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
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Phase
Phase 1
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Recruitment status
Active, not recruiting
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Participants
165
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Lead sponsor
Genentech, Inc.
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Start date
2022-10-20
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Number of sites
36
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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.
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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
clinicaltrials.gov
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
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2028-07-31
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First posted
2022-10-14
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Registry last updated
2026-08-06
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Primary completion date
2028-07-31
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Start date
2022-10-20
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Actual participants
165
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Participants
165
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Participant count basis
Actual
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Protocol amendments
6
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Number of sites
36
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Genentech, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05581004
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ClinicalTrials.gov ID
NCT05581004
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Registry record
Open registry record
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Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
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  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

  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
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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

  • 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
clinicaltrials.gov

  • 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
clinicaltrials.gov

  • 2023
  • 2023-504709-35-00
  • 2021-006708-34
Sources for references
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Conditions (15)

Targets (2)