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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 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2026-05-11

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Enzelkitug

Enzelkitug will be administered as per the schedule specified in the respective arms.

DRUG

Atezolizumab

Atezolizumab will be administered as per the schedule specified in the respective arms.

DRUG

Pembrolizumab

Pembrolizumab will be administered as per the schedule specified in the respective arms.

Sponsors & Collaborators

  • Genentech, Inc.

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Genentech, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-20
Primary Completion
2028-07-31
Completion
2028-07-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Greece
  • Netherlands
  • South Korea
  • Spain
  • Sweden
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05581004 on ClinicalTrials.gov