Clinical trial • Phase II • Oncology
INAVOLISIB for Solid tumor
Phase II trial of INAVOLISIB for Solid tumor. 499 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Solid tumor
- Trial Stage
- Phase II
- Drug Modality
- Small molecule|Monoclonal antibody
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 10-06-2024
- First CTIS Authorization Date
- 12-07-2024
Trial design
Phase II trial in Italy, Germany, Portugal and others.
- Biomarker Stratified
- True, Somatic tumor genomic alterations (alteration/biomarker-positive cohorts; e.g. RET, NTRK, ALK, PIK3CA, KRAS G12C, BRAF, ROS1 as indicated by cohort-specific documents)
- Target Sample Size
- 499
Eligibility
Recruits 499 paediatric patients.
- Pregnancy Exclusion
- Pregnant or breastfeeding, or intending to become pregnant during the study
- Vulnerable Population
- Vulnerable populations are included (pediatric participants). Age-specific performance criteria and multiple paediatric age cohorts are specified (participants aged <16 years, 16 to <18 years, etc.). Assent and parental consent procedures are provided: multiple assent and parent/guardian ICF documents are listed for cohorts (e.g. Assent 3-11 yr, 7-11 yr, 12-17 yr and corresponding parent ICFs), indicating minors require parental consent and age-appropriate assent forms.
Inclusion criteria
- {"criterion_text":"- Histologically or cytologically confirmed diagnosis of advanced and unresectable or metastatic solid malignancy"}
- {"criterion_text":"- 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)"}
- {"criterion_text":"- Performance status as follows: Participants aged ≥ 18 years: Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2; Participants aged 16 to < 18 years: Karnofsky score ≥ 50%; Participants aged < 16 years: Lansky score ≥ 50%"}
- {"criterion_text":"- For participants aged ≥ 18 and <18 years: adequate hematologic and end-organ function"}
- {"criterion_text":"- Disease progression on prior treatment, or previously untreated disease with no available acceptable treatment"}
- {"criterion_text":"- Adequate recovery from most recent systemic or local treatment for cancer"}
Exclusion criteria
- {"criterion_text":"- Current participation or enrollment in another therapeutic clinical trial"}
- {"criterion_text":"- Any anticancer treatment within 2 weeks prior to start of study treatment (Please refer to the cohort-specific eligibility criteria for requirements on enrollment, if applicable)"}
- {"criterion_text":"- Whole brain radiotherapy within 14 days prior to start of study treatment"}
- {"criterion_text":"- Stereotactic radiosurgery within 7 days prior to start of study treatment"}
- {"criterion_text":"- Pregnant or breastfeeding, or intending to become pregnant during the study"}
- {"criterion_text":"- 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"}
Endpoints
Primary endpoints
- {"endpoint_text":"- 1 Independent Review Committee (IRC)-assessed objective response rate (ORR) based on confirmed (≥4 weeks after initial documentation of response) objective response (per RECIST v1.1)","definition_or_measurement_approach":"IRC-assessed ORR based on confirmed objective response (confirmation ≥4 weeks after initial documentation of response), evaluated per RECIST v1.1"}
Secondary endpoints
- {"endpoint_text":"- 1 IRC-assessed duration of response (DOR), clinical benefit rate (CBR), and progression-free survival (PFS) per RECIST v1.1","definition_or_measurement_approach":"Evaluated by IRC per RECIST v1.1"}
- {"endpoint_text":"- 2 Investigator (INV)-assessed ORR, DOR, CBR, and PFS per RECIST v1.1","definition_or_measurement_approach":"Assessed by investigator per RECIST v1.1"}
- {"endpoint_text":"- 3 IRC- and INV-assessed time to CNS progression per RECIST v1.1","definition_or_measurement_approach":"Time to CNS progression measured per RECIST v1.1 by IRC and investigator"}
- {"endpoint_text":"- 4 Overall survival (OS)","definition_or_measurement_approach":"Overall survival measured as time from baseline to death from any cause"}
- {"endpoint_text":"- 5 Cohorts A, B, C, D, I, J, and K: IRC-assessed CNS-ORR, CNS-DOR, CNS-CBR, and CNS-PFS per RANO","definition_or_measurement_approach":"IRC assessment per RANO criteria for CNS endpoints"}
- {"endpoint_text":"- 6 Cohorts A, B, C, D, I, J, and K: INV-assessed CNS-ORR, CNS-DOR, CNS-CBR, and CNS-PFS per RANO","definition_or_measurement_approach":"Investigator assessment per RANO criteria for CNS endpoints"}
- {"endpoint_text":"- 7 Cohorts A, B, C, D, E, H, I, J, K, L, M, and N: IRC-assessed ORR, DOR, CBR, and PFS per International Neuroblastoma Response Criteria (INRC)","definition_or_measurement_approach":"IRC assessment per INRC for neuroblastoma cohorts"}
- {"endpoint_text":"- 8 Cohorts A, B, C, D, E, H, I, J, K, L, M, and N: INV-assessed ORR, DOR, CBR, and PFS per INRC","definition_or_measurement_approach":"Investigator assessment per INRC for neuroblastoma cohorts"}
- {"endpoint_text":"- 9 Cohorts A, B, C, D, I, J, and K: IRC-assessed IC-ORR, IC-DOR, IC-CBR, IC-PFS rate per RECIST v1.1","definition_or_measurement_approach":"IRC assessment of intracranial (IC) endpoints per RECIST v1.1"}
- {"endpoint_text":"- 10. Cohorts A, B, C, D, I, J, and K: INV-assessed IC-ORR, IC-DOR, IC-CBR, IC-PFS per RECIST v1.1","definition_or_measurement_approach":"Investigator assessment of intracranial endpoints per RECIST v1.1"}
- {"endpoint_text":"- 11. Descriptive endpoint of time to confirmed deterioration, change from baseline, proportion of patients with a clinical meaningful change on the Global Health Status, Physical Functioning, and Role Functioning scores from the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30","definition_or_measurement_approach":"Patient-reported outcomes measured using EORTC QLQ-C30 (Global Health Status, Physical Functioning, Role Functioning); time to confirmed deterioration and proportion with clinically meaningful change"}
- {"endpoint_text":"- 12. Descriptive endpoint of time to confirmed symptom onset or worsening from tumor-related symptom scores from the EORTC QLQ-C30 and EORTC IL71","definition_or_measurement_approach":"Symptom scores from EORTC QLQ-C30 and EORTC IL71; time to confirmed symptom onset or worsening"}
- {"endpoint_text":"- 13. Incidence, type, and severity of adverse events (based on the NCI CTCAE v5.0), including serious adverse events","definition_or_measurement_approach":"Adverse events graded per NCI CTCAE v5.0; incidence, type and severity summarized"}
- {"endpoint_text":"- 14. Cohort K: for pediatric patients - evaluate the acceptability and palatability of pralsetinib with Acceptability Survey scores on Day 1 of Cycle 1","definition_or_measurement_approach":"Acceptability Survey scores on Day 1 of Cycle 1 for pralsetinib in pediatric cohort K"}
Recruitment
- Digital Remote Recruitment
- True, remote NGS prescreening documents are listed (e.g. "L1_SIS and ICF 7-11 yr NGS remote prescreening", "L1_SIS and ICF 12-17 yr NGS remote prescreening"), indicating remote/digital prescreening methods
- Planned Sample Size
- 499
- Recruitment Window Months
- 137
- Consent Approach
- Age-appropriate informed consent and assent processes are provided. Parental/guardian informed consent is required for minors; assent forms are provided for paediatric age groups (documents listed for 3-11 yr, 7-11 yr, 12-17 yr cohorts and corresponding parent ICFs). Separate ICFs and parent documents for paediatric and adult cohorts and remote prescreening ICFs are included.
Geography
- Total Number Of Sites
- 37
- Total Number Of Participants
- 407
Italy
- Earliest CTIS Part Ii Submission Date
- 26-06-2024
- Latest Decision Or Authorization Date
- 30-10-2025
- Processing Time Days
- 491
- Number Of Sites
- 7
- Number Of Participants
- 100
Sites
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- S.C. MEDICINA ONCOLOGICA 1
- Contact Person Name
- Silvia Damian
- Contact Person Email
- silvia.damian@istitutotumori.mi.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- UOS Fase I
- Contact Person Name
- Gennaro Daniele
- Contact Person Email
- gennaro.daniele@policlinicogemelli.it
- Site Name
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
- Department Name
- Osp. Infantile Regina Margherita
- Contact Person Name
- Franca Fagioli
- Contact Person Email
- franca.fagioli@unito.it
- Site Name
- Bambino Gesu Childrens Hospital
- Department Name
- Dipartimento di Onco-Ematologia Pediatrica
- Contact Person Name
- Franco Locatelli
- Contact Person Email
- franco.locatelli@opbg.net
- Site Name
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
- Department Name
- U.O. Oncologia Medica
- Contact Person Name
- Salvatore Grisanti
- Contact Person Email
- grisanti.salvatore@gmail.com
- Site Name
- Azienda Ospedaliera Universitaria Senese
- Department Name
- U.O.C. Immunoterapia Oncologica
- Contact Person Name
- Michele Maio
- Contact Person Email
- mmaiocro@gmail.com
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- S.C. Oncologia Pediatrica
- Contact Person Name
- Michela Casanova
- Contact Person Email
- michela.casanova@istitutotumori.mi.it
Germany
- Earliest CTIS Part Ii Submission Date
- 26-06-2024
- Latest Decision Or Authorization Date
- 30-10-2025
- Processing Time Days
- 491
- Number Of Sites
- 2
- Number Of Participants
- 7
Sites
- Site Name
- SLK-Kliniken Heilbronn GmbH
- Department Name
- Klinik für Innere Medizin III
- Contact Person Name
- Uwe Martens
- Contact Person Email
- medklinik3@slk-kliniken.de
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Westdeutsches Tumorzentrum
- Contact Person Name
- Martin Schuler
- Contact Person Email
- Martin.Schuler@uk-essen.de
Portugal
- Earliest CTIS Part Ii Submission Date
- 26-06-2024
- Latest Decision Or Authorization Date
- 29-10-2025
- Processing Time Days
- 490
- Number Of Sites
- 1
- Number Of Participants
- 13
Sites
- Site Name
- Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
- Department Name
- Serviço de Oncologia Médica
- Contact Person Name
- Júlio Oliveira
- Contact Person Email
- clinicalstudies@ipoporto.min-saude.pt
Belgium
- Earliest CTIS Part Ii Submission Date
- 26-06-2024
- Latest Decision Or Authorization Date
- 30-10-2025
- Processing Time Days
- 491
- Number Of Sites
- 5
- Number Of Participants
- 50
Sites
- Site Name
- UZ GENT
- Department Name
- Pediatric Hematology - Oncology
- Contact Person Name
- Bram De Wilde
- Contact Person Email
- Bram.DeWilde@uzgent.be
- Site Name
- Cliniques Universitaires Saint-Luc
- Department Name
- Medical oncology
- Contact Person Name
- Cedric Van Marcke
- Contact Person Email
- cedric.vanmarcke@saintluc.uclouvain.be
- Site Name
- Grand Hôpital de Charleroi - Site Les Viviers
- Department Name
- Oncology & Hematology
- Contact Person Name
- Jean-Luc Canon
- Contact Person Email
- jean-luc.canon@ghdc.be
- Site Name
- Antwerp University Hospital
- Department Name
- Multidisciplinary Oncology Centre
- Contact Person Name
- Hans Prenen
- Contact Person Email
- hans.prenen@uza.be
- Site Name
- UZ Leuven
- Department Name
- Oncology
- Contact Person Name
- Sabine Tejpar
- Contact Person Email
- sabine.tejpar@uzleuven.be
Denmark
- Earliest CTIS Part Ii Submission Date
- 26-06-2024
- Latest Decision Or Authorization Date
- 28-10-2025
- Processing Time Days
- 489
- Number Of Sites
- 1
- Number Of Participants
- 8
Sites
- Site Name
- Rigshospitalet
- Department Name
- Onkologisk Klinik
- Contact Person Name
- Kristoffer Rohrberg
- Contact Person Email
- kristoffer.staal.rohrberg@regionh.dk
Poland
- Earliest CTIS Part Ii Submission Date
- 26-06-2024
- Latest Decision Or Authorization Date
- 09-12-2025
- Processing Time Days
- 531
- Number Of Sites
- 4
- Number Of Participants
- 60
Sites
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Department Name
- Klinika Nowotworów Płuca i Klatki Piersiowej, Klinika Gin Onkologicznej, Oddział Badań Wczesnych Faz
- Contact Person Name
- Maciej Krzakowski
- Contact Person Email
- malgorzata.falgowska@nio.gov.pl
- Site Name
- Uniwersyteckie Centrum Kliniczne (Gdansk)
- Department Name
- Klinika Onkoligii i Radioterapii
- Contact Person Name
- Rafał Dziadziuszko
- Contact Person Email
- onkol@gumed.edu.pl
- Site Name
- Uniwersyteckie Centrum Kliniczne (Gdansk) - pediatrics
- Department Name
- Klinika Pediatrii, Hematologii i Onkologii
- Contact Person Name
- Rafał Dziadziuszko
- Contact Person Email
- onkol@gumed.edu.pl
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy (Warsaw)
- Department Name
- Klinika Onkologii i Radioterapii
- Contact Person Name
- Maciej Krzakowski
- Contact Person Email
- malgorzata.falgowska@nio.gov.pl
Spain
- Earliest CTIS Part Ii Submission Date
- 26-06-2024
- Latest Decision Or Authorization Date
- 31-10-2025
- Processing Time Days
- 492
- Number Of Sites
- 11
- Number Of Participants
- 95
Sites
- Site Name
- Hospital Infantil Universitario Nino Jesus
- Department Name
- Oncología
- Contact Person Name
- Alba Rubio San Simón
- Contact Person Email
- Alba.rubio@salud.madrid.org
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- Oncología
- Contact Person Name
- Irene Moreno Candilejo
- Contact Person Email
- irene.moreno@startmadrid.com
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Oncología
- Contact Person Name
- Javier Caballero Daroqui
- Contact Person Email
- daroqui@gmail.com
- Site Name
- Clinica Universidad De Navarra (Pamplona)
- Department Name
- Oncología
- Contact Person Name
- María Luisa Sánchez Lorenzo
- Contact Person Email
- lsanchezl@unav.es
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Oncología
- Contact Person Name
- Victor Moreno García
- Contact Person Email
- victor.moreno@startmadrid.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncología
- Contact Person Name
- Lucas Moreno Martín
- Contact Person Email
- lucas.moreno@vallhebron.cat
- Site Name
- Clinica Universidad De Navarra (Madrid)
- Department Name
- Oncología
- Contact Person Name
- María Luisa Sánchez Lorenzo
- Contact Person Email
- lsanchezl@unav.es
- Site Name
- Sant Joan De Deu Barcelona Hospital
- Department Name
- Oncología
- Contact Person Name
- Jaume Mora Graupera
- Contact Person Email
- jaume.mora@sjd.es
- Site Name
- Fir Huvh Fundacio Institut De Recerca Hospital Universitari Vall De Hebron
- Department Name
- Oncología
- Contact Person Name
- Elena Garralda Cábanas
- Contact Person Email
- egarralda@vhio.net
- Site Name
- Hospital Universitario La Paz
- Department Name
- Oncología
- Contact Person Name
- Javier De Castro Carpeno
- Contact Person Email
- javier.decastro@salud.madrid.org
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Oncología
- Contact Person Name
- Luis Paz- Arez Rodriguez
- Contact Person Email
- lpazaresr@seom.org
France
- Earliest CTIS Part Ii Submission Date
- 26-06-2024
- Latest Decision Or Authorization Date
- 02-02-2026
- Processing Time Days
- 586
- Number Of Sites
- 6
- Number Of Participants
- 74
Sites
- Site Name
- Institut Bergonie
- Department Name
- Medical Oncology
- Contact Person Name
- Veronique DEBIEN
- Contact Person Email
- v.debien@bordeaux.unicancer.fr
- Site Name
- Centre Oscar Lambret
- Department Name
- Oncology
- Contact Person Name
- Sandra RAIMBAULT
- Contact Person Email
- s-raimbault@o-lambret.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- Drug Development Department (DITEP) – U981 INSERM
- Contact Person Name
- Christophe MASSARD
- Contact Person Email
- christophe.massard@gustaveroussy.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Pediatric Immunology, Hematology and Oncology Department
- Contact Person Name
- Nicolas Andre
- Contact Person Email
- nicolas.andre@ap-hm.fr
- Site Name
- Institut Universitaire Du Cancer Toulouse-Oncopole
- Department Name
- Medical Oncology
- Contact Person Name
- Carlos Alberto Gomez Roca
- Contact Person Email
- gomezroca.carlos@iuct-oncopole.fr
- Site Name
- Centre Leon Berard
- Department Name
- Pediatric oncology
- Contact Person Name
- Nadege CORRADINI
- Contact Person Email
- nadege.corradini@ihope.fr
Sponsor
Primary sponsor
- Full Name
- F. Hoffmann-La Roche AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- IQVIA Limited
- Responsibilities
- sponsorDuties codes: [1]; contact eu_clinical_trials_information@iqvia.com
- Name
- Icon Development Solutions LLC
- Responsibilities
- sponsorDuties codes: [4]; sample management support (contact SampleManagementWhitesboro@iconplc.com)
Third parties
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes: [1]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Early Development Laboratories Inc.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"sponsorDuties codes: [3]","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"Median Technologies","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Caris Mpi Inc.","duties_or_roles":"Patient Recruitment/Retention Service Provider (sponsorDuties code 15)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Icon Development Solutions LLC","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Foundation Medicine Inc.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient Recruitment/Retention Service Provider (sponsorDuties code 15)","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Germany","full_name":"Foundation Medicine GmbH","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Ventana Medical Systems Inc.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Laboratory/Research/Testing facility"}
Investigational products
- Investigational Product Name
- INAVOLISIB
- Active Substance
- INAVOLISIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Maximum Dose
- 9 mg
- Investigational Product Name
- RO 743-5846/F04
- Active Substance
- DIVARASIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Investigational Product Name
- RO7223619
- Active Substance
- BELVARAFENIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Maximum Dose
- 800 mg
- Investigational Product Name
- Ipatasertib
- Active Substance
- IPATASERTIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Maximum Dose
- 400 mg
- Investigational Product Name
- Rozlytrek 200 mg hard capsules
- Active Substance
- ENTRECTINIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Marketing authorisation (EU) (EU/1/20/1460/002)
- Maximum Dose
- 600 mg
- Investigational Product Name
- Alecensa 150 mg hard capsules
- Active Substance
- ALECTINIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Marketing authorisation (IS) (EU/1/16/1169/001)
- Maximum Dose
- 1200 mg
- Investigational Product Name
- Rozlytrek 100 mg hard capsules
- Active Substance
- ENTRECTINIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Marketing authorisation (EU) (EU/1/20/1460/001)
- Maximum Dose
- 600 mg
- Investigational Product Name
- Tecentriq 1 200 mg concentrate for solution for infusion
- Active Substance
- ATEZOLIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- IV INFUSION
- Route
- IV INFUSION
- Authorisation Status
- Marketing authorisation (EU) (EU/1/17/1220/001)
- Maximum Dose
- 1200 mg
- Investigational Product Name
- Camonsertib
- Active Substance
- CAMONSERTIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Investigational Product Name
- RO 749-9790/F02-02
- Active Substance
- PRALSETINIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Maximum Dose
- 400 mg
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