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L'essai clinique NCT05581004 pour Tumeurs solides localement avancées ou métastatiques, CPNPC, HNSCC, Mélanome, TNBC, Cancer de l'œsophage, Cancer gastrique, Cancer du col de l'utérus, Cancer colo-rectal, Carcinome urothélial, Clear Cell RCC, CHC est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Vue en carte
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'essai' pour voir et discuter des informations sur l'essai dans la langue sélectionnée.
L'essai clinique NCT05581004 est conçu pour étudier le treatment de Tumeurs solides localement avancées ou métastatiques, CPNPC, HNSCC, Mélanome, TNBC, Cancer de l'œsophage, Cancer gastrique, Cancer du col de l'utérus, Cancer colo-rectal, Carcinome urothélial, Clear Cell RCC, CHC. Il s'agit d'un essai interventionnel en Phase I. Son statut actuel est : en recrutement. L'essai a débuté le 20 octobre 2022 et vise à recruter 450 participants. Dirigé par Genentech, Inc., l'essai devrait être terminé d'ici le 28 février 2027. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 5 novembre 2025.
Résumé succinct
This is a first-in-human study to evaluate the safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of RO7502175 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.
Titre officiel
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 Checkpoint Inhibitor in Patients With Locally Advanced or Metastatic Solid Tumors
Conditions
Tumeurs solides localement avancées ou métastatiquesCPNPCHNSCCMélanomeTNBCCancer de l'œsophageCancer gastriqueCancer du col de l'utérusCancer colo-rectalCarcinome urothélialClear Cell RCCCHCAutres identifiants de l'essai
- GO43860
- 2021-006708-34 (Numéro EudraCT)
Numéro NCT
Date de début (réel)
2022-10-20
Dernière mise à jour publiée
2025-11-05
Date de fin (estimée)
2027-02-28
Inscription (estimée)
450
Type d'essai
Interventionnel
PHASE
Phase I
Statut
En recrutement
Objectif principal
Traitement
Plan d'attribution
Non aléatoire
Modèle d'intervention
Séquentiel
Masquage
Aucun (ouvert)
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalPhase Ia: Dose Escalation Participants in successive cohorts will receive escalating doses of RO7502175, as an intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity. | RO7502175 RO7502175 will be administered as per the schedules specified in the respective arms. |
ExpérimentalPhase Ia: Expansion Participants with select solid tumors will receive a recommended dose of RO7502175, determined in Phase Ia Dose Escalation phase as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity. | RO7502175 RO7502175 will be administered as per the schedules specified in the respective arms. |
ExpérimentalPhase Ib: Dose Escalation Participants in successive cohorts will receive escalating doses of RO7502175, as an IV infusion, in combination with a fixed dose of atezolizumab, as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity. | RO7502175 RO7502175 will be administered as per the schedules specified in the respective arms. Atezolizumab Atezolizumab will be administered as per the schedules specified in the respective arms. |
ExpérimentalPhase Ib: Expansion Participants with select solid tumors will receive a recommended dose of RO7502175, determined in Phase Ib Dose Escalation phase, as an IV infusion, in combination with a fixed dose of atezolizumab or pembrolizumab, as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity. | RO7502175 RO7502175 will be administered as per the schedules specified in the respective arms. Atezolizumab Atezolizumab will be administered as per the schedules specified in the respective arms. Pembrolizumab Pembrolizumab will be administered as per the schedules specified in the respective arms. |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Phase Ia: Number of Participants with Dose Limiting Toxicities (DLTs) | From Day 1 to Day 21 of Cycle 1 (21 days from date of first dose of study treatment) | |
Phase Ib: Number of Participants with DLTs | From Day 1 to Day 21 of Cycle 1 (21 days from date of first dose of study treatment) | |
Phase Ia: Number of Participants with Treatment Emergent Adverse Events | Up to approximately 5 years | |
Phase Ib: Number of Participants with Treatment Emergent Adverse Events | Up to approximately 5 years |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Phase Ia and Phase Ib: Maximum Serum Concentration (Cmax) of RO7502175 | From Cycle 1 (each cycle is 21 days) Day1 and at multiple timepoints up to each follow-up visits (up to approximately 5 years) | |
Phase Ia and Phase Ib: Objective Response Rate (ORR) | From Cycle 1(each cycle is 21 days) Day 1, until disease progression, death, or end of study (up to approximately 5 years) | |
Phase Ia and Phase Ib: Duration of Response (DOR) | From Cycle 1 (each cycle is 21 days) Day 1, until disease progression, death, or end of study (up to approximately 5 years) | |
Phase Ia and Phase Ib: Progression Free Survival (PFS) | From Cycle 1 (each cycle is 21 days) Day 1, until disease progression, death, or end of study (up to approximately 5 years) | |
Phase Ia and Phase Ib: Percentage of Participants With Anti-Drug Antibody (ADA) to RO7502175 | From Cycle 1 (each cycle is 21 days) Day 1 and at multiple timepoints up to treatment discontinuation (up to approximately 5 years) |
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
- Life expectancy at least 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Measurable disease according to Response Evaluation criteria in Solid Tumors (RECIST) Version 1.1
- Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy
- Tumor Specimen availability
- Pregnant or breastfeeding or intention of becoming pregnant during the study or within 4 months after the final dose of RO7501275, or 4 months after the final dose of pembrolizumab, or 5 months after the final dose of atezolizumab
- Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to initiation of study treatment
- Active hepatitis B or C or tuberculosis
- Positive test for human immunodeficiency virus (HIV) infection
- Acute or chronic active Epstein-Barr virus (EBV) infection at screening
- Administration of a live, attenuated vaccine (e.g., FluMist) within 4 weeks before first RO7502175 infusion
- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
- Active or history of autoimmune disease
- Prior allogeneic stem cell or organ transplantation
Genentech, Inc.Contact central de l'essai
Contact: Reference Study ID Number: GO43860 https://forpatients.roche.com/, 888-662-6728 (U.S. Only), [email protected]
41 Centres de l'essai dans 10 pays
UZ Antwerpen, Edegem, 2650, Belgium
En recrutement
CHU de Liège, Herstal, 4040, Belgium
En recrutement
GasthuisZusters Antwerpen, Wilrijk, 2610, Belgium
En recrutement
British Columbia
British Columbia Cancer Agency, Vancouver, British Columbia, V5Z 4E6, Canada
En recrutement
Ontario
Ottawa Hospital Regional Cancer Centre, Ottawa, Ontario, K1H 8L6, Canada
En recrutement
Princess Margaret Cancer Centre, Toronto, Ontario, M5G 1Z5, Canada
En recrutement
Quebec
Sir Mortimer B Davis Jewish General Hospital, Montreal, Quebec, H3T 1E2, Canada
En recrutement
California
Stanford University, San Francisco, California, 94305, United States
En recrutement
Colorado
University Of Colorado, Aurora, Colorado, 80045, United States
En recrutement
Florida
Florida Cancer Specialists - Sarasota, Sarasota, Florida, 34232, United States
En recrutement
Georgia
Winship Cancer Institute, Atlanta, Georgia, 30322, United States
Terminé
Massachusetts
Dana Farber Cancer Institute, Boston, Massachusetts, 02215, United States
En recrutement
Michigan
Henry Ford Hospital, Detroit, Michigan, 48202, United States
En recrutement
Missouri
Washington University Medical Center, Division of Oncology, St Louis, Missouri, 63110, United States
Terminé
New Jersey
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, 08901, United States
En recrutement
Tennessee
The West Clinic - Memphis (Union Ave), Germantown, Tennessee, 38138, United States
En recrutement
SCRI Oncology Partners, Nashville, Tennessee, 37203, United States
En recrutement
Texas
South Texas Accelerated Research Therapeutics (START), San Antonio, Texas, 98229, United States
En recrutement
New South Wales
Kinghorn Cancer Centre, Darlinghurst, New South Wales, 2010, Australia
En recrutement
Victoria
Monash Health Monash Medical Centre, Clayton, Victoria, 3168, Australia
En recrutement
Western Australia
Linear Clinical Research Ltd, Nedlands, Western Australia, 6009, Australia
En recrutement
Attica
University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA, Chaïdári, Attica, 124 62, Greece
En recrutement
Sotiria Thoracic Diseases Hospital of Athens, Athens, 115 27, Greece
En recrutement
Papageorgiou General Hospital of Thessaloniki, Thessaloniki, 564 03, Greece
En recrutement
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis, Amsterdam, 1066 CX, Netherlands
En recrutement
Universitair Medisch Centrum Groningen, Groningen, 9713 GZ, Netherlands
En recrutement
Seoul National University Hospital, Seoul, 03080, South Korea
En recrutement
Asan Medical Center - PPDS, Seoul, 05505, South Korea
En recrutement
Samsung Medical Center - PPDS, Seoul, 06351, South Korea
En recrutement
Severance Hospital Yonsei University Health System - Clinical Trials Center Pharmacy, Seoul, 120-752, South Korea
En recrutement
Barcelona
ICO L'Hospitalet Hospital Duran I Reynals, L'Hospitalet de Llobregat, Barcelona, 08908, Spain
En recrutement
Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON, Barcelona, 08035, Spain
En recrutement
START MADRID_Hospital Universiario Fundacion Jimenez Diaz, Madrid, 28040, Spain
En recrutement
Hospital Universitario 12 De Octubre, Madrid, 28041, Spain
En recrutement
Hospital Universitario Virgen de la Victoria, Málaga, 29010, Spain
En recrutement
Hospital Clinico Universitario de Valencia, Valencia, 46010, Spain
En recrutement
Solna
Karolinska Universitetssjukhuset Solna, Stockholm, Solna, 17176, Sweden
En recrutement
Sahlgrenska Universitetssjukhuset, Gothenburg, 413 45, Sweden
En recrutement
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City, 807, Taiwan
En recrutement
Chung Shan Medical University Hospital, Taichung, 40201, Taiwan
En recrutement
National Taiwan University Hospital, Taipei, 10002, Taiwan
En recrutement