Clinical trial for Gastric Adenocarcinoma
Official title A Study of TRK-950 When Used in Combination With Ramucirumab and Paclitaxel in Patients With Gastric Cancer
ClinicalTrials.gov ID: NCT06038578
What this study is testing
What is TRK-950?
TRK-950 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for gastric adenocarcinoma.
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 study will assess the efficacy, safety, optimal dose and ADA and NAbs development of TRK-950 at two separate dose levels in combination with ramucirumab and paclitaxel (RAM+PTX) as compared with RAM + PTX treatment alone in participants with gastric or gastro-esophageal junction (GEJ) adenocarcinoma.
- 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 and older
You may be able to join if
- Histologically or cytologically confirmed metastatic, or locally advanced and unresectable gastric or GEJ adenocarcinoma.
- The patient is eligible to receive Ramucirumab + Paclitaxel.
- Documented objective radiographic or clinical disease progression (e.g., any new or worsening malignant effusion documented by ultrasound...
- First treatment for metastatic disease or locally advanced disease without experiencing adjuvant / neo-adjuvant treatment, which progressed during...
- Adjuvant / neo-adjuvant treatment which progressed more than 6 months after the last dose of treatment and first treatment for metastatic disease or...
You likely can't join if
- Prior history of treatment with ramucirumab or paclitaxel.
- HER2 positive gastric or GEJ adenocarcinoma.
- Major surgery within 28 days prior to randomization.
- Baseline corrected QT (QTc) interval of \> 470 msec for females and \> 450 msec for males calculated using Fridericia's formula.
- New York Heart Association (NYHA) Class II - IV symptomatic congestive heart failure, or symptomatic or poorly controlled cardiac arrhythmia.
- The patient has experienced any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient...
See the full eligibility criteria
- Histologically or cytologically confirmed metastatic, or locally advanced and unresectable gastric or GEJ adenocarcinoma.
- The patient is eligible to receive Ramucirumab + Paclitaxel.
- Documented objective radiographic or clinical disease progression (e.g., any new or worsening malignant effusion documented by ultrasound examination) which may be confirmed by pathologic criteria (histology and/or...
- First treatment for metastatic disease or locally advanced disease without experiencing adjuvant / neo-adjuvant treatment, which progressed during treatment or within 4 months after the last dose of treatment
- Adjuvant / neo-adjuvant treatment which progressed more than 6 months after the last dose of treatment and first treatment for metastatic disease or locally advanced disease, which progressed during the treatment or...
- Adjuvant / neo-adjuvant treatment which progressed during treatment or within 6 months after the last dose of treatment
- Adjuvant / neo-adjuvant treatment which progressed during treatment or within 6 months after the last dose of treatment and first treatment for metastatic disease or locally advanced disease, which progressed during...
- Presence of primary or metastatic disease, measurable per RECIST v1.1 on CT scan.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Life expectancy of at least 3 months.
- Age ≥ 18 years in the US and Japan, and ≥ 19 years of age in Korea.
- Signed, written IRB-approved informed consent.
- Adequate organ function from specimens collected within 14 days prior to Day 1.
- For men and women of child-producing potential, the use of effective contraceptive methods during the study and for 6 months after the last dose of TRK-950.
- All patients must sign a pre-screening consent to assess tumor tissue to determine eligibility. Tumor tissue must be evaluable for CAPRIN-1 staining at a CLIA certified laboratory and meet or exceed the cutoff value...
- Prior history of treatment with ramucirumab or paclitaxel.
- HER2 positive gastric or GEJ adenocarcinoma.
- Major surgery within 28 days prior to randomization.
- Baseline corrected QT (QTc) interval of \> 470 msec for females and \> 450 msec for males calculated using Fridericia's formula.
- New York Heart Association (NYHA) Class II - IV symptomatic congestive heart failure, or symptomatic or poorly controlled cardiac arrhythmia.
- The patient has experienced any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 3 months prior to randomization.
- The patient has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
- Clinically symptomatic venous thromboembolism or current treatment with anti-coagulants. (Patients receiving prophylactic and low-dose anticoagulation therapy are eligible provided that the coagulation parameter defined...
- Uncontrolled arterial hypertension ≥ 150 mmHg (systolic) or ≥ 90 mmHg (diastolic) despite standard medical management.
- Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
- Pregnant or nursing women.
- Treatment with radiation therapy within 2 weeks, or treatment with chemotherapy, immunotherapy, targeted therapy, or investigational therapy within 4 weeks prior to randomization (within 2 weeks for Oral FU (S1 and...
- The patient has significant bleeding disorders, vasculitis, or had a significant bleeding episode from the gastrointestinal tract within 3 months prior to randomization.
- Clinically significant ascites, paracentesis in the last 3 months, or undergoes regular paracentesis procedures.
- History of gastrointestinal perforation and/or fistulae within 6 months prior to randomization.
- The patient has a serious or non-healing wound, peptic ulcer, or bone fracture within 28 days prior to randomization.
- The patient has a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection (e.g., hemicolectomy or extensive small intestine resection with chronic diarrhea), Crohn's disease...
- Known active infection with HIV, hepatitis B or hepatitis C. Patients with a history of hepatitis B or C are allowed if HBV DNA or Hep C RNA are undetectable.
- The patient is currently enrolled in a clinical trial involving an investigational product or non-approved use of a drug, or concurrently enrolled in any other type of medical research judged not to be scientifically or...
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Irvine, California, United States
- Santa Monica, California, United States
- Arlington, Texas, United States
- Bedford, Texas, United States
- Dallas, Texas, United States
- Fort Worth, Texas, United States
- Grapevine, Texas, United States
- Plano, Texas, United States
- Yokohama, Kanagawa, Japan
- Shinden, Saitama, Japan
- Nagaizumi-cho, Shizuoka, Japan
- Chūōku, Japan
- Kashiwa, Japan
- Kōtoku, Japan
- Seongnam-si, Gyeonggi-do, South Korea
- Hwasun, Jeollanam-do, South Korea
- Daegu, South Korea
- Seoul, South Korea
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 Duarte, California, United States; Irvine, California, United States; Santa Monica, California, United States; Arlington, Texas, United States; Bedford, Texas, United States; Dallas, Texas, United States and 13 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.