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NCT05187182 · ClinicalTrials.gov registry record · Phase 1
CA-4948 in Combination With FOLFOX/PD-1 Inhibitor +/- Trastuzumab for Untreated Unresectable Gastric and Esophageal Cancer
A Phase 1 study of Gastric Cancer and Esophageal Cancer, sponsored by Washington University School of Medicine.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
- 1
- Study location
NCT05187182 is a Phase 1 study of Gastric Cancer and Esophageal Cancer that is actively recruiting participants, run by Washington University School of Medicine. The registered enrollment target is 42 participants, below the 319-participant average among 153 other Gastric Cancer trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05187182, a Phase 1 study of Gastric Cancer and Esophageal Cancer, is actively recruiting participants, sponsored by Washington University School of Medicine.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a phase I trial of CA-4948 in combination with FOLFOX/PD-1 inhibitor with or without trastuzumab for unresectable gastric, GEJ, and esophageal cancer. During the Dose Escalation portion of the study, different dose levels of CA-4948 in combination with FOLFOX/nivolumab will be evaluated by BOIN algorithm. Dose Expansion will include Cohorts A and B. Expansion Cohort A will enroll up to 12 patients with HER2 negative gastric, GEJ, and esophageal cancer at the expansion dose of CA-4948 determined during Dose Escalation and will use the same treatment regimen of FOLFOX/nivolumab. Expansion Cohort B will investigate CA-4948 at the dose determined during Dose Escalation in combination with FOLFOX/pembrolizumab and trastuzumab in up to 12 patients with HER2 positive disease; however, the initial 6 patients will be considered safety lead-in to confirm the safety and tolerability of this combination; if determined to be safe, an additional 6 patients will be enrolled for a total of 12 in Cohort B.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Trastuzumab
- BIOLOGICAL Nivolumab
- DRUG CA-4948
- DRUG mFOLFOX7
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2023-06-02 |
| Est. Completion | 2028-06-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05187182
The ClinicalTrials.gov registry entry for NCT05187182 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 319-participant average among 153 other Gastric Cancer trials with a reported enrollment target (87% lower). The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Gastric Cancer appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT05187182 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.
Frequently Asked Questions
What is clinical trial NCT05187182 about?
NCT05187182 is a clinical study titled "CA-4948 in Combination With FOLFOX/PD-1 Inhibitor +/- Trastuzumab for Untreated Unresectable Gastric and Esophageal Cancer". This is a phase I trial of CA-4948 in combination with FOLFOX/PD-1 inhibitor with or without trastuzumab for unresectable gastric, GEJ, and esophageal cancer. During the Dose Escalation portion of the study, different dose levels of CA-4948 in combination with FOLFOX/nivolumab will be evaluated by B...
What is the current status of trial NCT05187182?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2023-06-02. Estimated completion is 2028-06-30.
What conditions does trial NCT05187182 study?
This clinical trial studies the following conditions: Gastric Cancer, Esophageal Cancer, Gastroesophageal-junction Cancer, Stomach Cancer, Esophagus Cancer.
What interventions are being tested in trial NCT05187182?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Trastuzumab (DRUG), Nivolumab (BIOLOGICAL), CA-4948 (DRUG), mFOLFOX7 (DRUG).
Who is sponsoring clinical trial NCT05187182?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05187182 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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