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

May 8, 2026 updated by: Genentech, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

450

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Recruiting
        • Kinghorn Cancer Centre
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Recruiting
        • Monash Health Monash Medical Centre
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Recruiting
        • Linear Clinical Research Ltd
  • Belgium
      • Edegem, Belgium, 2650
        • Recruiting
        • UZ Antwerpen
      • Herstal, Belgium, 4040
        • Recruiting
        • CHU de Liege
      • Wilrijk, Belgium, 2610
        • Recruiting
        • GasthuisZusters Antwerpen
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Recruiting
        • British Columbia Cancer Agency
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recruiting
        • Ottawa Hospital Regional Cancer Centre
      • Toronto, Ontario, Canada, M5G 1Z5
        • Recruiting
        • Princess Margaret Cancer Centre
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Recruiting
        • Sir Mortimer B Davis Jewish General Hospital
  • Greece
      • Athens, Greece, 115 27
        • Recruiting
        • Sotiria Thoracic Diseases Hospital of Athens
    • Attica
      • Chaïdári, Attica, Greece, 124 62
        • Recruiting
        • University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA
    • Thessaloniki
      • Pavlos Melas, Thessaloniki, Greece, 564 03
        • Recruiting
        • Papageorgiou General Hospital Of Thessaloniki
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Recruiting
        • Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
      • Groningen, Netherlands, 9713 GZ
        • Recruiting
        • Universitair Medisch Centrum Groningen
  • South Korea
      • Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital
      • Seoul, South Korea, 06351
        • Recruiting
        • Samsung Medical Center - PPDS
      • Seoul, South Korea, 05505
        • Completed
        • Asan Medical Center - PPDS
      • Seoul, South Korea, 120-752
        • Recruiting
        • Severance Hospital Yonsei University Health System - Clinical Trials Center Pharmacy
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28040
        • Completed
        • START MADRID_Hospital Universiario Fundacion Jimenez Diaz
      • Málaga, Spain, 29010
        • Recruiting
        • Hospital Universitario Virgen de la Victoria
      • Valencia, Spain, 46010
        • Recruiting
        • Hospital Clínico Universitario de Valencia
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08908
        • Recruiting
        • ICO Hospitalet- Hospital Duran i Reynals
  • Sweden
      • Gothenburg, Sweden, 413 45
        • Recruiting
        • Sahlgrenska Universitetssjukhuset
      • Stokholm, Solna, Sweden, 17176
        • Recruiting
        • Karolinska Universitetssjukhuset Solna
  • Taiwan
      • Kaohsiung City, Taiwan, 807
        • Recruiting
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Taichung, Taiwan, 40201
        • Recruiting
        • Chung Shan Medical University Hospital
      • Taipei, Taiwan, 10002
        • Recruiting
        • National Taiwan University Hospital
  • United States
    • California
      • San Francisco, California, United States, 94305
        • Recruiting
        • Stanford University
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado
    • Florida
      • Sarasota, Florida, United States, 34232
        • Recruiting
        • Florida Cancer Specialists - Sarasota
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Completed
        • Winship Cancer Institute
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana Farber Cancer Institute
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Completed
        • Washington University Medical Center, Division of Oncology
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Rutgers Cancer Institute of New Jersey
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Recruiting
        • The West Clinic - Memphis (Union Ave)
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • SCRI Oncology Partners
    • Texas
      • San Antonio, Texas, United States, 98229
        • Recruiting
        • South Texas Accelerated Research Therapeutics (START)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase Ia: Dose Escalation
Participants in successive cohorts will receive escalating doses of enzelkitug, as an intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.
Drug: Enzelkitug
Enzelkitug will be administered as per the schedule specified in the respective arms.
Other Names:
  • RO7502175
Experimental: Phase Ia: Expansion
Participants with select solid tumors will receive a recommended dose of enzelkitug, determined in Phase Ia dose escalation phase as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.
Drug: Enzelkitug
Enzelkitug will be administered as per the schedule specified in the respective arms.
Other Names:
  • RO7502175
Experimental: Phase Ib: Dose Escalation
Participants in successive cohorts will receive escalating doses of enzelkitug, as an IV infusion, in combination with a fixed dose of atezolizumab, as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.
Drug: Atezolizumab
Atezolizumab will be administered as per the schedule specified in the respective arms.
Other Names:
  • Tecentriq
Drug: Enzelkitug
Enzelkitug will be administered as per the schedule specified in the respective arms.
Other Names:
  • RO7502175
Experimental: Phase Ib: Expansion
Participants with select solid tumors will receive a recommended dose of enzelkitug, determined in Phase Ib dose escalation phase, as an IV infusion, in combination with a fixed dose of atezolizumab or pembrolizumab, as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.
Drug: Pembrolizumab
Pembrolizumab will be administered as per the schedule specified in the respective arms.
Other Names:
  • Keytruda
Drug: Atezolizumab
Atezolizumab will be administered as per the schedule specified in the respective arms.
Other Names:
  • Tecentriq
Drug: Enzelkitug
Enzelkitug will be administered as per the schedule specified in the respective arms.
Other Names:
  • RO7502175

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Phase Ia: Number of Participants With Dose-limiting Toxicities (DLTs)
Time Frame: From Day 1 to Day 21 of Cycle 1 (21 days from date of first dose of study treatment) (1 Cycle=21 days)
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 DLTs
Time Frame: From Day 1 to Day 21 of Cycle 1 (21 days from date of first dose of study treatment) (1 Cycle=21 days)
From 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)
Time Frame: Up to approximately 52 months
Up to approximately 52 months
Phase Ib: Number of Participants With TEAEs
Time Frame: Up to approximately 52 months
Up to approximately 52 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Phase Ia and Phase Ib: Maximum Serum Concentration (Cmax) of Enzelkitug
Time Frame: From Cycle 1 (each cycle is 21 days) Day 1, and at multiple timepoints up to each follow-up visits (up to approximately 52 months)
From Cycle 1 (each cycle is 21 days) Day 1, and at multiple timepoints up to each follow-up visits (up to approximately 52 months)
Phase Ia and Phase Ib: Objective Response Rate (ORR)
Time Frame: From Cycle 1(each cycle is 21 days) Day 1, until disease progression, death, or end of study (up to approximately 52 months)
From Cycle 1(each cycle is 21 days) Day 1, until disease progression, death, or end of study (up to approximately 52 months)
Phase Ia and Phase Ib: Duration of Response (DOR)
Time Frame: From Cycle 1 (each cycle is 21 days) Day 1, until disease progression, death, or end of study (up to approximately 52 months)
From Cycle 1 (each cycle is 21 days) Day 1, until disease progression, death, or end of study (up to approximately 52 months)
Phase Ia and Phase Ib: Progression-free Survival (PFS)
Time Frame: From Cycle 1 (each cycle is 21 days) Day 1, until disease progression, death, or end of study (up to approximately 52 months)
From Cycle 1 (each cycle is 21 days) Day 1, until disease progression, death, or end of study (up to approximately 52 months)
Phase Ia and Phase Ib: Percentage of Participants With Anti-drug Antibody (ADA) to Enzelkitug
Time Frame: From Cycle 1 (each cycle is 21 days) Day 1, and at multiple timepoints up to treatment discontinuation (up to approximately 52 months)
From Cycle 1 (each cycle is 21 days) Day 1, and at multiple timepoints up to treatment discontinuation (up to approximately 52 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Investigators

  • Study Director: Clinical Trials, Genentech, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2022

Primary Completion (Estimated)

July 31, 2028

Study Completion (Estimated)

July 31, 2028

Study Registration Dates

First Submitted

October 12, 2022

First Submitted That Met QC Criteria

October 12, 2022

First Posted (Actual)

October 14, 2022

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 8, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GO43860
  • 2021-006708-34 (EudraCT Number)
  • 2023-504709-35-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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