Actively Recruiting
Neratinib and Fam-Trastuzumab Deruxtecan in Advanced Gastro-esophageal Cancer Patients
Led by Fox Chase Cancer Center · Updated on 2025-10-29
18
Participants Needed
3
Research Sites
257 weeks
Total Duration
On this page
Sponsors
F
Fox Chase Cancer Center
Lead Sponsor
N
National Comprehensive Cancer Network
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Neratinib and Fam-Trastuzumab Deruxtecan in Advanced Gastro-esophageal Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with unresectable or metastatic gastrointestinal cancer confirmed by biopsy
- Have measurable or evaluable disease by RECIST 1.1 criteria
- Tumors must overexpress HER2: IHC 3+ or IHC 2+/ISH+ for gastroesophageal cancer, or IHC 3+ for other GI cancers
- Received at least one prior HER2 directed therapy for metastatic/unresectable gastroesophageal cancer, completed at least 2 weeks before treatment start
- Prior or concurrent malignancies are allowed if they do not interfere with safety or efficacy assessment
- Age over 18 years
- ECOG performance status between 0 and 2
- Normal organ and marrow function as defined by specific blood count and chemistry thresholds
- Left Ventricular Ejection Fraction of 45% or higher
- Females of childbearing potential and males with partners of childbearing potential must agree to effective contraception during and after treatment
- Able and willing to swallow oral tablets
- Able to understand and willing to sign informed consent and HIPAA documents
You will not qualify if you...
- Received chemotherapy or radiotherapy within 2 weeks before treatment start or not recovered from prior treatment side effects
- Receiving other investigational agents or previously treated with TDxD
- Immunotherapy or investigational treatments not discontinued for more than 21 days before treatment
- Have untreated brain metastases; treated brain metastases must be stable for at least 4 weeks
- Have ongoing diarrhea of more than 4 bowel movements per day despite care in the past 2 weeks
- History or suspicion of interstitial lung disease or pneumonitis, or significant lung disease requiring oxygen support
- History of allergic reactions to similar drugs used in the study
- Taking medications that strongly affect Neratinib or TDxD metabolism
- Uncontrolled illness including infections, heart failure, unstable angina, arrhythmia, or psychiatric/social conditions limiting compliance
- QTcF interval prolongation above specified thresholds
- Immune deficiency including uncontrolled HIV with low CD4 count or untreated hepatitis B
- Pregnant or breastfeeding
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Stanford Cancer Center
Palo Alto, California, United States, 94304
Actively Recruiting
2
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States, 14263
Actively Recruiting
3
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Actively Recruiting
Research Team
N
Namrata Vijavergia, MD
CONTACT
T
Tanu Singh
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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