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 | Recruiting Phase 1 FDA Drug

• 3 other identifiers: GO438602021-006708-342023-504709-35-00
• Study Type: interventional
• Target: 450
• Locations: 10 countries
• Sites: 41

Brief 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

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

Outcome Measures

Primary Outcomes (4)

• 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 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 Ia: Number of Participants With Treatment-emergent Adverse Events (TEAEs)

  Up to approximately 52 months

• Phase Ib: Number of Participants With TEAEs

  Up to approximately 52 months

Secondary Outcomes (5)

• Phase Ia and Phase Ib: Maximum Serum Concentration (Cmax) of Enzelkitug

  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)

  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)

  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)

  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

  From Cycle 1 (each cycle is 21 days) Day 1, and at multiple timepoints up to treatment discontinuation (up to approximately 52 months)

Study Arms (4)

Phase Ia: Dose Escalation

EXPERIMENTAL

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

Phase Ia: Expansion

EXPERIMENTAL

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

Phase Ib: Dose Escalation

EXPERIMENTAL

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: Enzelkitug; Drug: Atezolizumab

Phase Ib: Expansion

EXPERIMENTAL

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: Enzelkitug; Drug: Atezolizumab; Drug: Pembrolizumab

Interventions

Atezolizumab DRUG

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

Also known as: Tecentriq

Phase Ib: Dose Escalation; Phase Ib: Expansion

Pembrolizumab DRUG

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

Also known as: Keytruda

Phase Ib: Expansion

Enzelkitug DRUG

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

Also known as: RO7502175

Phase Ia: Dose Escalation; Phase Ia: Expansion; Phase Ib: Dose Escalation; Phase Ib: Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (41)

Stanford University

San Francisco, California, 94305, United States

RECRUITING

University Of Colorado

Aurora, Colorado, 80045, United States

RECRUITING

Florida Cancer Specialists - Sarasota

Sarasota, Florida, 34232, United States

RECRUITING

Winship Cancer Institute

Atlanta, Georgia, 30322, United States

COMPLETED

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

Henry Ford Hospital

Detroit, Michigan, 48202, United States

RECRUITING

Washington University Medical Center, Division of Oncology

St Louis, Missouri, 63110, United States

COMPLETED

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

RECRUITING

The West Clinic - Memphis (Union Ave)

Germantown, Tennessee, 38138, United States

RECRUITING

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

RECRUITING

South Texas Accelerated Research Therapeutics (START)

San Antonio, Texas, 98229, United States

RECRUITING

Kinghorn Cancer Centre

Darlinghurst, New South Wales, 2010, Australia

RECRUITING

Monash Health Monash Medical Centre

Clayton, Victoria, 3168, Australia

RECRUITING

Linear Clinical Research Ltd

Nedlands, Western Australia, 6009, Australia

RECRUITING

UZ Antwerpen

Edegem, 2650, Belgium

RECRUITING

CHU de Liège

Herstal, 4040, Belgium

RECRUITING

GasthuisZusters Antwerpen

Wilrijk, 2610, Belgium

RECRUITING

British Columbia Cancer Agency

Vancouver, British Columbia, V5Z 4E6, Canada

RECRUITING

Ottawa Hospital Regional Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 1Z5, Canada

RECRUITING

Sir Mortimer B Davis Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

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

Chaïdári, Attica, 124 62, Greece

RECRUITING

Papageorgiou General Hospital of Thessaloniki

Pavlos Melas, Thessaloniki, 564 03, Greece

RECRUITING

Sotiria Thoracic Diseases Hospital of Athens

Athens, 115 27, Greece

RECRUITING

Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis

Amsterdam, 1066 CX, Netherlands

RECRUITING

Universitair Medisch Centrum Groningen

Groningen, 9713 GZ, Netherlands

RECRUITING

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Asan Medical Center - PPDS

Seoul, 05505, South Korea

COMPLETED

Samsung Medical Center - PPDS

Seoul, 06351, South Korea

RECRUITING

Severance Hospital Yonsei University Health System - Clinical Trials Center Pharmacy

Seoul, 120-752, South Korea

RECRUITING

ICO Hospitalet- Hospital Duran i Reynals

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

RECRUITING

Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON

Barcelona, 08035, Spain

RECRUITING

START MADRID_Hospital Universiario Fundacion Jimenez Diaz

Madrid, 28040, Spain

COMPLETED

Hospital Universitario 12 De Octubre

Madrid, 28041, Spain

RECRUITING

Hospital Universitario Virgen de la Victoria

Málaga, 29010, Spain

RECRUITING

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

RECRUITING

Sahlgrenska Universitetssjukhuset

Gothenburg, 413 45, Sweden

RECRUITING

Karolinska Universitetssjukhuset Solna

Stokholm, Solna, 17176, Sweden

RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

RECRUITING

Chung Shan Medical University Hospital

Taichung, 40201, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, 10002, Taiwan

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Melanoma; Esophageal Neoplasms; Stomach Neoplasms; Uterine Cervical Neoplasms; Colorectal Neoplasms; Carcinoma, Transitional Cell; Carcinoma, Renal Cell

Interventions

atezolizumab; pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Adenocarcinoma; Kidney Neoplasms; Urologic Neoplasms; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: GO43860 https://forpatients.roche.com/

CONTACT

888-662-6728 (U.S. Only); global-roche-genentech-trials@gene.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 14, 2022
• Study Start: October 20, 2022
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4); BE (3); AU (3); SE (2); KR (4); TW (3); NL (2); GR (3); US (11); ES (6)