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New treatment option for Gastric Cancer
Official title Neratinib and Fam-Trastuzumab Deruxtecan in Advanced Gastro-esophageal Cancer Patients
ClinicalTrials.gov ID: NCT05274048
What this study is testing
What is Neratinib Pill?
Neratinib Pill is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for gastric cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must have been diagnosed with histologically or cytologically confirmed gastrointestinal cancer (esophagus, stomach, colon, biliary...
- Patients must have evaluable or measurable disease by RECIST 1.1 criteria
- 4.1.3 Patients' tumors must have HER2-overexpressing:
- (IHC 3+ or IHC2+/ISH+) advanced gastroesophageal cancer (including gastroesophageal junction adenocarcinoma).
- IHC 3+ for other GI cancers
You likely can't join if
- Patients who have had chemotherapy, or radiotherapy within 2 weeks prior to C1D1 or those who have not recovered from adverse events due to agents...
- Patients may not be receiving any other investigational agents for advanced cancer and must not have received prior treatment with TDxD
- Immunotherapy and treatments involving any investigational agents must be discontinued for \>21 days before Cycle 1 Day 1 (C1D1)
- Patients with known untreated brain metastases are excluded from this study because of their poor prognosis and frequent development of neurologic...
- Patients with ongoing diarrhea (\> 4 bowel movements/day) unresolved despite medical and best supportive care in the two weeks preceding therapy
- Patients will be excluded if they have had interstitial lung disease or pneumonitis or were suspected to have interstitial lung disease or...
See the full eligibility criteria
- Patients must have been diagnosed with histologically or cytologically confirmed gastrointestinal cancer (esophagus, stomach, colon, biliary, pancreas or unknown primary likely GI), and been deemed unresectable or have...
- Patients must have evaluable or measurable disease by RECIST 1.1 criteria
- 4.1.3 Patients' tumors must have HER2-overexpressing:
- (IHC 3+ or IHC2+/ISH+) advanced gastroesophageal cancer (including gastroesophageal junction adenocarcinoma).
- IHC 3+ for other GI cancers
- Patients must have received at least one prior line of HER2 directed therapy for metastatic/unresectable disease and completed treatment at least 2 weeks prior to C1D1 (only for Gastroesohageal cancers, not for other GI...
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible for...
- Age \> 18 years.
- ECOG performance status 0-2
- Patients must have normal organ and marrow function as defined below
- 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
- Left Ventricular Ejection Fraction ≥ 45% or lower limit of normal.
- 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...
- Patients should be willing and able to swallow oral tablet medications
- Ability to understand and willingness to sign a written informed consent and HIPAA consent document
- Patients who have had chemotherapy, or radiotherapy within 2 weeks prior to C1D1 or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier (secondary hypothyroidism from...
- Patients may not be receiving any other investigational agents for advanced cancer and must not have received prior treatment with TDxD
- Immunotherapy and treatments involving any investigational agents must be discontinued for \>21 days before Cycle 1 Day 1 (C1D1)
- Patients with known untreated brain metastases are excluded from this study because of their poor prognosis and frequent development of neurologic dysfunction that would confound the evaluation of neurologic and other...
- Patients with ongoing diarrhea (\> 4 bowel movements/day) unresolved despite medical and best supportive care in the two weeks preceding therapy
- Patients will be excluded if they have had interstitial lung disease or pneumonitis or were suspected to have interstitial lung disease or pneumonitis that could not be ruled out on imaging at screening or if they had a...
- History of allergic reactions attributed to compound of similar chemical or biologic composition to the agent(s) used in this study
- Patients receiving any medications or substances that are strong inhibitors or inducers of Neratinib and/or TDxD are ineligible.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations...
- Has a QT interval corrected by Fridericia's formula (QTcF) prolongation to \>470 msec (female people) or \>450 msec (male people) based on average of the Screening triplicate12-lead ECG.
- Any patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, including uncontrolled HIV with CD4 count \<200, untreated Hepatitis B are excluded from the...
- Pregnant or breast feeding.
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
- Buffalo, New York, United States
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, California, United States; Buffalo, New York, United States; Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.