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New cancer drug enzelkitug enters first human trials

NCT ID NCT05581004

Disease control Sponsor: Genentech, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 4 times

Summary

This early-phase trial is testing a new drug called enzelkitug, alone or with standard immunotherapies, in people with advanced solid tumors that have not responded to other treatments. The main goals are to check safety, find the right dose, and see if the drug shrinks tumors. About 450 participants with various cancers like lung, melanoma, and breast cancer are being enrolled.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
enzelkitug (a drug, also called RO7502175), given alone or with atezolizumab or pembrolizumab
What this could lead to
If it works, this could point toward a new treatment option for several advanced cancers that are hard to treat.
What could go wrong
This is a very early (first-in-human) trial, so safety and the right dose are still unknown. Many early cancer drugs do not end up working in larger studies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

165 people

The number who actually took part.

Started

Oct 2022

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 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

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Conditions

The condition(s) this trial relates to.

cervical cancer clear cell renal carcinoma colorectal cancer colorectal neoplasm esophageal cancer Esophageal Neoplasms gastric cancer gastric neoplasm head and neck squamous cell carcinoma hepatocellular carcinoma melanoma non-small cell lung carcinoma nonpapillary renal cell carcinoma renal cell carcinoma Squamous Cell Carcinoma of Head and Neck transitional cell carcinoma triple-negative breast carcinoma urothelial carcinoma Uterine Cervical Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cervical cancer Clear cell RCC Colorectal cancer Esophageal cancer Gastric cancer HCC HNSCC Locally advanced or metastatic solid tumors Melanoma NSCLC TNBC Urothelial carcinoma

Contacts and locations

Locations

  • Asan Medical Center - PPDS

    Seoul, 05505, South Korea

  • British Columbia Cancer Agency

    Vancouver, British Columbia, V5Z 4E6, Canada

  • CHU de Liège

    Herstal, 4040, Belgium

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Florida Cancer Specialists - Sarasota

    Sarasota, Florida, 34232, United States

  • GasthuisZusters Antwerpen

    Wilrijk, 2610, Belgium

  • Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis

    Amsterdam, 1066 CX, Netherlands

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital Universitario 12 De Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010, Spain

  • ICO l?Hospitalet ? Hospital Duran i Reynals

    L'Hospitalet de Llobregat, Barcelona, 08908, Spain

  • IDS (IDS) Pharmacist South Texas Accelerated Resear Therapeutics, LLC START

    San Antonio, Texas, 78229, United States

  • Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON

    Barcelona, 08035, Spain

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807, Taiwan

  • Karolinska Universitetssjukhuset Solna

    Stokholm, Solna, 17176, Sweden

  • Kinghorn Cancer Centre

    Darlinghurst, New South Wales, 2010, Australia

  • Linear Clinical Research Ltd

    Nedlands, Western Australia, 6009, Australia

  • Monash Health Monash Medical Centre

    Clayton, Victoria, 3168, Australia

  • Ottawa Hospital Regional Cancer Centre

    Ottawa, Ontario, K1H 8L6, Canada

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 1Z5, Canada

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901, United States

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203, United States

  • START MADRID_Hospital Universiario Fundacion Jimenez Diaz

    Madrid, 28040, Spain

  • Samsung Medical Center - PPDS

    Seoul, 06351, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital Yonsei University Health System - Clinical Trials Center Pharmacy

    Seoul, 120-752, South Korea

  • Sir Mortimer B Davis Jewish General Hospital

    Montreal, Quebec, H3T 1E2, Canada

  • Sotiria Thoracic Diseases Hospital of Athens

    Athens, 115 27, Greece

  • Stanford University

    San Francisco, California, 94305, United States

  • The West Clinic - Memphis (Union Ave)

    Germantown, Tennessee, 38138, United States

  • UZ Antwerpen

    Edegem, 2650, Belgium

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ, Netherlands

  • University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA

    Chaïdári, Attica, 124 62, Greece

  • University Of Colorado

    Aurora, Colorado, 80045, United States

  • Washington University Medical Center, Division of Oncology

    St Louis, Missouri, 63110, United States

  • Winship Cancer Institute

    Atlanta, Georgia, 30322, United States

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