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NCT05581004 · ClinicalTrials.gov record · last posted 2026-08-06

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

StatusActive, Not Recruiting
PhasePhase 1
Started2022-10-20
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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.

Protocol amendment history 6 changes detected by DataLookout

2026-08-07
Enrollment closed, study ongoing
2026-08-07
Enrollment reduced: 450 → 165 participants
2026-08-07
Trial sites reduced: 41 → 36 locations
2026-04-16
Primary endpoint(s) modified
WasPhase Ia: Number of Participants with Dose Limiting Toxicities (DLTs), Phase Ia: Number of Participants with Treatment Emergent Adverse Events, Phase Ib: Number of Participants with DLTs, Phase Ib: Number of Participants with Treatment Emergent Adverse Events
NowPhase Ia: Number of Participants With Dose-limiting Toxicities (DLTs), Phase Ia: Number of Participants With Treatment-emergent Adverse Events (TEAEs), Phase Ib: Number of Participants With DLTs, Phase Ib: Number of Participants With TEAEs
2026-04-16
Primary completion pushed: 2027-02-28 → 2028-07-31
2026-04-16
Completion pushed: 2027-02-28 → 2028-07-31
Trial Details
NCT Number NCT05581004
Lead Sponsor Genentech, Inc.
Conditions Locally Advanced or Metastatic Solid Tumors, NSCLC, HNSCC, Melanoma, TNBC, Esophageal Cancer, Gastric Cancer, Cervical Cancer +4 more
Enrollment 165 participants
Start Date 2022-10-20
Primary Completion 2028-07-31 (estimated)
Study Completion 2028-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-06