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NCT05274048 · ClinicalTrials.gov registry record · Phase 1

Neratinib and Fam-Trastuzumab Deruxtecan in Advanced Gastro-esophageal Cancer Patients

A Phase 1 study of Gastric Cancer and Gastrointestinal Cancer, sponsored by Fox Chase Cancer Center.

Recruiting
Registry status
Phase 1
Development phase
18
Enrollment target
3
Study locations

NCT05274048 is a Phase 1 study of Gastric Cancer and Gastrointestinal Cancer that is actively recruiting participants, run by Fox Chase Cancer Center. The registered enrollment target is 18 participants, below the 319-participant average among 153 other Gastric Cancer trials with a reported enrollment target (94% lower). The trial reports 3 study locations across 3 states.

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The verdict

NCT05274048, a Phase 1 study of Gastric Cancer and Gastrointestinal Cancer, is actively recruiting participants, sponsored by Fox Chase Cancer Center.

RECRUITING
Registry status
Phase 1
Development phase
18 participants
Enrollment target
3
Study locations

Study Summary

This is Phase 1 dose finding trial with potential dose expansion to evaluate the safety, toxicity, recommended phase 2 dose (RP2D), and maximum tolerated dose (MTD) of Neratinib plus TDxD using a standard 3+3 dose escalation design in patients with metastatic or unresectable gastro-esophageal cancer that are HER2-overexpressing (IHC 3+ or IHC2+/ISH+) and any other gastrointestinal cancer with HER2 expression with IHC3+. Patients must have progressed or been intolerant of at least one prior line of chemotherapy + HER2 directed therapy.

Conditions Studied

Gastric Cancer Gastrointestinal Cancer HER2 Gene Mutation

Interventions

  • DRUG Neratinib Pill
  • DRUG Fam-Trastuzumab Deruxtecan-Nxki (TDxD)

Study Locations (3)

California

  • Stanford Cancer Center - Palo Alto

New York

  • Roswell Park Comprehensive Cancer Center - Buffalo

Pennsylvania

  • Fox Chase Cancer Center - Philadelphia

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2022-06-24
Est. Completion 2027-06
Phase Phase 1

Sponsor

Fox Chase Cancer Center

183 total trials

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What the Registry Record Tells You About NCT05274048

The ClinicalTrials.gov registry entry for NCT05274048 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 18 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 (94% lower). The listed sponsor is Fox Chase Cancer Center, which has 183 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Gastric Cancer appearing as the primary indexed condition, and to 2 interventions - of which Neratinib Pill is the first listed.

NCT05274048 reports 3 study locations spanning 3 distinct geographic areas - top geographies include California, New York, Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT05274048 about?

NCT05274048 is a clinical study titled "Neratinib and Fam-Trastuzumab Deruxtecan in Advanced Gastro-esophageal Cancer Patients". This is Phase 1 dose finding trial with potential dose expansion to evaluate the safety, toxicity, recommended phase 2 dose (RP2D), and maximum tolerated dose (MTD) of Neratinib plus TDxD using a standard 3+3 dose escalation design in patients with metastatic or unresectable gastro-esophageal cancer...

What is the current status of trial NCT05274048?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2022-06-24. Estimated completion is 2027-06.

What conditions does trial NCT05274048 study?

This clinical trial studies the following conditions: Gastric Cancer, Gastrointestinal Cancer, HER2 Gene Mutation.

What interventions are being tested in trial NCT05274048?

The interventions under investigation include: Neratinib Pill (DRUG), Fam-Trastuzumab Deruxtecan-Nxki (TDxD) (DRUG).

Who is sponsoring clinical trial NCT05274048?

This trial is sponsored by Fox Chase Cancer Center, which has 183 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05274048 being conducted?

This trial has 3 study locations across California, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.