Trial Title:
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors
NCT ID:
NCT05581004
Condition:
Locally Advanced or Metastatic Solid Tumors
NSCLC
HNSCC
Melanoma
TNBC
Esophageal Cancer
Gastric Cancer
Cervical Cancer
Urothelial Carcinoma
Clear Cell RCC
HCC
Conditions: Official terms:
Atezolizumab
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
RO7502175
Description:
RO7502175 will be administered as per the schedules specified in the respective arms.
Arm group label:
Phase Ia: Dose Escalation
Arm group label:
Phase Ia: Expansion
Arm group label:
Phase Ib: Dose Escalation
Arm group label:
Phase Ib: Expansion
Intervention type:
Drug
Intervention name:
Atezolizumab
Description:
Atezolizumab will be administered as per the schedules specified in the respective arms.
Arm group label:
Phase Ib: Dose Escalation
Arm group label:
Phase Ib: Expansion
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 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, 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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, 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Stanford University'
Address:
City:
San Francisco
Zip:
94305
Country:
United States
Status:
Recruiting
Facility:
Name:
University Of Colorado
Address:
City:
Aurora
Zip:
80045
Country:
United States
Status:
Recruiting
Facility:
Name:
Florida Cancer Specialists - Sarasota
Address:
City:
Sarasota
Zip:
34232
Country:
United States
Status:
Recruiting
Facility:
Name:
Winship Cancer Institute
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Status:
Recruiting
Facility:
Name:
Dana Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Facility:
Name:
Henry Ford Hospital
Address:
City:
Detroit
Zip:
48202
Country:
United States
Status:
Recruiting
Facility:
Name:
Washington University Medical Center, Division of Oncology
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Completed
Facility:
Name:
Rutgers Cancer Institute of New Jersey
Address:
City:
New Brunswick
Zip:
08901
Country:
United States
Status:
Recruiting
Facility:
Name:
The West Clinic - Memphis (Union Ave)
Address:
City:
Germantown
Zip:
38138
Country:
United States
Status:
Recruiting
Facility:
Name:
SCRI Oncology Partners
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Facility:
Name:
South Texas Accelerated Research Therapeutics (START)
Address:
City:
San Antonio
Zip:
98229
Country:
United States
Status:
Recruiting
Facility:
Name:
Kinghorn Cancer Centre; St Vincents Hospital
Address:
City:
Darlinghurst
Zip:
2010
Country:
Australia
Status:
Recruiting
Facility:
Name:
Monash Health Monash Medical Centre
Address:
City:
Clayton
Zip:
3168
Country:
Australia
Status:
Recruiting
Facility:
Name:
Linear Clinical Research Ltd
Address:
City:
Nedlands
Zip:
6009
Country:
Australia
Status:
Recruiting
Facility:
Name:
UZ Antwerpen
Address:
City:
Edegem
Zip:
2650
Country:
Belgium
Status:
Recruiting
Facility:
Name:
CHU de Liège
Address:
City:
Liège
Zip:
4000
Country:
Belgium
Status:
Recruiting
Facility:
Name:
GasthuisZusters Antwerpen
Address:
City:
Wilrijk
Zip:
2610
Country:
Belgium
Status:
Recruiting
Facility:
Name:
British Columbia Cancer Agency
Address:
City:
Vancouver
Zip:
V5Z 4E6
Country:
Canada
Status:
Recruiting
Facility:
Name:
Ottawa Hospital Regional Cancer Centre
Address:
City:
Ottawa
Zip:
K1H 8M2
Country:
Canada
Status:
Recruiting
Facility:
Name:
Princess Margaret Cancer Centre
Address:
City:
Toronto
Zip:
M5G 1Z5
Country:
Canada
Status:
Recruiting
Facility:
Name:
Sir Mortimer B Davis Jewish General Hospital
Address:
City:
Montreal
Zip:
H3T 1E2
Country:
Canada
Status:
Recruiting
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Asan Medical Center - PPDS
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Samsung Medical Center - PPDS
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Severance Hospital Yonsei University Health System - Clinical Trials Center Pharmacy
Address:
City:
Seoul
Zip:
120-752
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
Address:
City:
Amsterdam
Zip:
1066 CX
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Universitair Medisch Centrum Groningen
Address:
City:
Groningen
Zip:
9713 GZ
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
ICO l?Hospitalet ? Hospital Duran i Reynals
Address:
City:
L?Hospitalet De Llobregat
Zip:
08908
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Vall d'Hebron - PPDS
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Facility:
Name:
START MADRID_Hospital Universiario Fundacion Jimenez Diaz
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario 12 De Octubre
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Virgen de la Victoria
Address:
City:
Malaga
Zip:
29010
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Clinico Universitario de Valencia
Address:
City:
Valencia
Zip:
46010
Country:
Spain
Status:
Recruiting
Start date:
October 20, 2022
Completion date:
August 31, 2026
Lead sponsor:
Agency:
Genentech, Inc.
Agency class:
Industry
Source:
Genentech, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05581004
