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Neratinib and Fam-Trastuzumab Deruxtecan for Advanced Gastro-esophageal Cancer

This study is testing a combination of two drugs, Neratinib and Fam-Trastuzumab Deruxtecan-Nxki (TDxD), for advanced gastrointestinal cancers, including stomach and esophageal cancers. You might be eligible if your cancer has a specific marker called HER2 and has progressed after at least one other treatment. The main goal is to find the safest and most effective dose of Neratinib when given with TDxD. The study aims to enroll 18 participants, but the current recruitment status is unclear. This is a Phase 1 study, meaning it's an early stage of testing to understand safety and dosing.

Study design
This is a Phase 1 dose-finding study, meaning it's an early-stage trial to find the right dose. It will enroll 18 participants using a standard 3+3 dose escalation design.
What's involved
Patients will receive Neratinib daily for 21 days and TDxD on day 1 of a 21-day treatment cycle. The study will assess the maximum tolerated dose and recommended phase II dose over 2 years.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, determining the maximum tolerated dose and recommended phase II dose, will be measured at 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05274048

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Fox Chase Cancer Center
~18 participants
Updated 2025-10-29 on ClinicalTrials.gov
What's tested:Neratinib PillFam-Trastuzumab Deruxtecan-Nxki (TDxD)

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of the combination of TDxD and Neratinib
Measured over 2 years

Conditions

Gastric Cancer
Gastrointestinal Cancer
HER2 Gene Mutation

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Where it's being run

3 sites across 3 states
California1
New York1
Pennsylvania1

Study leadership

  • Namrata Vijavergia, MD · PRINCIPAL_INVESTIGATOR · Fox Chase Cancer Center

Who to contact

Namrata Vijavergia, MD
[email protected]
215-214-1676
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Leukocytes \> 3,000/mcL
Absolute neutrophil count \> 1,500/mcL
Platelets \> 90,000/mcL
Hemoglobin \> 9 gm/dl
Total bilirubin \< 2 times institutional normal limits
AST/ALT (SGOT/SGPT) \< 5 times institutional normal limits if liver metastases and \</+ 2 times institutional normal limits otherwise
Creatinine \< 2.0mg/dL OR
Creatinine clearance \> 50 Ml/min/1.73 m2 for patients with creatinine levels above institutional normal 9. Left Ventricular Ejection Fraction ≥ 45% or lower limit of normal. 10. Chemotherapy is harmful to the human fetus. For this reason, females of childbearing potential must be willing to use an effective method of contraception, as outlined in Section 4.4, for the course of the study through at least 6 months after the last dose of study medication. Males who have women of childbearing (WOCB) partners must agree to use an effective method of contraception as outlined in Section 4.4 for the course of the study through 8 months after the last dose of study medication. 11. Patients should be willing and able to swallow oral tablet medications 12. Ability to understand and willingness to sign a written informed consent and HIPAA consent document

What this trial measures

  • Determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of the combination of TDxD and Neratinib2 years

    The rate of dose-limiting toxicities (DLTs) for Neratinib + TDxD during DLT period of 28 days, in patients with advanced gastrointestinal cancer