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NCT Number: NCT05581004

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

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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Key information

Conditions

Locally Advanced or Metastatic Solid Tumors Adenocarcinoma Carcinoma Carcinoma, Renal Cell Carcinoma, Squamous Cell Carcinoma, Transitional Cell Cervical Cancer Clear Cell RCC Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female HCC HNSCC Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Melanoma NSCLC Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Rectal Diseases Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Squamous Cell Carcinoma of Head and Neck Stomach Diseases Stomach Neoplasms TNBC Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Urothelial Carcinoma Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Kinghorn Cancer Centre, Darlinghurst, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enzelkitug

Drug

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

Other names: RO7502175

Atezolizumab

Drug

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

Other names: Tecentriq

Pembrolizumab

Drug

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

Other names: Keytruda

Primary outcomes

  1. 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)

  2. 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)

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

    Time frame: Up to approximately 52 months

  4. Phase Ib: Number of Participants With TEAEs

    Time frame: Up to approximately 52 months

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Fastest response: use the inquiry form. No email attachments https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT

Reference Study ID Number: GO43860 https://forpatients.roche.com/

CONTACT

[email protected]

888-662-6728 (U.S. Only)

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Oct 14, 2022
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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