🏛️ Verified NIH Record • Updated 2026-08-04

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 (NCT05581004)

🔵 Active, Not Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: Genentech, Inc.

🩺 Plain-English Summary (8th-Grade Level)

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 join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (10 items).

Location: Stanford University — San Francisco, California

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • 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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (36 Sites)

  • Stanford University — San Francisco, California
  • University Of Colorado — Aurora, Colorado
  • Florida Cancer Specialists - Sarasota — Sarasota, Florida
  • Winship Cancer Institute — Atlanta, Georgia
  • Dana Farber Cancer Institute — Boston, Massachusetts
  • Washington University Medical Center, Division of Oncology — St Louis, Missouri
  • Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey
  • The West Clinic - Memphis (Union Ave) — Germantown, Tennessee
  • SCRI Oncology Partners — Nashville, Tennessee
  • IDS (IDS) Pharmacist South Texas Accelerated Resear Therapeutics, LLC START — San Antonio, Texas
  • Kinghorn Cancer Centre — Darlinghurst, New South Wales
  • Monash Health Monash Medical Centre — Clayton, Victoria
  • Linear Clinical Research Ltd — Nedlands, Western Australia
  • UZ Antwerpen — Edegem,
  • CHU de Liège — Herstal,
  • GasthuisZusters Antwerpen — Wilrijk,
  • British Columbia Cancer Agency — Vancouver, British Columbia
  • Ottawa Hospital Regional Cancer Centre — Ottawa, Ontario
  • Princess Margaret Cancer Centre — Toronto, Ontario
  • Sir Mortimer B Davis Jewish General Hospital — Montreal, Quebec
  • University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA — Chaïdári, Attica
  • Sotiria Thoracic Diseases Hospital of Athens — Athens,
  • Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis — Amsterdam,
  • Universitair Medisch Centrum Groningen — Groningen,
  • Seoul National University Hospital — Seoul,

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
🏛️ View Official NIH Record ↗