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RecruitingInterventionalPhase 1

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

NCT ID: NCT05581004Sponsor: Genentech, Inc.Last updated: 2026-06-09

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.

Arms & interventions

  • DrugEnzelkitug

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

  • DrugAtezolizumab

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

  • DrugPembrolizumab

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

Outcome measures

Primary

  • 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)

  • 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)

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

    Time frame: Up to approximately 52 months

  • Phase Ib: Number of Participants With TEAEs

    Time frame: Up to approximately 52 months

Secondary

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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

Study locations (11)

Stanford University

San Francisco, California, 94305

Recruiting

University Of Colorado

Aurora, Colorado, 80045

Recruiting

Florida Cancer Specialists - Sarasota

Sarasota, Florida, 34232

Recruiting

Winship Cancer Institute

Atlanta, Georgia, 30322

Completed

Dana Farber Cancer Institute

Boston, Massachusetts, 02215

Recruiting

Henry Ford Hospital

Detroit, Michigan, 48202

Recruiting

Washington University Medical Center, Division of Oncology

St Louis, Missouri, 63110

Completed

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901

Recruiting

The West Clinic - Memphis (Union Ave)

Germantown, Tennessee, 38138

Recruiting

SCRI Oncology Partners

Nashville, Tennessee, 37203

Recruiting

South Texas Accelerated Research Therapeutics (START)

San Antonio, Texas, 98229

Recruiting
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 | Cancerify