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

Study Identifier:
GO43860
CT.gov Identifier:
NCT05581004
EudraCT Identifier:
2021-006708-34
EU Trial (CTIS) Number:
2023-504709-35-00
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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Study Summary

To evaluate the safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of RO7502175 when administered as a single agent and in combination with atezolizumab 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, urothelial carcinoma (UC), clear cell renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC).

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Solid Tumor
Non-Small Cell Lung Cancer
Head & Neck
Melanoma
Breast Cancers
Esophageal
Gastric
Cervical cancer
Bowel (Colorectal)
Urinary tract
Renal
Liver
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I
Sex
Female & Male
Age
18 - 64 Years
Study Drug
Drug: Experimental: Phase Ia: Dose Escalation
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting

Requirements information
Inclusion criteria
  • Life expectancy of at least 12 weeksEastern Cooperative Oncology Group (ECOG) performance status of 0 or 1Measurable 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 malignancyTumor 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 atezolizumabAny anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, and/or radiotherapy, within 3 weeks prior to initiation of study treatmentActive hepatitis B (HBV) or hepatitis C (HCV) or tuberculosisPositive test for human immunodeficiency virus (HIV) infectionAcute or chronic active Epstein-Barr virus (EBV) infection at screeningAdministration of a live, attenuated vaccine (e.g., FluMist) within 4 weeks before first enzelkitug infusionSymptomatic, untreated, or actively progressing central nervous system (CNS) metastasesActive or history of autoimmune diseasePrior allogeneic stem cell or organ transplantation

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START San Antonio
San Antonio, TX, United States, 78229
Investigator
Amita Patnaik
Status
Recruiting
Condition(s) Treated at Site
Solid Tumor
Non-Small Cell Lung Cancer
Head & Neck
Melanoma
Breast Cancers
Esophageal
Gastric
Cervical cancer
Bowel (Colorectal)
Urinary tract
Renal
Liver
Location
START Madrid, Spain (FJD)
Madrid, Spain, 28040
Investigator
Victor Moreno Garcia
Status
Recruiting
Condition(s) Treated at Site
Solid Tumor
Non-Small Cell Lung Cancer
Head & Neck
Melanoma
Breast Cancers
Esophageal
Gastric
Cervical cancer
Bowel (Colorectal)
Urinary tract
Renal
Liver