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Offering New Treatment Combinations for Unresectable Gastric and Esophageal Cancer

NCT05187182 · Recruiting
About this trial

This trial is looking at how well CA-4948 works when combined with standard treatments like FOLFOX and a PD-1 inhibitor for patients with gastric and esophageal cancer that cannot be removed by surgery. The study has two main parts: Dose Escalation and Dose Expansion. In Dose Escalation, different doses of CA-4948 will be tested. In Dose Expansion, researchers will enroll patients based on their HER2 status to further understand the treatment.

Locations and contact

This trial is running at 1 location in the United States. It is currently recruiting.

United States1 location · 1 recruiting
  • Washington University School of MedicineSt Louis, MissouriRecruiting
Who to ask about joining
Patrick Grierson, M.D., Ph.D.314-747-7689grierson@wustl.edu
Who can join

This study is open to adults aged 18 and older, both men and women, who have advanced gastric or esophageal cancer that cannot be removed by surgery. Patients must not have had prior systemic treatment for their cancer. Some health criteria must be met, including good organ function and being able to understand the study information. The trial team will confirm eligibility before enrollment.

What happens during the trial

Participants will take part in one of three groups. In the Dose Escalation group, participants will take CA-4948 twice a day, along with FOLFOX and Nivolumab every two weeks. The Dose Expansion groups will use the recommended dose of CA-4948 with either FOLFOX and Nivolumab or FOLFOX, Pembrolizumab, and Trastuzumab. Each treatment cycle lasts 14 days.

The trial team

The trial is sponsored by Washington University School of Medicine, with collaboration from Curis, Inc. and The Foundation for Barnes-Jewish Hospital. Dr. Patrick Grierson is the principal investigator leading the study.

Important dates

The study started on June 2, 2023, and is expected to finish by April 30, 2029. It is currently recruiting new participants.

Additional information

The trial's ID number is NCT05187182. This is a Phase 1 trial, which means it is looking at how well the treatment works and how safe it is. The study is FDA-regulated and plans to enroll about 42 participants.

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