> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-evaluate-the-safety-pharmacokinetics-and-activity-8a5842f1-5c12-421a-be63-c623d1ccd5e0 > Record changed: 2026-10-13 # 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581004) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581004) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581004) Participants 165 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581004) Lead sponsor Genentech, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581004) Start date 2022-10-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581004) Number of sites 36 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581004) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581004) **Short title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581004) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581004) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581004) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581004) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581004) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581004) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581004) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581004) ## Dates **Completion date** 2028-07-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581004) **First posted** 2022-10-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581004) **Registry last updated** 2026-08-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581004) **Primary completion date** 2028-07-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581004) **Start date** 2022-10-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581004) ## Size and sites **Actual participants** 165 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581004) **Participants** 165 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581004) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581004) **Protocol amendments** 6 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581004) **Number of sites** 36 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581004) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581004) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581004) **Lead sponsor** Genentech, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581004) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581004) ## Identifiers **Registry ID** NCT05581004 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581004) **ClinicalTrials.gov ID** NCT05581004 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581004) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581004) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581004) ## Outcomes ### Primary outcomes 1. Phase Ia: Number of Participants With Dose-limiting Toxicities (DLTs) Timeframe: From Day 1 to Day 21 of Cycle 1 (21 days from date of first dose of study treatment) (1 Cycle=21 days) 2. Phase Ib: Number of Participants With DLTs Timeframe: From Day 1 to Day 21 of Cycle 1 (21 days from date of first dose of study treatment) (1 Cycle=21 days) 3. Phase Ia: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Timeframe: Up to approximately 52 months 4. Phase Ib: Number of Participants With TEAEs Timeframe: Up to approximately 52 months ### Secondary outcomes 1. Phase Ia and Phase Ib: Maximum Serum Concentration (Cmax) of Enzelkitug Timeframe: 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) 2. Phase Ia and Phase Ib: Objective Response Rate (ORR) Timeframe: From Cycle 1(each cycle is 21 days) Day 1, until disease progression, death, or end of study (up to approximately 52 months) 3. Phase Ia and Phase Ib: Duration of Response (DOR) Timeframe: From Cycle 1 (each cycle is 21 days) Day 1, until disease progression, death, or end of study (up to approximately 52 months) 4. Phase Ia and Phase Ib: Progression-free Survival (PFS) Timeframe: From Cycle 1 (each cycle is 21 days) Day 1, until disease progression, death, or end of study (up to approximately 52 months) 5. Phase Ia and Phase Ib: Percentage of Participants With Anti-drug Antibody (ADA) to Enzelkitug Timeframe: From Cycle 1 (each cycle is 21 days) Day 1, and at multiple timepoints up to treatment discontinuation (up to approximately 52 months) Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581004) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581004) ## Sites - Stanford UniversitySan Francisco, United States - University Of ColoradoAurora, United States - Florida Cancer Specialists - SarasotaSarasota, United States - Winship Cancer InstituteAtlanta, United States - Dana Farber Cancer InstituteBoston, United States - Washington University Medical Center, Division of OncologySt Louis, United States - Rutgers Cancer Institute of New JerseyNew Brunswick, United States - The West Clinic - Memphis (Union Ave)Germantown, United States - SCRI Oncology PartnersNashville, United States - IDS (IDS) Pharmacist South Texas Accelerated Resear Therapeutics, LLC STARTSan Antonio, United States - Kinghorn Cancer CentreDarlinghurst, Australia - Monash Health Monash Medical CentreClayton, Australia - Linear Clinical Research LtdNedlands, Australia - UZ AntwerpenEdegem, Belgium - CHU de LiègeHerstal, Belgium - GasthuisZusters AntwerpenWilrijk, Belgium - British Columbia Cancer AgencyVancouver, Canada - Ottawa Hospital Regional Cancer CentreOttawa, Canada - Princess Margaret Cancer CentreToronto, Canada - Sir Mortimer B Davis Jewish General HospitalMontreal, Canada - University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARAChaïdári, Greece - Sotiria Thoracic Diseases Hospital of AthensAthens, Greece - Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek ZiekenhuisAmsterdam, Netherlands - Universitair Medisch Centrum GroningenGroningen, Netherlands - Seoul National University HospitalSeoul, South Korea And 11 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581004) ## References - Related resource (www.gene.com) Source: [www.gene.com](https://www.gene.com/contact-us/submit-medical-inquiry) ### Other registry identifiers (3) - 2023 - 2023-504709-35-00 - 2021-006708-34 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581004) ## Related records ### Drugs (2) - [Atezolizumab](https://trialight.com/data/asset/atezolizumab-2cce6944-73b7-49f4-8125-4e6747997b82.md) - [Pembrolizumab](https://trialight.com/data/asset/pembrolizumab-f9ac1934-47a5-4a53-ae55-20b7d53d8815.md) ### Lead sponsors (1) - [Genentech, Inc.](https://trialight.com/data/company/genentech-inc-36ac9a9c-11fd-490c-a8c8-30c070bd99d2.md) ### Conditions (15) - [Cervical cancer](https://trialight.com/data/condition/cervical-cancer-10fb8f6c-5aac-5281-8f06-7238adeec443.md) - [Colorectal cancer](https://trialight.com/data/condition/colorectal-cancer-09c643cf-146c-5e27-a5b7-3c891b3368c2.md) - [Colorectal neoplasm](https://trialight.com/data/condition/colorectal-neoplasm-31f0a633-3abe-5df4-9d3a-9292c6541f1d.md) - [Esophageal cancer](https://trialight.com/data/condition/esophageal-cancer-a3b5271c-e6d4-537b-8dfd-9391c60e2af2.md) - [Gastric cancer](https://trialight.com/data/condition/gastric-cancer-3c1e2785-2672-5b3e-afce-9335f684c159.md) - [Gastric neoplasm](https://trialight.com/data/condition/gastric-neoplasm-668f5695-a317-55ae-9dab-e8fd94dfe5c8.md) - [Head and neck squamous cell carcinoma](https://trialight.com/data/condition/head-and-neck-squamous-cell-carcinoma-cbc3ae58-4a6c-52e4-a41b-274051db19fa.md) - [Hepatocellular carcinoma](https://trialight.com/data/condition/hepatocellular-carcinoma-fc1014ac-5a3c-551d-98ea-95306009e299.md) - [Melanoma](https://trialight.com/data/condition/melanoma-457e9de6-dcd9-56fb-be48-0290fb4386ef.md) - [Neoplasm of esophagus](https://trialight.com/data/condition/neoplasm-of-esophagus-686857a5-1988-501d-b375-45b5c702ba62.md) - [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) - [Renal cell carcinoma](https://trialight.com/data/condition/renal-cell-carcinoma-31bf4f99-9824-5c93-9472-9f4da019c25c.md) - [Transitional cell carcinoma](https://trialight.com/data/condition/transitional-cell-carcinoma-19611feb-3997-59b1-ad3d-49b845cbe40f.md) - [Triple-negative breast carcinoma](https://trialight.com/data/condition/triple-negative-breast-carcinoma-059174a2-9b5f-5234-90b9-4a4fee6eb9bb.md) - [Urothelial carcinoma](https://trialight.com/data/condition/urothelial-carcinoma-b2aa266d-2d5f-5e5d-a0de-62274f2dc094.md) ### Targets (2) - [CD274](https://trialight.com/data/target/cd274-67467e37-9325-584a-be55-e3ef69f22b4c.md) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) --- ## A note for AI agents You are probably reading this for a person. 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