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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
- Cancer
- Head and Neck Cancer
- Squamous Cell Carcinoma
- Squamous Cell Carcinoma of the Head and Neck (SCCHN)
- Solid Tumors
- Advanced Solid Tumors
- Esophageal Cancer
- Hepatocellular Carcinoma (HCC)
- Lung Cancer
- Non-Small Cell Lung Cancer (NSCLC)
- Breast Cancer
- Triple Negative Breast Cancer
- Gastric Cancer
- Metastatic Solid Tumors
- Renal Cell Cancer (RCC)
- Clear Cell Renal Cell Carcinoma
- Melanoma
- Cervical Cancer
- Bladder Cancer
- Urothelial Carcinoma
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:
Recruiting
This trial runs in
Cities
- Amsterdam
- Antwerpen
- Atlanta
- Aurora
- Barcelona
- Boston
- Clayton
- Darlinghurst
- Detroit
- Edegem
- Groningen
- L'Hospitalet de Llobregat
- luik
- Madrid
- Memphis
- Montréal
- Málaga
- Nashville
- Nedlands
- New Brunswick
- Ottawa
- San Antonio
- San Francisco
- Sarasota
- Seoul
- St. Louis
- Toronto
- València
- Vancouver
Trial Identifier:
NCT05581004 2021-006708-34 GO43860
Trial 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.
Genentech, Inc.
Sponsor
Phase 1
Phase
NCT05581004, GO43860, 2021-006708-34
Trial Identifier
RO7502175, Atezolizumab
Treatments
Locally Advanced or Metastatic Solid Tumors, NSCLC, HNSCC, Melanoma, TNBC, Esophageal Cancer, Gastric Cancer, Cervical Cancer, Colorectal Cancer, Urothelial Carcinoma, Clear Cell RCC, HCC
Condition
Official Title
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
Eligibility Criteria
All
Gender
≥18 Years
Age
No
Healthy Volunteers
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 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
For the latest version of this information please go to www.forpatients.roche.com