Actively Recruiting
T-Dxd in Combination With Ramucirumab as HER2 Low Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
Led by Yonsei University · Updated on 2025-07-11
58
Participants Needed
1
Research Sites
99 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase Ib/II study to identify the RP2D of T-DXd combination with Ram and to assess the safety and clinical efficacy of this combined treatment in advanced gastric cancer. The study will be conducted in two parts: Phase Ib dose escalation study to determine the MTD and RP2D of T-DXd combination and Ram, and Phase II to further evaluate the safety and tolerability of T-DXd combinations with Ram at the RP2D and determine anti-tumor activity.
CONDITIONS
Official Title
T-Dxd in Combination With Ramucirumab as HER2 Low Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide written informed consent before any study activities
- Male or female aged 19 years or older
- Histologically or cytologically confirmed metastatic or locally advanced HER2 low gastric or gastroesophageal junction adenocarcinoma (HER2 low defined as IHC 1+ or IHC 2+ without HER2 gene amplification)
- Disease progressed after first-line palliative treatment; adjuvant chemotherapy counts as first-line if recurrence is within 6 months
- Measurable or evaluable disease according to RECIST version 1.1
- ECOG performance status of 0 or 1 at study entry
- Life expectancy of at least 12 weeks as judged by the investigator
- Left ventricular ejection fraction (LVEF) of 50% or greater by echocardiogram or MUGA scan within 28 days before enrollment
- Adequate organ function with specified blood counts, liver enzymes, bilirubin, albumin, creatinine, urinary protein, and coagulation parameters
- Adequate washout periods before enrollment from prior major surgery (≥4 weeks), radiation therapy (≥4 weeks), and anticancer chemotherapy (≥3 weeks)
- Female participants of childbearing potential must have negative pregnancy test and use highly effective contraception from screening through 7 months after last study drug dose
- Non-sterilized male participants with partners of childbearing potential must use condoms with spermicide from screening to 4 months after last study drug dose
- Female participants must not donate or retrieve ova during the study and for at least 7 months after final study drug administration
You will not qualify if you...
- Anticancer treatment within 14 days before starting study treatment
- Major surgery within 28 days before starting study treatment
- More than 2 prior lines of chemotherapy
- Peripheral neuropathy of grade 2 or higher
- Multiple primary cancers within the last 3 years
- Recent history (within 6 months) of myocardial infarction, symptomatic congestive heart failure, unstable angina, clinically important arrhythmias, or recent cardiovascular event
- Corrected QT interval prolongation above 470 msec (females) or 450 msec (males) on ECG
- Gastrointestinal perforation, fistula, grade 3-4 bleeding, arterial thromboembolism, significant gastrointestinal bleeding, or venous thromboembolism within 3 months before treatment
- History or current interstitial lung disease or pneumonitis requiring steroids or suspected but not ruled out by imaging
- Significant lung illnesses, autoimmune or inflammatory disorders, or prior pneumonectomy
- Known active central nervous system metastases or carcinomatous meningitis
- Substance abuse or significant medical conditions interfering with study participation
- Spinal cord compression or active central nervous system metastases requiring corticosteroids or anticonvulsants
- Uncontrolled infection requiring intravenous antibiotics, antivirals, or antifungals
- Active primary immunodeficiency, uncontrolled HIV infection, or active hepatitis B or C infection within 28 days before treatment
- Positive hepatitis C antibody with detectable HCV RNA
- Receipt of live attenuated vaccine within 30 days before first dose of study drug
- Unresolved toxicities from prior anticancer therapy above grade 1 except alopecia
- Known allergy or hypersensitivity to study drugs or components
- History of severe hypersensitivity to other monoclonal antibodies
- Pregnant or breastfeeding or planning pregnancy
- Considered inappropriate for study by investigator
- Cirrhosis with Child-Pugh B or worse or clinically significant ascites or hepatic encephalopathy
- Serious or nonhealing wounds, ulcers, or bone fractures within 28 days prior to first dose
- Receiving chronic antiplatelet therapy except low-dose aspirin
- Uncontrolled or poorly controlled hypertension above specified limits despite treatment
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sun Young Rha
Seoul, Seoul, South Korea, 03722
Actively Recruiting
Research Team
S
SUN YOUNG RHA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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