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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Phase Ia: Dose Escalation 		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
    Enzelkitug will be administered as per the schedule specified in the respective arms.
    Other names:
    • RO7502175
Experimental
Phase Ia: Expansion 		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
    Enzelkitug will be administered as per the schedule specified in the respective arms.
    Other names:
    • RO7502175
Experimental
Phase Ib: Dose Escalation 		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
    Enzelkitug will be administered as per the schedule specified in the respective arms.
    Other names:
    • RO7502175
  • Drug: Atezolizumab
    Atezolizumab will be administered as per the schedule specified in the respective arms.
    Other names:
    • Tecentriq
Experimental
Phase Ib: Expansion 		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
    Enzelkitug will be administered as per the schedule specified in the respective arms.
    Other names:
    • RO7502175
  • Drug: Atezolizumab
    Atezolizumab will be administered as per the schedule specified in the respective arms.
    Other names:
    • Tecentriq
  • Drug: Pembrolizumab
    Pembrolizumab will be administered as per the schedule specified in the respective arms.
    Other names:
    • Keytruda

Recruiting Locations

Stanford University
San Francisco, California 94305

University Of Colorado
Aurora, Colorado 80045

Florida Cancer Specialists - Sarasota
Sarasota, Florida 34232

Dana Farber Cancer Institute
Boston, Massachusetts 02215

Henry Ford Hospital
Detroit, Michigan 48202

Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08901

The West Clinic - Memphis (Union Ave)
Germantown, Tennessee 38138

SCRI Oncology Partners
Nashville, Tennessee 37203

South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas 98229

More Details

Status
Recruiting
Sponsor
Genentech, Inc.

Study Contact

Reference Study ID Number: GO43860 https://forpatients.roche.com/
888-662-6728 (U.S. Only)
global-roche-genentech-trials@gene.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.