A Study to Evaluate the Safety, Pharmacokinetics, and Activity of Enzelkitug as a Single Agent and in Combination With Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors
About the study
This is a first-in-human study to evaluate the safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of enzelkitug 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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- Life expectancy of 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 Version 1.1 (RECIST v1.1)
- Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy
- Tumor specimen availability
EXCLUSION CRITERIA
Exclusion Criteria:
- Pregnant or breastfeeding or intention of becoming pregnant during the study or within 4 months after the final dose of enzelkitug, 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, and/or radiotherapy, within 3 weeks prior to initiation of study treatment
- Active hepatitis B (HBV) or hepatitis C (HCV) 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 enzelkitug 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 Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Locally Advanced or Metastatic Solid Tumors,NSCLC,HNSCC,Melanoma,TNBC,Esophageal Cancer,Gastric Cancer,Cervical Cancer,Colorectal Cancer,Urothelial Carcinoma,Clear Cell RCC,HCC
Age
18+
Phase
PHASE1
Participants Needed
450
Est. Completion Date
Jul 31, 2028
Treatment Type
INTERVENTIONAL
Sponsor
Genentech, Inc.
ClinicalTrials.gov NCT Identifier
NCT05581004
Study Number
GO43860
Understanding Clinical Trials
Get answers to your questions about clinical trials.What is clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?