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Tests treatment safety and results for Gastric Cancer
Official title Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03)
ClinicalTrials.gov ID: NCT04379596
What this study is testing
What is Fluorouracil (5-FU)?
Fluorouracil (5-FU) is an investigational medicine, given as an 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
- DESTINY-Gastric03 will investigate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of trastuzumab deruxtecan (T-DXd) alone or in combination with chemotherapy and/or immunotherapy in HER2-expressing advanced/metastatic gastric/gastroesophageal junction (GEJ) and esophageal adenocarcinoma patients. Study hypotheses: Combination of T-DXd with cytotoxic chemotherapy and/or immunotherapy administered to subjects at the recommended phase 2 dose will show manageable safety and tolerability and preliminary anti-tumor efficacy so as to permit further clinical testing.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 130
You may be able to join if
- Male and female participants must be at least 18 years of age. Other age restrictions may apply as per local regulations
- Disease Characteristics:
- Locally advanced, unresectable, or metastatic disease based on most recent imaging
- For Part 1, 2, 3a, 4a pathologically documented adenocarcinoma of the stomach/GEJ/esophagus, HER2-positive (IHC 3+ or IHC 2+/ISH+) based on local...
- For Part 3b,4b and Part 5, pathologically documented adenocarcinoma of the stomach/GEJ/esophagus, HER2-low (IHC 2+/ISH-negative or IHC 1+) based on...
You likely can't join if
- Part 1 to 4: History of active primary immunodeficiency, known HIV, active chronic, or past hepatitis B infection, or hepatitis C infection. Part 5...
- Uncontrolled intercurrent illness.
- History of non-infectious pneumonitis/ILD, current ILD, or where suspected ILD that cannot be ruled out by imaging at screening.
- Lung-specific intercurrent clinically significant severe illnesses.
- Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals.
- Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy...
See the full eligibility criteria
- Male and female participants must be at least 18 years of age. Other age restrictions may apply as per local regulations
- Disease Characteristics:
- Locally advanced, unresectable, or metastatic disease based on most recent imaging
- For Part 1, 2, 3a, 4a pathologically documented adenocarcinoma of the stomach/GEJ/esophagus, HER2-positive (IHC 3+ or IHC 2+/ISH+) based on local tissue testing results
- For Part 3b,4b and Part 5, pathologically documented adenocarcinoma of the stomach/GEJ/esophagus, HER2-low (IHC 2+/ISH-negative or IHC 1+) based on local tissue testing results
- For Part 1, progression on or after at least one prior trastuzumabcontaining regimen For Part 2, Part 3, Part 4 and Part 5, previously untreated for unresectable or metastatic adenocarcinoma of the stomach/GEJ/...
- Has measurable target disease assessed by the Investigator based on RECIST version 1.1
- Has protocol defined adequate bone marrow and organ function including cardiac, renal and hepatic function
- If of reproductive potential, agrees to use a highly effective form of contraception or avoid intercourse during and upon completion of the study.
- Part 1 to 4: History of active primary immunodeficiency, known HIV, active chronic, or past hepatitis B infection, or hepatitis C infection. Part 5: evidence of active, uncontroled HIV, HBV or HCV infection.
- Uncontrolled intercurrent illness.
- History of non-infectious pneumonitis/ILD, current ILD, or where suspected ILD that cannot be ruled out by imaging at screening.
- Lung-specific intercurrent clinically significant severe illnesses.
- Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals.
- Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART).
- Has spinal cord compression or clinically active central nervous system metastases.
The study team makes the final eligibility decision.
Where it's taking place
- Santa Monica, California, United States
- Westwood, Kansas, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Houston, Texas, United States
- Fairfax, Virginia, United States
- Florianópolis, Brazil
- Londrina, Brazil
- Natal, Brazil
- Porto Alegre, Brazil
- Ribeirão Preto, Brazil
- Rio de Janeiro, Brazil
- Santa Maria, Brazil
- São Jose Do Rio Preto, Brazil
- São Paulo, Brazil
- Edmonton, Alberta, Canada
- Ottawa, Ontario, Canada
+ 57 more site(s).
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 to 130 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Santa Monica, California, United States; Westwood, Kansas, United States; Baltimore, Maryland, United States; Boston, Massachusetts, United States; Ann Arbor, Michigan, United States; New York, New York, United States and 71 more location(s). 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.