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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: Recruiting Phase 1 study of Gastric Cancer and Gastrointestinal Cancer, sponsored by Fox Chase Cancer Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The rate of dose-limiting toxicities (DLTs) for Neratinib + TDxD during DLT period of 28 days, in patients with advanced gastrointestinal cancer
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2022-06-24 |
| Est. Completion | 2027-06 |
| Phase | Phase 1 |
What NCT05274048 shows while recruiting
NCT05274048 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 319-participant average among 153 other Gastric Cancer trials with a reported enrollment target (94% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05274048's enrollment target sits among peer trials
18 148th of 153 higher than 6 of 153 other Gastric Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gastric Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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