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
- Conditions
- Locally Advanced or Metastatic Solid TumorsNSCLCHNSCCMelanomaTNBCEsophageal CancerGastric CancerCervical CancerColorectal CancerUrothelial Carcinoma
- Interventions
- Registration Number
- NCT05581004
- Lead Sponsor
- Genentech, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 450
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Phase Ia: Dose Escalation RO7502175 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. Phase Ib: Dose Escalation Atezolizumab 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. Phase Ib: Expansion Pembrolizumab 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. Phase Ib: Expansion Atezolizumab 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. Phase Ia: Expansion RO7502175 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. Phase Ib: Expansion RO7502175 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. Phase Ib: Dose Escalation RO7502175 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.
- Primary Outcome Measures
Name Time Method 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 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)
- Secondary Outcome Measures
Name Time Method 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)
Trial Locations
- Locations (33)
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
🇳🇱Amsterdam, Netherlands
Universitair Medisch Centrum Groningen
🇳🇱Groningen, Netherlands
Florida Cancer Specialists - Sarasota
🇺🇸Sarasota, Florida, United States
ICO l?Hospitalet ? Hospital Duran i Reynals
🇪🇸L?Hospitalet De Llobregat, Barcelona, Spain
Winship Cancer Institute
🇺🇸Atlanta, Georgia, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Samsung Medical Center - PPDS
🇰🇷Seoul, Korea, Republic of
Severance Hospital Yonsei University Health System - Clinical Trials Center Pharmacy
🇰🇷Seoul, Korea, Republic of
Hospital Universitario Vall d'Hebron - PPDS
🇪🇸Barcelona, Spain
Hospital Clinico Universitario de Valencia
🇪🇸Valencia, Spain
START MADRID_Hospital Universiario Fundacion Jimenez Diaz
🇪🇸Madrid, Spain
Hospital Universitario 12 De Octubre
🇪🇸Madrid, Spain
Hospital Universitario Virgen de la Victoria
🇪🇸Malaga, Spain
Stanford University
🇺🇸San Francisco, California, United States
University Of Colorado
🇺🇸Aurora, Colorado, United States
Washington University Medical Center, Division of Oncology
🇺🇸Saint Louis, Missouri, United States
Rutgers Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
The West Clinic - Memphis (Union Ave)
🇺🇸Germantown, Tennessee, United States
SCRI Oncology Partners
🇺🇸Nashville, Tennessee, United States
South Texas Accelerated Research Therapeutics (START)
🇺🇸San Antonio, Texas, United States
Kinghorn Cancer Centre
🇦🇺Darlinghurst, New South Wales, Australia
Monash Health Monash Medical Centre
🇦🇺Clayton, Victoria, Australia
Linear Clinical Research Ltd
🇦🇺Nedlands, Western Australia, Australia
UZ Antwerpen
🇧🇪Edegem, Belgium
CHU de Liège
🇧🇪Herstal, Belgium
GasthuisZusters Antwerpen
🇧🇪Wilrijk, Belgium
British Columbia Cancer Agency
🇨🇦Vancouver, British Columbia, Canada
Ottawa Hospital Regional Cancer Centre
🇨🇦Ottawa, Ontario, Canada
Princess Margaret Cancer Centre
🇨🇦Toronto, Ontario, Canada
Sir Mortimer B Davis Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center - PPDS
🇰🇷Seoul, Korea, Republic of