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
Status: Recruiting
Location: See all (41) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
California
Stanford University
RECRUITING
San Francisco
Colorado
University Of Colorado
RECRUITING
Aurora
Florida
Florida Cancer Specialists - Sarasota
RECRUITING
Sarasota
Georgia
Winship Cancer Institute
COMPLETED
Atlanta
Massachusetts
Dana Farber Cancer Institute
RECRUITING
Boston
Michigan
Henry Ford Hospital
RECRUITING
Detroit
Missouri
Washington University Medical Center, Division of Oncology
COMPLETED
St Louis
New Jersey
Rutgers Cancer Institute of New Jersey
RECRUITING
New Brunswick
Tennessee
The West Clinic - Memphis (Union Ave)
RECRUITING
Germantown
SCRI Oncology Partners
RECRUITING
Nashville
Texas
South Texas Accelerated Research Therapeutics (START)
RECRUITING
San Antonio
Other Locations
Australia
Monash Health Monash Medical Centre
RECRUITING
Clayton
Kinghorn Cancer Centre
RECRUITING
Darlinghurst
Linear Clinical Research Ltd
RECRUITING
Nedlands
Belgium
UZ Antwerpen
RECRUITING
Edegem
CHU de Liège
RECRUITING
Herstal
GasthuisZusters Antwerpen
RECRUITING
Wilrijk
Canada
Sir Mortimer B Davis Jewish General Hospital
RECRUITING
Montreal
Ottawa Hospital Regional Cancer Centre
RECRUITING
Ottawa
Princess Margaret Cancer Centre
RECRUITING
Toronto
British Columbia Cancer Agency
RECRUITING
Vancouver
Greece
Sotiria Thoracic Diseases Hospital of Athens
RECRUITING
Athens
University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA
RECRUITING
Chaïdári
Papageorgiou General Hospital of Thessaloniki
RECRUITING
N. Efkapria-pavlos Melas
Netherlands
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
RECRUITING
Amsterdam
Universitair Medisch Centrum Groningen
RECRUITING
Groningen
Republic of Korea
Asan Medical Center - PPDS
RECRUITING
Seoul
Samsung Medical Center - PPDS
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital Yonsei University Health System - Clinical Trials Center Pharmacy
RECRUITING
Seoul
Spain
Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON
RECRUITING
Barcelona
ICO l?Hospitalet ? Hospital Duran i Reynals
RECRUITING
L'hospitalet De Llobregat
Hospital Universitario 12 De Octubre
RECRUITING
Madrid
START MADRID_Hospital Universiario Fundacion Jimenez Diaz
RECRUITING
Madrid
Hospital Universitario Virgen de la Victoria
RECRUITING
Málaga
Hospital Clinico Universitario de Valencia
RECRUITING
Valencia
Sweden
Sahlgrenska Universitetssjukhuset
RECRUITING
Gothenburg
Karolinska Universitetssjukhuset Solna
RECRUITING
Stokholm, Solna
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
RECRUITING
Kaohsiung City
Chung Shan Medical University Hospital
RECRUITING
Taichung
National Taiwan University Hospital
RECRUITING
Taipei
Contact Information
Primary
Reference Study ID Number: GO43860 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. Only)
Time Frame
Start Date: 2022-10-20
Estimated Completion Date: 2027-02-28
Participants
Target number of participants: 450
Treatments
Experimental: Phase 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.
Experimental: Phase 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.
Experimental: Phase 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.
Experimental: Phase 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.
Related Therapeutic Areas
Sponsors
Leads: Genentech, Inc.