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ACTIVE NOT RECRUITING Phase 1

A Study to Evaluate Safety, Pharmacokinetics, & Activity of RO7496353 in Combination With a Checkpoint Inhibitor With or Without Standard-of-care Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors; Urothelial Carcinoma Substudy in Association With RO7496353 Study GO44010

NCT05867121 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to evaluate the safety and tolerability of RO7496353 in combination with a checkpoint inhibitor (CPI) with or without standard-of-care (SOC) chemotherapy in participants with locally advanced or metastatic solid tumors such as non-small cell lung cancer (NSCLC), gastric cancer (GC) and pancreatic ductal adenocarcinoma (PDAC). The substudy will evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary anti-tumor activity of RO7496353 in combination with atezolizumab in patients with locally advanced or metastatic urothelial carcinoma (UC). The parent and substudy will be conducted in 2 stages: an initial safety run-in stage and an expansion stage.

Interventions

  • DRUG Capecitabine
  • DRUG Atezolizumab
  • DRUG Nivolumab
  • DRUG RO7496353
  • DRUG S-1

Study Locations (20)

Other

  • National Cancer Center Hospital East — Chiba
  • Kanagawa Cancer Center — Kanagawa
  • Shizuoka Cancer Center — Shizuoka
  • National Cancer Center Hospital — Tokyo
  • The Cancer Institute Hospital of Japanese Foundation For Cancer Research — Tokyo
  • Auckland City Hospital — Auckland
  • Seoul National University Hospital — Seoul
  • Asan Medical Center — Seoul
  • Samsung Medical Center - PPDS — Seoul
  • The Catholic University of Korea, Seoul St. Mary's Hospital — Seoul

California

  • UCLA University of California Los Angeles — Los Angeles

Connecticut

  • Yale School of Medicine — New Haven

Pennsylvania

  • Thomas Jefferson University — Philadelphia

New South Wales

  • St Vincent'S Hospital — Darlinghurst

South Australia

  • Flinders Medical Centre — Bedford Park

Rio Grande do Sul

  • Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS) — Porto Alegre

São Paulo

  • Hospital de Câncer de Barretos — Barretos

Trial Details

FieldValue
Enrollment Target 102 participants
Start Date 2023-10-02
Est. Completion 2026-06-30
Phase Phase 1

Sponsor

Genentech

206 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05867121

The ClinicalTrials.gov registry entry for NCT05867121 describes a study currently listed as active not 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 102 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 3 conditions, with Gastric Cancer appearing as the primary indexed condition, and to 5 interventions — of which Capecitabine 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: NCT05867121 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Other, California, Connecticut. 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 NCT05867121 about?

NCT05867121 is a clinical study titled "A Study to Evaluate Safety, Pharmacokinetics, & Activity of RO7496353 in Combination With a Checkpoint Inhibitor With or Without Standard-of-care Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors; Urothelial Carcinoma Substudy in Association With RO7496353 Study GO44010". The purpose of this study is to evaluate the safety and tolerability of RO7496353 in combination with a checkpoint inhibitor (CPI) with or without standard-of-care (SOC) chemotherapy in participants with locally advanced or metastatic solid tumors such as non-small cell lung cancer (NSCLC), gastric ...

What is the current status of trial NCT05867121?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 102 participants. The study started on 2023-10-02. Estimated completion is 2026-06-30.

What conditions does trial NCT05867121 study?

This clinical trial studies the following conditions: Gastric Cancer, Non-small Cell Lung Cancer, Pancreatic Ductal Adenocarcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05867121?

The interventions under investigation include: Capecitabine (DRUG), Atezolizumab (DRUG), Nivolumab (DRUG), RO7496353 (DRUG), S-1 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05867121?

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 NCT05867121 being conducted?

This trial has 20 study locations across California, Connecticut, Pennsylvania, New South Wales, South Australia. 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