Locally Advanced or Metastatic Solid TumorsPhase 1NCT05581004
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
A Phase 1 study testing Enzelkitug, Atezolizumab and Pembrolizumab in people with Locally Advanced or Metastatic Solid Tumors and NSCLC, run by Genentech, Inc. at 36 sites in 10 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced or Metastatic Solid Tumors, NSCLC, HNSCC
- What is being tested?
- Enzelkitug, Atezolizumab and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 36 sitesin 10 countries
- Study dates
- 20 Oct 2022to 31 Jul 2028
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
- Active or history of autoimmune disease
- Prior allogeneic stem cell or organ transplantation
Trial locations and contacts
36 sites in 10 countries.
36 sites in 10 countries
United States10 sites
Winship Cancer Institute
Atlanta, Georgia, 30322
University Of Colorado
Aurora, Colorado, 80045
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
The West Clinic - Memphis (Union Ave)
Germantown, Tennessee, 38138
SCRI Oncology Partners
Nashville, Tennessee, 37203
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
IDS (IDS) Pharmacist South Texas Accelerated Resear Therapeutics, LLC START
San Antonio, Texas, 78229
Stanford University
San Francisco, California, 94305
Florida Cancer Specialists - Sarasota
Sarasota, Florida, 34232
Washington University Medical Center, Division of Oncology
St Louis, Missouri, 63110
Spain6 sites
Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON
Barcelona, 08035
ICO l?Hospitalet ? Hospital Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, 08908
START MADRID_Hospital Universiario Fundacion Jimenez Diaz
Madrid, 28040
Hospital Universitario 12 De Octubre
Madrid, 28041
Hospital Universitario Virgen de la Victoria
Málaga, 29010
Hospital Clinico Universitario de Valencia
Valencia, 46010
Canada4 sites
Sir Mortimer B Davis Jewish General Hospital
Montreal, Quebec, H3T 1E2
Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario, K1H 8L6
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 1Z5
British Columbia Cancer Agency
Vancouver, British Columbia, V5Z 4E6
South Korea4 sites
Seoul National University Hospital
Seoul, 03080
Asan Medical Center - PPDS
Seoul, 05505
Samsung Medical Center - PPDS
Seoul, 06351
Severance Hospital Yonsei University Health System - Clinical Trials Center Pharmacy
Seoul, 120-752
Australia3 sites
Monash Health Monash Medical Centre
Clayton, Victoria, 3168
Kinghorn Cancer Centre
Darlinghurst, New South Wales, 2010
Linear Clinical Research Ltd
Nedlands, Western Australia, 6009
Belgium3 sites
UZ Antwerpen
Edegem, 2650
CHU de Liège
Herstal, 4040
GasthuisZusters Antwerpen
Wilrijk, 2610
Greece2 sites
Sotiria Thoracic Diseases Hospital of Athens
Athens, 115 27
University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA
Chaïdári, Attica, 124 62
Netherlands2 sites
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
Amsterdam, 1066 CX
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ
Taiwan1 site
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
About this study
Official title: 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.
- Conditions
- Locally Advanced or Metastatic Solid Tumors, NSCLC, HNSCC, Melanoma, TNBC, Esophageal Cancer
- Being tested
- Enzelkitug, Atezolizumab, Pembrolizumab
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Melanoma, Esophageal Neoplasms, Stomach Neoplasms, Uterine Cervical Neoplasms, Colorectal Neoplasms, Carcinoma, Transitional Cell, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnzelkitugDrug
Also called RO7502175
Enzelkitug will be administered as per the schedule specified in the respective arms.
AtezolizumabDrug
Also called Tecentriq
Atezolizumab will be administered as per the schedule specified in the respective arms.
PembrolizumabDrug
Also called Keytruda
Pembrolizumab will be administered as per the schedule specified in the respective arms.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Enzelkitug; Drug: Atezolizumab; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase Ia: Number of Participants With Dose-limiting Toxicities (DLTs)
Measured: 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
Measured: 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)
Measured: Up to approximately 52 months
Phase Ib: Number of Participants With TEAEs
Measured: Up to approximately 52 months
Secondary outcomes (5)
Phase Ia and Phase Ib: Maximum Serum Concentration (Cmax) of Enzelkitug
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: From Cycle 1 (each cycle is 21 days) Day 1, and at multiple timepoints up to treatment discontinuation (up to approximately 52 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start20 Oct 2022
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced or Metastatic Solid TumorsStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05581004
- Sponsor's protocol ID
- GO43860
- Other IDs
- 2021-006708-34, 2023-504709-35-00, 2023
- Status last verified
- Aug 2026
- First submitted
- 12 Oct 2022
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No