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ACTIVE NOT RECRUITING Phase 2

A Safety and Efficacy Study of Treatment Combinations With and Without Chemotherapy in Adult Participants With Advanced Upper Gastrointestinal Tract Malignancies

NCT05329766 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to evaluate the safety and preliminary clinical activity of treatment combinations with and without chemotherapy in participants with locally advanced unresectable or metastatic gastric, GEJ, and esophageal adenocarcinoma. Chemotherapy will consist of FOLFOX (oxaliplatin, leucovorin, fluorouracil).

Interventions

  • DRUG Fluorouracil
  • DRUG Leucovorin
  • DRUG Zimberelimab
  • DRUG Quemliclustat
  • DRUG Domvanalimab

Study Locations (20)

Other

  • UHN - Princess Margaret Cancer Centre — Toronto
  • Clínica San Carlos de Apoquindo — Las Condes
  • Bradford Hill Centro de Investigaciones Clinicas — Recoleta
  • Centro de Estudios Clínicos SAGA — Santiago

Florida

  • Florida Cancer Specialist - South — Fort Myers
  • Mayo Clinic - Jacksonville — Jacksonville
  • Florida Cancer Specialist - North — St. Petersburg

California

  • USC/Norris Comprehensive Cancer Center — Los Angeles
  • Ronald Reagan UCLA Medical Center — Santa Monica

New York

  • Memorial Sloan Kettering Cancer Center — New York
  • Columbia University — New York

Tennessee

  • SCRI Tennessee Oncology - Nashville — Nashville
  • Vanderbilt-Ingram Cancer Center — Nashville

Arizona

  • Mayo Clinic - Arizona — Phoenix

Connecticut

  • Yale Cancer Center — Derby

Massachusetts

  • Massachusetts General Hospital — Boston

Trial Details

FieldValue
Enrollment Target 332 participants
Start Date 2022-06-10
Est. Completion 2027-06
Phase Phase 2

Sponsor

Arcus Biosciences

14 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05329766

The ClinicalTrials.gov registry entry for NCT05329766 describes a study currently listed as active not recruiting. It is categorized as Phase 2, 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 332 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Arcus Biosciences, which has 14 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Gastrointestinal Tract Malignancies appearing as the primary indexed condition, and to 5 interventions — of which Fluorouracil 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: NCT05329766 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Other, Florida, California. 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 NCT05329766 about?

NCT05329766 is a clinical study titled "A Safety and Efficacy Study of Treatment Combinations With and Without Chemotherapy in Adult Participants With Advanced Upper Gastrointestinal Tract Malignancies". The purpose of this study is to evaluate the safety and preliminary clinical activity of treatment combinations with and without chemotherapy in participants with locally advanced unresectable or metastatic gastric, GEJ, and esophageal adenocarcinoma. Chemotherapy will consist of FOLFOX (oxaliplatin...

What is the current status of trial NCT05329766?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 332 participants. The study started on 2022-06-10. Estimated completion is 2027-06.

What conditions does trial NCT05329766 study?

This clinical trial studies the following conditions: Gastrointestinal Tract Malignancies. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05329766?

The interventions under investigation include: Fluorouracil (DRUG), Leucovorin (DRUG), Zimberelimab (DRUG), Quemliclustat (DRUG), Domvanalimab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05329766?

This trial is sponsored by Arcus Biosciences, which has 14 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05329766 being conducted?

This trial has 20 study locations across Arizona, California, Connecticut, Florida, 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