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Antibody-Drug Conjugate

Neratinib plus TDxD for Stomach Cancer

Phase 1
Recruiting
Led By Namrata Vijavergia, MD
Research Sponsored by Namrata Vijayvergia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial studies the safety/toxicity of Neratinib plus TDxD in patients with metastatic gastric cancer that are HER2-overexpressing. Those who failed prior chemo/HER2 therapy may be eligible.

Who is the study for?
This trial is for adults over 18 with advanced gastro-esophageal cancer that's HER2-overexpressing and has worsened despite previous chemotherapy and HER2 therapy. Participants need good blood counts, organ function, no severe heart issues or uncontrolled illnesses, not pregnant or breastfeeding, willing to use contraception, and able to take oral meds.Check my eligibility
What is being tested?
The study tests the combination of Neratinib (a pill) with Fam-Trastuzumab Deruxtecan-Nxki (TDxD) in a Phase 1 trial to find safe dosages. It uses a '3+3' method where small groups are given increasing doses until the maximum tolerated dose is found for patients who've had prior treatments fail.See study design
What are the potential side effects?
Potential side effects include reactions related to liver function changes, diarrhea, potential heart problems as indicated by ejection fraction requirements in eligibility criteria, possible blood count abnormalities due to marrow suppression risk factors mentioned in exclusion criteria.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of the combination of TDxD and Neratinib
Secondary outcome measures
Determine the Disease Control Rate (DCR) (CR + PR + Stable Disease (SD)) of the combination of TDxD and Neratinib
Determine the Objective Response Rate (ORR) (Complete Response (CR) + Partial Response (PR)) of the combination of TDxD and Neratinib
Determine the Overall Survival (OS) of the combination of TDxD and Neratinib
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Neratinib plus TDxDExperimental Treatment2 Interventions
Neratinib oral daily days 1-21 plus TDxD on day 1 administered intravenously of a 21 day treatment cycle.

Find a Location

Who is running the clinical trial?

Namrata VijayvergiaLead Sponsor
Fox Chase Cancer CenterLead Sponsor
227 Previous Clinical Trials
37,491 Total Patients Enrolled
National Comprehensive Cancer NetworkNETWORK
115 Previous Clinical Trials
7,617 Total Patients Enrolled

Media Library

Fam-Trastuzumab Deruxtecan-Nxki (TDxD) (Antibody-Drug Conjugate) Clinical Trial Eligibility Overview. Trial Name: NCT05274048 — Phase 1
Stomach Cancer Research Study Groups: Neratinib plus TDxD
Stomach Cancer Clinical Trial 2023: Fam-Trastuzumab Deruxtecan-Nxki (TDxD) Highlights & Side Effects. Trial Name: NCT05274048 — Phase 1
Fam-Trastuzumab Deruxtecan-Nxki (TDxD) (Antibody-Drug Conjugate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05274048 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are investigators currently recruiting individuals for this trial?

"Per clinicaltrials.gov, this research is inviting volunteers to take part in the study. It was originally made available on June 24th 2022 and most recently updated 10 days ago (7/10/2023)."

Answered by AI

What is the aggregate quantity of participants involved in this investigation?

"Affirmative. Clinicaltrials.gov illustrates that this clinical trial, which was first posted on June 24th 2022, is currently enrolling individuals. About 18 people need to be recruited from 1 facility."

Answered by AI

Has the combination of Neratinib and TDxD been granted approval by federal regulators?

"Our research team at Power ranked Neratinib plus TDxD with a score of 1, as this is only in its initial phase of testing and has limited data attesting to its safety and efficacy."

Answered by AI
~7 spots leftby Jun 2025