROUILLARD
Site Name
Hopital Prive Sainte Marie Chalon
Department Name
oncology
Contact Person Name
Jean-Florian GUION
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Gastroenterology
Contact Person Name
Romain CORIAT
Contact Person Email
romain.coriat@aphp.fr
Site Name
Centre Hospitalier Universitaire De Caen Normandie
Department Name
Gastroenterology
Contact Person Name
Karine BOUHIER LEPORRIER
Contact Person Email
bouhierleporrier-k@chu-caen.fr
Site Name
Assistance Publique Hopitaux De Paris (20 Rue Leblanc)
Department Name
Hepatogastroenterology
Contact Person Name
Julien TAEIB
Contact Person Email
jtaeib75@gmail.com
Site Name
Centre Hospitalier Bethune Beuvry
Department Name
Gastroenterology
Contact Person Name
Hélène VAN DAMME
Contact Person Email
helene.vandamme@ch-bethune.fr
Site Name
Centre Hospitalier Annecy Genevois
Department Name
Gastroenterology
Contact Person Name
Emmanuel MAILLARD
Contact Person Email
emaillard@ch-annecygenevois.fr
Site Name
Hoptial La Timone
Department Name
Oncology
Contact Person Name
Leathicia DAHAN
Site Name
Pole Sante Leonard De Vinci
Department Name
Oncology
Contact Person Name
Pierre COMBE
Contact Person Email
p.combe@cort37.fr
Site Name
Hopital privé Le Bois
Department Name
Oncology
Contact Person Name
Côme DE METZ
Contact Person Email
shautecloque@clinique-psv.fr
Site Name
Centre Hospitalier Henri Mondor
Department Name
Hepatogastroenterology
Contact Person Name
Daniela BURLACU
Contact Person Email
d.burlacu@ch-aurillac.fr
Site Name
Centre Hospitalier De Colmar
Department Name
Gastroenterology
Contact Person Name
Rémi DARRIUS
Contact Person Email
remi.darrius@ch-colmar.fr
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Gastroenterology
Contact Person Name
David TOUGERON
Contact Person Email
david.tougeron@chu-poitiers.fr
Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
Oncology
Contact Person Name
Clémentine PEYRAMAURE
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Gastroenterology
Contact Person Name
Denis SMITH
Contact Person Email
denis.smith@chu-bordeaux.fr
Site Name
L'Hopital Prive Du Confluent
Department Name
oncology
Contact Person Name
Benjamin LINOT
Contact Person Email
blinot@vivalto-sante.com
Site Name
Centre Hospitalier General De St Denis
Department Name
Oncology
Contact Person Name
Gaëtan DES GUETZ
Contact Person Email
gaetan.desguetz@ch-stdenis.fr
Site Name
Hopital Europeen Marseille
Department Name
Gastroenterology
Contact Person Name
Nicolas BARRIERE
Contact Person Email
n.barriere@hopital-europeen.fr
Site Name
Centre Hospitalier Regional Universitaire (Besancon)
Department Name
Oncology
Contact Person Name
Angélique VIENOT
Contact Person Email
avienot@chu-besancon.fr
Site Name
Institut De Cancerologie De Lorraine
Department Name
oncology
Contact Person Name
Aurélien LAMBERT
Contact Person Email
a.lambert@nancy.unicancer.fr
Site Name
Union Mut Gestion Groupe Hosp Mutualiste De Grenoble
Department Name
Oncology
Contact Person Name
Hélène FLESCH
Contact Person Email
helene.flesch@avec.fr
Site Name
Centre Hospitalier Prive Saint-Gregoire
Department Name
Oncology
Contact Person Name
Edith CARTON
Contact Person Email
edith.carton@icrb.fr
Site Name
Hopital Prive Jean Mermoz
Department Name
Gastroenterology
Contact Person Name
Jérôme DESRAME
Contact Person Email
jerome.desrame@orange.fr
Site Name
Centre Hospitalier de Sens
Department Name
Oncology
Contact Person Name
Huu Thanh LE
Contact Person Email
HTLE@ch-sens.fr
Site Name
Institut De Cancerologie Strasbourg Europe
Department Name
Gastroenterology
Contact Person Name
Meher BEN ABDELGHANI
Contact Person Email
m.ben-abdelghani@icans.eu
Site Name
CH Villefranche Nord Ouest
Department Name
Gastroentérologue
Contact Person Name
Jonathan OLENSINKI
Contact Person Email
j.olensinski@HNO.fr
Site Name
Centre Hospitalier De La Cote Basque
Department Name
Gastroenterology
Contact Person Name
Franck AUDEMAR
Contact Person Email
faudemar@ch-cotebasque.fr
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Gastroenterology
Contact Person Name
Pierre Guillaume POUREAU
Site Name
Institut Godinot
Department Name
Oncology
Contact Person Name
Damien BOTSEN
Contact Person Email
dbotsen@chu-reims.fr
Site Name
Groupe Hospitalier Bretagne Sud
Department Name
Gastroenterology
Contact Person Name
Caroline COUFFON
Contact Person Email
c.couffon@ghbs.bzh

Germany

Earliest CTIS Part Ii Submission Date
24-02-2025
Latest Decision Or Authorization Date
07-01-2026
Processing Time Days
317
Number Of Sites
15
Number Of Participants
9

Sites

Site Name
ELBLANDKLINIKEN Stiftung & Co. KG
Department Name
Hämatologie/ Onkologie/Palliativemedizin
Contact Person Name
Jörg Schubert
Site Name
Kreiskliniken Reutlingen gGmbH
Department Name
Medizinische Klinik I
Contact Person Name
Angela Luise Huster
Contact Person Email
huster_A@klin-rt.de
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Clinic oh Internal Medicine II
Contact Person Name
Anne Letsch
Contact Person Email
Anne.Letsch@uksh.de
Site Name
Technische Universitaet Dresden
Department Name
Medizinische Klinik I
Contact Person Name
Gunnar Folprecht
Site Name
Katholisches Klinikum Bochum gGmbH
Department Name
Klinik für Hämatologie und Onkologie mit Palliativmedizin
Contact Person Name
Anke Reinacher-Schick
Contact Person Email
Anke.Reinacher@rub.de
Site Name
Leopoldina-Krankenhaus der Stadt Schweinfurt GmbH
Department Name
Medizinische Klinik II
Contact Person Name
Stephan Kanzler
Contact Person Email
skanzler@leopoldina.de
Site Name
Universitaetsmedizin Goettingen
Department Name
Klinik für Gastroenterologie, gastrointestinale Onkologie und Endokrinologie
Contact Person Name
Ute König
Site Name
Klinikum Suedstadt Rostock Eigenbetrieb der Hanse und Universitaetsstadt Rostock
Department Name
Klinik für Innere Medizin III
Contact Person Name
Beate Krammer-Steiner
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Medizinische Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunologie (CVK)
Contact Person Name
Dominik Modest
Contact Person Email
dominik.modest@charite.de
Site Name
Dr. Vehling-Kaiser MVZ GmbH
Department Name
ÜBAG MVZ Dr. Vehling-Kaiser GmbH
Contact Person Name
Florian Kaiser
Contact Person Email
dr.f.kaiser@vehling-kaiser.de
Site Name
Stiftung Mathias-Spital Rheine
Department Name
Mathias Spital Rheine
Contact Person Name
Sebastian Bröckling
Site Name
HELIOS Klinikum Bad Saarow GmbH
Department Name
Clinic for Oncology and Palliative Care
Contact Person Name
Daniel Pink
Site Name
Gemeinschaftspraxis Haematologie Onkologie
Department Name
Gemeinschaftspraxis Hämatologie-Onkologie Dresden
Contact Person Name
Lutz Jacobasch
Site Name
Krankenhaus Nordwest GmbH
Department Name
Institute of Clincial Cancer Research
Contact Person Name
Thorsten Götze
Contact Person Email
goetze.thorsten@khnw.de
Site Name
Hämatologisch-Onkologische Praxis Eppendorf (Hope)
Department Name
Norddeutsches Studienzentrum für Innovative Onkologie (NIO)
Contact Person Name
Alexander Stein
Contact Person Email
stein@hope-hamburg.de

Spain

Earliest CTIS Part Ii Submission Date
27-02-2025
Latest Decision Or Authorization Date
26-03-2026
Processing Time Days
392
Number Of Sites
9
Number Of Participants
9

Sites

Site Name
Institut Catala D'oncologia
Department Name
Oncology
Contact Person Name
Cristina Santos
Contact Person Email
csantos@iconcologia.net
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Contact Person Name
Clara Salvá
Contact Person Email
clarasalva@vhio.net
Site Name
Hospital General Universitario De Valencia
Department Name
Oncology
Contact Person Name
María José Safont
Contact Person Email
mjsafont@yahoo.es
Site Name
Hospital Universitario Central De Asturias
Department Name
Oncology
Contact Person Name
Paula Jiménez-Fonseca
Contact Person Email
palucaji@hotmail.com
Site Name
Hospital Universitario Reina Sofia
Department Name
Oncology
Contact Person Name
Gema Pulido
Contact Person Email
gemapulido.gp@gmail.com
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Oncology
Contact Person Name
Pilar García
Contact Person Email
pgarcaalfonso@gmail.com
Site Name
Hospital Universitario De Navarra
Department Name
Oncology
Contact Person Name
Ruth Vera
Contact Person Email
ruth.vera.garcia@navarra.es
Site Name
Hospital Universitario De Salamanca
Department Name
Oncology
Contact Person Name
Maria del Rosario Vidal
Contact Person Email
mrvidal@saludcastillayleon.es
Site Name
Hospital Clinico San Carlos
Department Name
Oncology
Contact Person Name
Javier Sastre
Contact Person Email
jsastrev@salud.madrid.org

Sponsor

Primary sponsor

Full Name
Fondation Franc.Cancerologie Digestive
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Investigational products

Investigational Product Name
SOTORASIB
Active Substance
SOTORASIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised
Maximum Dose
960 mg
Investigational Product Name
Vectibix 20 mg/ml concentrate for solution for infusion
Active Substance
PANITUMUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENIOUS INFUSION
Route
INTRAVENIOUS INFUSION
Authorisation Status
Authorised
Maximum Dose
6 mg/kg
Investigational Product Name
Fluorouracil (various authorised products)
Active Substance
FLUOROURACIL
Modality
Small molecule
Routes Of Administration
INTRAVENOUS / INFUSION
Route
INTRAVENOUS/INFUSION
Authorisation Status
Authorised
Maximum Dose
2400 mg/m2
Investigational Product Name
FOLINATE DE CALCIUM HIKMA 10 mg/mL, solution injectable/pour perfusion
Active Substance
FOLINIC ACID
Modality
Small molecule
Routes Of Administration
INTRAVENIOUS INFUSION
Route
INTRAVENIOUS INFUSION
Authorisation Status
Authorised
Maximum Dose
400 mg/m2
Combination Treatment
Yes

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