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
A Phase Ia/Ib, Open Label, Multicenter, Dose-escalation Study to Evaluate the Safety, Pharmacokinetics, and Activity of Enzelkitug as a Single Agent and in Combination With Checkpoint Inhibitor in Patients With Locally Advanced or Metastatic Solid Tumors
Sponsor: Genentech, Inc.
Listed as NCT05581004, this observational or N/A phase trial focuses on Cervical Cancer and Clear Cell RCC and remains actively recruiting participants. Sponsored by Genentech, Inc., it has been updated 38 times since 2022, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.
Status Flow
Change History
38 versions recorded-
Apr 16, 2026 — Present [daily]
Recruiting
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▶ Show 33 earlier versions
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First recorded
Oct 2022
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
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.
Contact Information
- Genentech, Inc.
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Amsterdam, Netherlands , Athens, Greece , Atlanta, United States , Aurora, United States , Barcelona, Spain , Boston, United States , Chaïdári, Greece , Clayton, Australia , Darlinghurst, Australia , Detroit, United States and 31 more locations