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A Study of Enzelkitug for Advanced Solid Tumors

This study is testing a new drug called enzelkitug, both alone and in combination with atezolizumab or pembrolizumab, for people with locally advanced or metastatic (spread) solid tumors. This includes specific cancers like non-small cell lung cancer, head and neck cancer, melanoma, and triple-negative breast cancer. Researchers want to understand how safe enzelkitug is, how your body processes it, and if it can help shrink tumors. You may be able to join if you are an adult with a solid tumor that has spread, have a life expectancy of at least 12 weeks, and your disease can be measured. The study is currently recruiting up to 450 participants, but its overall status is unclear.

Study design
This is a first-in-human interventional study, meaning it's the first time enzelkitug is being tested in people. It will enroll up to 450 participants in two stages: dose escalation and dose expansion.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for treatment-emergent adverse events (side effects) for up to approximately 52 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05581004

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

Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatment
Genentech, Inc.
~165 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:EnzelkitugAtezolizumabPembrolizumab

At a glance

Recruiting sites
0 of 36 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase Ia: Number of Participants With Dose-limiting Toxicities (DLTs)
Measured over From Day 1 to Day 21 of Cycle 1 (21 days from date of first dose of study treatment) (1 Cycle=21 days)
+3 more outcomes measured

Conditions

Locally Advanced or Metastatic Solid Tumors
NSCLC
HNSCC
Melanoma
TNBC
Esophageal Cancer
Gastric Cancer
Cervical Cancer
Colorectal Cancer
Urothelial Carcinoma
Clear Cell RCC
HCC

Explore related trials

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Where it's being run

36 sites across 24 states
Spain5
South Korea4
Belgium3
Tennessee2
Ontario2
Netherlands2
California1
Colorado1

Study leadership

  • Clinical Trials · STUDY_DIRECTOR · Genentech, Inc.

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Phase Ia: Number of Participants With Dose-limiting Toxicities (DLTs)From Day 1 to Day 21 of Cycle 1 (21 days from date of first dose of study treatment) (1 Cycle=21 days)
  • Phase Ib: Number of Participants With DLTsFrom Day 1 to Day 21 of Cycle 1 (21 days from date of first dose of study treatment) (1 Cycle=21 days)
  • Phase Ia: Number of Participants With Treatment-emergent Adverse Events (TEAEs)Up to approximately 52 months
  • Phase Ib: Number of Participants With TEAEsUp to approximately 52 months