A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors

Cancer
Head and Neck Cancer
Squamous Cell Carcinoma
Solid Tumors
Advanced Solid Tumors
Lung Cancer
Non-Small Cell Lung Cancer (NSCLC)
Breast Cancer
Triple Negative Breast Cancer
Colorectal Cancer (CRC)
Gastric Cancer
Non Small Cell Lung Carcinoma
Bladder Cancer
Urothelial Carcinoma
Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Esophageal Cancer
Hepatocellular Carcinoma (HCC)
Metastatic Solid Tumors
Skin Cancer
Malignant Melanoma
Renal Cell Cancer (RCC)
Clear Cell Renal Cell Carcinoma
Melanoma
Cervical Cancer

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Basic Details

Sponsor Genentech, Inc.

Phase Phase 1

Study Identifier NCT05581004, GO43860, 2021-006708-34

Condition Locally Advanced or Metastatic Solid Tumors, NSCLC, HNSCC, Melanoma, TNBC, Esophageal Cancer, Gastric Cancer, Cervical Cancer, Colorectal Cancer, Urothelial Carcinoma, Clear Cell RCC, HCC

Official Title A Phase Ia/Ib, Open Label, Multicenter, Dose-escalation Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Checkpoint Inhibitor in Patients With Locally Advanced or Metastatic Solid Tumors

Study Summary

This is a first-in-human study to evaluate the safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of RO7502175 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.

Eligibility Criteria

Gender

All

Age

≥18 Years

Healthy Volunteers

Inclusion Criteria

Life expectancy 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 (RECIST) Version 1.1
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 RO7501275, 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, or radiotherapy, within 3 weeks prior to initiation of study treatment
Active hepatitis B or C 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 RO7502175 infusion
Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
Active or history of autoimmune disease
Prior allogeneic stem cell or organ transplantation

The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

Results Disclaimer

What is Clinical Research?

In clinical research, volunteers, researchers, and medical professionals work together toward a shared goal: better treatment outcomes for patients. Clinical trials are vital to their process. They are carefully designed and follow approved protocols.

A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors

Basic Details

Study Summary

Eligibility Criteria

What is Clinical Research?

For the latest version of this information please go to www.forpatients.roche.com

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A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors

For the latest version of this information please go to www.forpatients.roche.com