Il s'agit d'une première étude chez l'homme pour évaluer la sécurité, la tolérabilité, la pharmacocinétique (PK) et l'activité anti-tumorale de RO7502175 lorsqu'il est administré en tant qu'agent unique et en combinaison avec atezolizumab ou pembrolizumab chez des participants adultes atteints de tumeurs solides localement avancées ou métastatiques, y compris le cancer du poumon non à petites cellules (NSCLC), le carcinome épidermoïde de la tête et du cou (HNSCC), le mélanome, le cancer du sein triple négatif (TNBC), le cancer de l'œsophage, le cancer gastrique, le cancer du col utérin, le cancer colorectal (CRC), le carcinome urothélial (UC), le carcinome à cellules rénales claires (RCC) et le carcinome hépatocellulaire (HCC). Les participants seront inscrits en 2 étapes : escalade de dose et expansion de dose.
Source : traduction non-officielle opérée par intelligence artificielle
voir le texte original
This is a first-in-human study to evaluate the safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of enzelkitug when administered as a single agent and in combination with atezolizumab or pembrolizumab in adult participants with locally advanced or metastatic solid tumors, including non small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), melanoma, triple-negative breast cancer (TNBC), esophageal cancer, gastric cancer, cervical cancer, colorectal cancer (CRC), urothelial carcinoma (UC), clear cell renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC). Participants will be enrolled in 2 stages: dose escalation and dose expansion.
RECRUTEMENT
Profil des participants
Sexe(s) des participants
Femmes
Hommes
Aptitude des participants
Majeurs aptes
Condition médicale (spécialité visée)
Choix aire thérapeutique
Cancérologie / Radio-oncologie/ tumeurs solides
Critères de sélection
Critères d'inclusion
• Signed Informed Consent Form
• Age ≥18 years at time of signing Informed Consent Form
• Ability to comply with the study protocol, in the investigator’s judgment
• ECOG Performance Status of 0 or 1
• Life expectancy ≥12 weeks
• Adequate hematologic and end-organ function, defined by the following laboratory and diagnostic test results, obtained within 14 days prior to initiation of study treatment:
• Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy
• Availability of representative tumor specimens in formalin-fixed, paraffin-embedded (FFPE) blocks (preferred) or ≥15 unstained slides, with an associated pathology report within 3 years of screening
• Measurable disease per RECIST v1.1
• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs,
• For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm
There are additional Inclusion Criteria for each cohorts of the study described in the study protocol.
Source : Importé depuis le centre
Critères d'exclusion
• Pregnant or breastfeeding, or intending to become pregnant during the study or within 5 months after the final dose of study treatment
• Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, and/or radiotherapy, within 3 weeks prior to initiation of study treatment,
• Treatment with cancer vaccines within 6 weeks or 5 drug elimination half-lives (whichever is shorter) prior to initiation of study treatment
• Systemic immunostimulatory agents (including, but not limited to, IFNs and IL-2) within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment and during study treatment
• Prior treatment with regulatory T-cell depleting agents including, but not limited to CD25-targeting agent (e.g., RO7296682, basiliximab), CC chemokine receptor 4 (e.g., mogamulizumab), CCR8-targeting agents (e.g., BMS-986340, GS-1811), with the exception of RO7502175 treatment during the Phase Ia portion of the study (i.e., for patients crossing over to the Phase Ib portion of the study)
• Symptomatic, untreated, or actively progressing CNS metastases
• History of leptomeningeal disease
• Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for ≥ 2 weeks prior to screening
• Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina
• Mean (average of triplicate measurements) QT interval corrected through use of Fridericia's formula (QTcF) >470 ms
• Any diseases, 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 patient at high risk from treatment complications
• Uncontrolled tumor-related pain
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
• Uncontrolled or symptomatic hypercalcemia (ionized calcium > 1.5 mmol/L, calcium >12 mg/dL, or corrected calcium > ULN)
• History of malignancy other than disease under study within 3 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate >90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer
• Adverse events from prior anti-cancer therapy (with the exception of immune-related adverse events attributed to cancer immunotherapy; see below) that have not resolved to Grade ≤1 except for alopecia, vitiligo, or endocrinopathy managed with replacement therapy
• Any history of an immune-mediated Grade 4 adverse event attributed to prior cancer immunotherapy (other than endocrinopathy managed with replacement therapy or asymptomatic elevation of serum lipase)
• Any history of an immune-mediated Grade 3 adverse event attributed to prior cancer immunotherapy (other than endocrinopathy managed with replacement therapy or asymptomatic elevation of serum lipase) that resulted in permanent discontinuation of the prior immunotherapeutic agent and/or occurred ≤6 months prior to planned Day 1 of Cycle 1
• Any immune-mediated adverse events related to prior cancer immunotherapy (other than endocrinopathy managed with replacement therapy or stable vitiligo) that have not resolved completely to baseline
• Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis,
• History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
• Active tuberculosis
• Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
• Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment
• Positive test for HIV infection
• Positive hepatitis B surface antigen (HbsAg) test, and/or positive total hepatitis B core antibody (HbcAb) test at screening.
• Positive hepatitis C virus (HCV) antibody test at screening
• Acute or chronic active EBV infection at screening
• Known infection with SARS-CoV-2 (the virus that causes COVID-19), persistent symptoms of known prior SARS-CoV-2 infection, and/or known positive COVID-19 test within 4 weeks prior to screening
• Administration of a live, attenuated vaccine (e.g., FluMist) within 4 weeks before first RO7502175 infusion or anticipation that such a live, attenuated vaccine will be required during the study or within 5 months after the final dose of study treatment
• Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti−TNF-α agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment,
There are additional Exclusion Criteria for each cohorts of the study described in the study protocol.
Source : Importé depuis le centre
Intervention
RO7502175, ATEZOLIZUMAB
Source : Importé depuis le centre
Cohortes
Donnée non disponible
Données à jour depuis :
14 mai 2026
SITES ET CONTACTS
Centre principal
Centre intégré universitaire de santé et de services sociaux du Centre-Ouest-de-l’Île-de-Montréal
Nous verifions auprès de chaque centre si des nouvelles informations sont disponibles
Identifiant
CR2220GE - GO43860
Titre
Une étude de phase ia/ib, ouverte, multicentrique, à escalade de dose pour évaluer la sécurité, la pharmacocinétique et l'activité de ro7502175 en tant qu'agent unique et en combinaison avec l'atezolizumab chez des patients atteints de tumeurs solides localement avancées ou métastatiques
Source : traduction non-officielle opérée par intelligence artificielle
voir le texte original
A PHASE Ia/Ib, OPEN LABEL, MULTICENTER, DOSE-ESCALATION STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND ACTIVITY OF RO7502175 AS A SINGLE AGENT AND IN COMBINATION WITH ATEZOLIZUMAB IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS
• Signed Informed Consent Form
• Age ≥18 years at time of signing Informed Consent Form
• Ability to comply with the study protocol, in the investigator’s judgment
• ECOG Performance Status of 0 or 1
• Life expectancy ≥12 weeks
• Adequate hematologic and end-organ function, defined by the following laboratory and diagnostic test results, obtained within 14 days prior to initiation of study treatment:
• Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy
• Availability of representative tumor specimens in formalin-fixed, paraffin-embedded (FFPE) blocks (preferred) or ≥15 unstained slides, with an associated pathology report within 3 years of screening
• Measurable disease per RECIST v1.1
• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs,
• For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm
There are additional Inclusion Criteria for each cohorts of the study described in the study protocol.
Source : Importé depuis le centre
Critères d'exclusion
• Pregnant or breastfeeding, or intending to become pregnant during the study or within 5 months after the final dose of study treatment
• Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, and/or radiotherapy, within 3 weeks prior to initiation of study treatment,
• Treatment with cancer vaccines within 6 weeks or 5 drug elimination half-lives (whichever is shorter) prior to initiation of study treatment
• Systemic immunostimulatory agents (including, but not limited to, IFNs and IL-2) within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment and during study treatment
• Prior treatment with regulatory T-cell depleting agents including, but not limited to CD25-targeting agent (e.g., RO7296682, basiliximab), CC chemokine receptor 4 (e.g., mogamulizumab), CCR8-targeting agents (e.g., BMS-986340, GS-1811), with the exception of RO7502175 treatment during the Phase Ia portion of the study (i.e., for patients crossing over to the Phase Ib portion of the study)
• Symptomatic, untreated, or actively progressing CNS metastases
• History of leptomeningeal disease
• Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for ≥ 2 weeks prior to screening
• Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina
• Mean (average of triplicate measurements) QT interval corrected through use of Fridericia's formula (QTcF) >470 ms
• Any diseases, 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 patient at high risk from treatment complications
• Uncontrolled tumor-related pain
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
• Uncontrolled or symptomatic hypercalcemia (ionized calcium > 1.5 mmol/L, calcium >12 mg/dL, or corrected calcium > ULN)
• History of malignancy other than disease under study within 3 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate >90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer
• Adverse events from prior anti-cancer therapy (with the exception of immune-related adverse events attributed to cancer immunotherapy; see below) that have not resolved to Grade ≤1 except for alopecia, vitiligo, or endocrinopathy managed with replacement therapy
• Any history of an immune-mediated Grade 4 adverse event attributed to prior cancer immunotherapy (other than endocrinopathy managed with replacement therapy or asymptomatic elevation of serum lipase)
• Any history of an immune-mediated Grade 3 adverse event attributed to prior cancer immunotherapy (other than endocrinopathy managed with replacement therapy or asymptomatic elevation of serum lipase) that resulted in permanent discontinuation of the prior immunotherapeutic agent and/or occurred ≤6 months prior to planned Day 1 of Cycle 1
• Any immune-mediated adverse events related to prior cancer immunotherapy (other than endocrinopathy managed with replacement therapy or stable vitiligo) that have not resolved completely to baseline
• Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis,
• History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
• Active tuberculosis
• Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
• Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment
• Positive test for HIV infection
• Positive hepatitis B surface antigen (HbsAg) test, and/or positive total hepatitis B core antibody (HbcAb) test at screening.
• Positive hepatitis C virus (HCV) antibody test at screening
• Acute or chronic active EBV infection at screening
• Known infection with SARS-CoV-2 (the virus that causes COVID-19), persistent symptoms of known prior SARS-CoV-2 infection, and/or known positive COVID-19 test within 4 weeks prior to screening
• Administration of a live, attenuated vaccine (e.g., FluMist) within 4 weeks before first RO7502175 infusion or anticipation that such a live, attenuated vaccine will be required during the study or within 5 months after the final dose of study treatment
• Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti−TNF-α agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment,
There are additional Exclusion Criteria for each cohorts of the study described in the study protocol.
Source : Importé depuis le centre
Cohortes
Thérapie ou Intervention proposée
Intervention
RO7502175, ATEZOLIZUMAB
Source : Importé depuis le centre
Cohortes
Donnée non disponible
Données à jour depuis :
14 mai 2026
Description de l'étude
Description de l'étude
Résumé de l'étude
Il s'agit d'une première étude chez l'homme pour évaluer la sécurité, la tolérabilité, la pharmacocinétique (PK) et l'activité anti-tumorale de RO7502175 lorsqu'il est administré en tant qu'agent unique et en combinaison avec atezolizumab ou pembrolizumab chez des participants adultes atteints de tumeurs solides localement avancées ou métastatiques, y compris le cancer du poumon non à petites cellules (NSCLC), le carcinome épidermoïde de la tête et du cou (HNSCC), le mélanome, le cancer du sein triple négatif (TNBC), le cancer de l'œsophage, le cancer gastrique, le cancer du col utérin, le cancer colorectal (CRC), le carcinome urothélial (UC), le carcinome à cellules rénales claires (RCC) et le carcinome hépatocellulaire (HCC). Les participants seront inscrits en 2 étapes : escalade de dose et expansion de dose.
Source : traduction non-officielle opérée par intelligence artificielle
voir le texte original
This is a first-in-human study to evaluate the safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of enzelkitug when administered as a single agent and in combination with atezolizumab or pembrolizumab in adult participants with locally advanced or metastatic solid tumors, including non small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), melanoma, triple-negative breast cancer (TNBC), esophageal cancer, gastric cancer, cervical cancer, colorectal cancer (CRC), urothelial carcinoma (UC), clear cell renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC). Participants will be enrolled in 2 stages: dose escalation and dose expansion.
Centres participants
Sites
Centres participants
1
centres
CENTRE INTÉGRÉ UNIVERSITAIRE DE SANTÉ ET DE SERVICES SOCIAUX DU CENTRE-OUEST-DE-L’ÎLE-DE-MONTRÉAL
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