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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
450
RO7502175 will be administered as per the schedules specified in the respective arms.
Atezolizumab will be administered as per the schedules specified in the respective arms.
Pembrolizumab will be administered as per the schedules specified in the respective arms.
Stanford University
San Francisco, California, United States
RECRUITINGUniversity Of Colorado
Aurora, Colorado, United States
RECRUITINGFlorida Cancer Specialists - Sarasota
Sarasota, Florida, United States
RECRUITINGWinship Cancer Institute
Atlanta, Georgia, United States
Phase Ia: Number of Participants with Dose Limiting Toxicities (DLTs)
Time frame: 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
Time frame: 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
Time frame: Up to approximately 5 years
Phase Ib: Number of Participants with Treatment Emergent Adverse Events
Time frame: Up to approximately 5 years
Phase Ia and Phase Ib: Maximum Serum Concentration (Cmax) of RO7502175
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: From Cycle 1 (each cycle is 21 days) Day 1 and at multiple timepoints up to treatment discontinuation (up to approximately 5 years)
Reference Study ID Number: GO43860 https://forpatients.roche.com/
CONTACT
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Dana Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGHenry Ford Hospital
Detroit, Michigan, United States
RECRUITINGWashington University Medical Center, Division of Oncology
St Louis, Missouri, United States
COMPLETEDRutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
RECRUITINGThe West Clinic - Memphis (Union Ave)
Germantown, Tennessee, United States
RECRUITINGSCRI Oncology Partners
Nashville, Tennessee, United States
RECRUITING...and 31 more locations