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RECRUITING Phase 1

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

NCT05581004 · View on ClinicalTrials.gov ↗

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.

Interventions

  • DRUG Pembrolizumab
  • DRUG Atezolizumab
  • DRUG RO7502175

Study Locations (20)

Other

  • UZ Antwerpen — Edegem
  • CHU de Liège — Herstal
  • GasthuisZusters Antwerpen — Wilrijk

Tennessee

  • The West Clinic - Memphis (Union Ave) — Germantown
  • SCRI Oncology Partners — Nashville

Ontario

  • Ottawa Hospital Regional Cancer Centre — Ottawa
  • Princess Margaret Cancer Centre — Toronto

California

  • Stanford University — San Francisco

Colorado

  • University Of Colorado — Aurora

Florida

  • Florida Cancer Specialists - Sarasota — Sarasota

Georgia

  • Winship Cancer Institute — Atlanta

Massachusetts

  • Dana Farber Cancer Institute — Boston

Trial Details

FieldValue
Enrollment Target 450 participants
Start Date 2022-10-20
Est. Completion 2027-02-28
Phase Phase 1

Sponsor

Genentech

206 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05581004

The ClinicalTrials.gov registry entry for NCT05581004 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 450 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genentech, which has 206 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 10 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 3 interventions — of which Pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05581004 reports 20 study locations spanning 16 distinct geographic areas — top geographies include Other, Tennessee, Ontario. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05581004 about?

NCT05581004 is a clinical study titled "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". 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...

What is the current status of trial NCT05581004?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 450 participants. The study started on 2022-10-20. Estimated completion is 2027-02-28.

What conditions does trial NCT05581004 study?

This clinical trial studies the following conditions: Colorectal Cancer, Melanoma, Gastric Cancer, Cervical Cancer, Esophageal Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05581004?

The interventions under investigation include: Pembrolizumab (DRUG), Atezolizumab (DRUG), RO7502175 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05581004?

This trial is sponsored by Genentech, which has 206 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05581004 being conducted?

This trial has 20 study locations across California, Colorado, Florida, Georgia, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial