Gastric AdenocarcinomaPhase 2NCT06038578
A Study of TRK-950 When Used in Combination With Ramucirumab and Paclitaxel in Patients With Gastric Cancer
A Phase 2 study testing TRK-950, Ramucirumab and Paclitaxel in people with Gastric Adenocarcinoma and Gastric Cancer, run by Toray Industries, Inc at 27 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Adenocarcinoma, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- TRK-950, Ramucirumab and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 27 sitesin 3 countries
- Study dates
- 4 Oct 2023to 31 Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 cytology) if appropriate, during or after treatment. The prior treatment must meet one of the following criteria with the following treatment history:
- 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 within 4 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
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- 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 treatment or within 4 months after the last dose of treatment
- 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 (30% at ≥ 2+ staining) as defined in the expression level requirements.
Who cannot join
- 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.
Show all 19Show fewer
- 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 in the Inclusion Criterion 9 is met.)
- 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 capecitabine)).
- 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, ulcerative colitis, or chronic diarrhea.
- 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 medically compatible with this study. Patients who have recently discontinued dosing of study drug are eligible to participate as long as the final dose of study drug was ≥ 28 days from randomization for participation in this study. Patients participating in surveys or observational studies are eligible to participate in this study.
Trial locations and contacts
27 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
(Asia sites)Toray Contact for Clinical Trial Information contact
27 sites in 3 countries
United States14 sites, 14 recruiting
- Recruiting
Texas Oncology Arlington North
Arlington, Texas, 76012
Pre-Screener, tara.kristof@usoncology.com
- Recruiting
Texas Oncology Bedford
Bedford, Texas, 76022
Pre-Screener, tara.kristof@usoncology.com
- Recruiting
Texas Oncology Dallas Methodist
Dallas, Texas, 75203
Pre-Screener, tara.kristof@usoncology.com
- Recruiting
Texas Oncology Dallas Medical City
Dallas, Texas, 75230
Pre-Screener, tara.kristof@usoncology.com
- Recruiting
Texas Oncology Dallas Presbyterian
Dallas, Texas, 75231
Pre-Screener, tara.kristof@usoncology.com
- Recruiting
Texas Oncology Methodist Charlton Cancer Center
Dallas, Texas, 75237
Pre-Screener, tara.kristof@usoncology.com
- Recruiting
Texas Oncology-Sammons Cancer Center
Dallas, Texas, 75246
Clinical Research Coordinator II, (214)370-1942
- Recruiting
City of Hope
Duarte, California, 91010
MD, 877-467-3411
- Recruiting
Texas Oncology Fort Worth Cancer Center
Fort Worth, Texas, 76104
Pre-Screener, Alicia.Courchene@usoncology.com
- Recruiting
Texas Oncology Grapevine
Grapevine, Texas, 76051
Pre-Screener, tara.kristof@usoncology.com
- Recruiting
City of Hope at Orange County Lennar Foundation Cancer Center
Irvine, California, 92618
MD, 877-467-3411
- Recruiting
Texas Oncology Plano East
Plano, Texas, 75075
Pre-Screener, tara.kristof@usoncology.com
- Recruiting
Texas Oncology Plano West
Plano, Texas, 75093
Pre-Screener, tara.kristof@usoncology.com
- Recruiting
University of California, Los Angeles
Santa Monica, California, 90404
888-662-8252
Japan7 sites, 7 recruiting
- Recruiting
National Cancer Center Hospital
Chūōku, 104-0045
Principal Investigator
- Recruiting
Osaka International Cancer Institute
Chūōku, 541-8567
Prinicipal Investigator
Study Coordinator
- Recruiting
National Cancer Center Hospital East
Kashiwa, 277-8577
Principal Investigator
- Recruiting
The Cancer Institute Hospital of JFCR
Kōtoku, 135-8550
Site Coordinator
- Recruiting
Shizuoka Cancer Center
Nagaizumi-cho, Shizuoka, 411-8777
Principal Investigator
- Recruiting
Saitama Prefectural Hospital Organization Saitama Cancer Center
Shinden, Saitama, 362-0806
Principal Investigator
- Recruiting
Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
Yokohama, Kanagawa, 241-8515
Principal Investigator
South Korea6 sites, 6 recruiting
- Recruiting
Kyungpook National University Chilgok Hospital
Daegu, 41404
Principal Investigator
- Recruiting
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, 58128
Principal Investigator
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13605
Principal Investigator
- Recruiting
Severance Hospital
Seoul, 03722
Principal Investigator
- Recruiting
ASAN Medical Center
Seoul, 05505
Principal Investigator
- Recruiting
Samsung Medical Center
Seoul, 06351
Principal Investigator
About this study
Official title: A Randomized, Multicenter, Open-Label, Phase 2 Study of TRK-950 When Used in Combination With Ramucirumab and Paclitaxel in Patients With Gastric Cancer
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.
Read the detailed description
This study will assess and compare the efficacy, safety, pharmacokinetics (PK), optimal dose and anti-drug antibodies (ADA) and neutralizing antibodies (NAbs) development of TRK-950 at two separate dose levels in combination with RAM + PTX as compared with RAM + PTX treatment alone in participants with gastric or gastro-esophageal junction (GEJ) adenocarcinoma. The primary objective is progression free survival (PFS). Secondary objectives are overall survival, objective response rate, best overall response, duration of response, disease control rate, safety, pharmacokinetics, and immunogenicity of TRK-950 when used in combination with RAM+PTX.
- Being tested
- TRK-950, Ramucirumab, Paclitaxel
- Keywords
- Gastric Cancer, Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, TRK-950, CAPRIN-1
- Medical subject headings
- Stomach Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRK-950Biological
5 mg/kg or 10 mg/kg IV infusion over 60 minutes on Day 1, 8, 15 and 21 of each 28 day cycle
RamucirumabDrug
Also called CYRAMZA®
8 mg/kg IV infusion on Days 1 and 15 of a 28-day cycle
PaclitaxelDrug
80 mg/m^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle
| Study group | Role | What they receive |
|---|---|---|
| Arm A: TRK-950(5 mg/kg)+Ramucirumab+Paclitaxel | Experimental | Participants who will be randomized to receive a 5 mg/kg intravenous(IV) dose of TRK-950 on days 1, 8, 15 and 22 in combination with 8 mg/kg IV dose of ramucirumab on days 1 and 15 and 80 mg/m^2 IV dose of paclitaxel on Days 1, 8, and 15 of a 28-day cycle. Receives: Biological: TRK-950; Drug: Ramucirumab; Drug: Paclitaxel |
| Arm B: TRK-950(10 mg/kg)+Ramucirumab+Paclitaxel | Experimental | Participants who will be randomized to receive a 10 mg/kg intravenous(IV) dose of TRK-950 on days 1, 8, 15 and 22 in combination with 8 mg/kg IV dose of ramucirumab on days 1 and 15 and 80 mg/m^2 IV dose of paclitaxel on Days 1, 8, and 15 of a 28-day cycle. Receives: Biological: TRK-950; Drug: Ramucirumab; Drug: Paclitaxel |
| Arm C: Ramucirumab+Paclitaxel | Active comparator | Participants who will be randomized to receive a 8 mg/kg IV dose of ramucirumab on Days 1 and 15 in combination with 80 mg/m^2 IV dose of paclitaxel on Days 1, 8, and 15 of a 28-day cycle. Receives: Drug: Ramucirumab; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free Survival (PFS)
Progression free Survival (PFS) is defined as time from the date of randomization to the date of progressive disease or death due to any cause based on Independent Central Review.
Measured: Time from date of randomization to the date of progressive disease or death due to any cause, whichever occurs first, up to approximately 24 months
Secondary outcomes (27)
Overall survival (OS)
Overall survival is defined as the time from the date of randomization to the date of death due to any cause.
Measured: Time from the date of randomization to the date of death due to any cause, up to approximately 24 months
Objective response rate (ORR)
Objective response rate (ORR) is defined as the proportion of participants who achieve a best overall response of complete response (CR) or partial response (PR) using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria as assessed by Independent Central Review.
Measured: From start of treatment to date of documented disease progression, up to approximately 24 months
Progression free Survival (PFS)
Progression free Survival (PFS) is defined as time from the date of randomization to the date of progressive disease or death due to any cause based on investigator assessment.
Measured: Time from date of randomization to the date of progressive disease or death due to any cause, whichever occurs first, up to approximately 24 months
Objective response rate (ORR)
Objective response rate (ORR) is defined as the proportion of participants who achieve a best overall response of complete response (CR) or partial response (PR) using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria as assessed by investigator.
Measured: From start of treatment to date of documented disease progression, up to approximately 24 months
Best overall response (BOR)
The best overall response is defined as the best overall response (BOR) recorded from the start of treatment until the end of treatment and includes CR, PR, stable disease (SD), progressive disease (PD) and not evaluable (NE) using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria as assessed by Independent Central Review based.
Measured: From start of treatment to date of documented disease progression, up to approximately 24 months
Best overall response (BOR)
The best overall response is defined as the best overall response (BOR) recorded from the start of treatment until the end of treatment and includes CR, PR, stable disease (SD), progressive disease (PD) and not evaluable (NE) using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria as assessed by investigator.
Measured: From start of treatment to date of documented disease progression, up to approximately 24 months
Disease control rate (DCR)
Disease control rate (DCR) is defined as the proportion of participants who achieve a best overall response of complete response (CR), partial response (PR) or stable disease (SD) for a minimum of 6 weeks using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria as assessed by Independent Central Review based.
Measured: From start of treatment to date of documented disease progression, up to approximately 24 months
Disease control rate (DCR)
Disease control rate (DCR) is defined as the proportion of participants who achieve a best overall response of complete response (CR), partial response (PR) or stable disease (SD) for a minimum of 6 weeks using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria as assessed by investigator.
Measured: From start of treatment to date of documented disease progression, up to approximately 24 months
Duration of response (DoR)
Duration of response (DoR) is defined as the time from the initial response (CR or PR) until documented tumor progression or death from any cause based on Independent Central Review based.
Measured: Time from initial response (CR or PR) to date of documented disease progression or death due to any cause, whichever occurs first, up to approximately 24 months
Duration of response (DoR)
Duration of response (DoR) is defined as the time from the initial response (CR or PR) until documented tumor progression or death from any cause based on investigator assessment.
Measured: Time from initial response (CR or PR) to date of documented disease progression or death due to any cause, whichever occurs first, up to approximately 24 months
Incidence of Treatment-emergent Adverse Events (TEAE)
Adverse events will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0.
Measured: From time subjects are enrolled up to 45 days after last study dose
Serious Adverse Events (SAEs)
Adverse events will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0.
Measured: From time subjects are enrolled up to 45 days after last study dose
Adverse Events of Special Interest (AESI)
Adverse events will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0.
Measured: From time subjects are enrolled up to 45 days after last study dose
Incidence of Discontinuation due to AE
Adverse events will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0.
Measured: From time subjects are enrolled up to 45 days after last study dose
Incidence of Physical Examination Findings, Vital sign measurements, Standard clinical laboratory parameters, ECG parameters
Measured: From time subjects signs informed consent form up to 45 days after last study dose
Pharmacokinetic Parameter of Concentration of drug at the end of infusion (CEOI) of TRK-950
Measured: Cycle 1 on day 1 and 15, subsequent cycles on day 1 (each cycle is 28 days)
Pharmacokinetic Parameter of Trough Serum Concentration (Ctrough) of TRK-950
Measured: Cycle 1 on day 1 and 15, subsequent cycles on day 1 (each cycle is 28 days)
Pharmacokinetic Parameter of Area Under the Curve (AUC) of TRK-950
Measured: Cycle 1 on day 1 and 15, subsequent cycles on day 1 (each cycle is 28 days)
Pharmacokinetic Parameter of Concentration of drug at the end of infusion (CEOI) of Ramucirumab
Measured: Cycle 1 and 4 on day 1 and 15, Cycles 2, 3 and subsequent cycles on day 1 (each cycle is 28 days)
Pharmacokinetic Parameter of Trough Serum Concentration (Ctrough) of Ramucirumab
Measured: Cycle 1 and 4 on day 1 and 15, Cycles 2, 3 and subsequent cycles on day 1 (each cycle is 28 days)
Pharmacokinetic Parameter of Area Under the Curve (AUC) of Ramucirumab
Measured: Cycle 1 and 4 on day 1 and 15, Cycles 2, 3 and subsequent cycles on day 1 (each cycle is 28 days)
Pharmacokinetic Parameter of Concentration of drug at the end of infusion (CEOI) of Paclitaxel
Measured: Cycle 1 and 4 on day 1 and 15 (each cycle is 28 days)
Pharmacokinetic Parameter of Trough Serum Concentration (Ctrough) of Paclitaxel
Measured: Cycle 1 and 4 on day 1 and 15 (each cycle is 28 days)
Pharmacokinetic Parameter of Area Under the Curve (AUC) of Paclitaxel
Measured: Cycle 1 and 4 on day 1 and 15 (each cycle is 28 days)
Percentage of participants who are Anti-drug antibody (ADA)-Positive and Neutralizing antibodies (NAbs)
Measured: Cycle 1 on day 1 and 15, subsequent cycles on day 1 (each cycle is 28 days)
Change from Baseline in Patient Reported Quality of Life assessed by the Questionnaire - Core questionnaire EORTC QLQ-C30 scores
The EORTC QLQ-C30 consists of 30 questions assessing global health-related quality of life for cancer patients. It incorporates five functional scale (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), and six single-items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
Measured: From Cycle 1 on day 1 through study completion, up to approximately 24 months (each cycle is 28days)
Change from Baseline in Patient Reported Quality of Life assessed by Questionnaire - EuroQOL Five Dimensions questionnaire 3L (EQ-5D-3L) scores
The EQ-5D questionnaire consists of the following five dimensions, each describing a different aspect of health: Mobility, Self-Care, Usual Activities, Pain/Discomfort and Anxiety/ Depression. The participants self-assess each dimension has three response levels of severity: no problems, some problems, extreme problems.
Measured: From Cycle 1 on day 1 through study completion, up to approximately 24 months (each cycle is 28days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start4 Oct 2023
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Toray Industries, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06038578
- Sponsor's protocol ID
- 950GCV01
- Status last verified
- Oct 2026
- First submitted
- 29 Aug 2023
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Koyama T, Yonemori K, Sato J, Katsuya Y, Okada M, Yoshida T, Okano F, Yamamoto N. A phase I study of TRK-950, an Anti-CAPRIN-1 antibody, as monotherapy and in combination with nivolumab in Japanese patients with advanced solid tumors. Invest New Drugs. 2026 Apr 14. doi: 10.1007/s10637-026-01609-z. Online ahead of print.
PubMed 41979863
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Open-Label, Phase 2 Study of TRK-950 When Used in Combination With Ramucirumab and Paclitaxel in Patients With Gastric Cancer
- ClinicalTrials.gov ID
- NCT06038578
- Acronym / sponsor ID
- 950GCV01
- Keywords
- Gastric Cancer, Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, TRK-950, CAPRIN-1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Toray Industries, IncIndustry (pharma, biotech, devices)
- Study start
- 4 Oct 2023 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 15 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will assess and compare the efficacy, safety, pharmacokinetics (PK), optimal dose and anti-drug antibodies (ADA) and neutralizing antibodies (NAbs) development of TRK-950 at two separate dose levels in combination with RAM + PTX as compared with RAM + PTX treatment alone in participants with gastric or gastro-esophageal junction (GEJ) adenocarcinoma. The primary objective is progression free survival (PFS). Secondary objectives are overall survival, objective response rate, best overall response, duration of response, disease control rate, safety, pharmacokinetics, and immunogenicity of TRK-950 when used in combination with RAM+PTX.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A: TRK-950(5 mg/kg)+Ramucirumab+Paclitaxel | Experimental | Biological: TRK-950, Drug: Ramucirumab, Drug: PaclitaxelParticipants who will be randomized to receive a 5 mg/kg intravenous(IV) dose of TRK-950 on days 1, 8, 15 and 22 in combination with 8 mg/kg IV dose of ramucirumab on days 1 and 15 and 80 mg/m^2 IV dose of paclitaxel on Days 1, 8, and 15 of a 28-day cycle. |
| Arm B: TRK-950(10 mg/kg)+Ramucirumab+Paclitaxel | Experimental | Biological: TRK-950, Drug: Ramucirumab, Drug: PaclitaxelParticipants who will be randomized to receive a 10 mg/kg intravenous(IV) dose of TRK-950 on days 1, 8, 15 and 22 in combination with 8 mg/kg IV dose of ramucirumab on days 1 and 15 and 80 mg/m^2 IV dose of paclitaxel on Days 1, 8, and 15 of a 28-day cycle. |
| Arm C: Ramucirumab+Paclitaxel | Active comparator | Drug: Ramucirumab, Drug: PaclitaxelParticipants who will be randomized to receive a 8 mg/kg IV dose of ramucirumab on Days 1 and 15 in combination with 80 mg/m^2 IV dose of paclitaxel on Days 1, 8, and 15 of a 28-day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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 cytology) if appropriate, during or after treatment. The prior treatment must meet one of the following criteria with the following treatment history:
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRK-9505 mg/kg or 10 mg/kg IV infusion over 60 minutes on Day 1, 8, 15 and 21 of each 28 day cycle | Biological | Arm A: TRK-950(5 mg/kg)+Ramucirumab+Paclitaxel, Arm B: TRK-950(10 mg/kg)+Ramucirumab+Paclitaxel |
| RamucirumabAlso: CYRAMZA®8 mg/kg IV infusion on Days 1 and 15 of a 28-day cycle | Drug | Arm A: TRK-950(5 mg/kg)+Ramucirumab+Paclitaxel, Arm B: TRK-950(10 mg/kg)+Ramucirumab+Paclitaxel, Arm C: Ramucirumab+Paclitaxel |
| Paclitaxel80 mg/m^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle | Drug | Arm A: TRK-950(5 mg/kg)+Ramucirumab+Paclitaxel, Arm B: TRK-950(10 mg/kg)+Ramucirumab+Paclitaxel, Arm C: Ramucirumab+Paclitaxel |
Primary outcome
Progression free Survival (PFS)
Time frame: Time from date of randomization to the date of progressive disease or death due to any cause, whichever occurs first, up to approximately 24 months
Progression free Survival (PFS) is defined as time from the date of randomization to the date of progressive disease or death due to any cause based on Independent Central Review.
27 secondary outcomes
Overall survival (OS)
Time frame: Time from the date of randomization to the date of death due to any cause, up to approximately 24 months
Objective response rate (ORR)
Time frame: From start of treatment to date of documented disease progression, up to approximately 24 months
Progression free Survival (PFS)
Time frame: Time from date of randomization to the date of progressive disease or death due to any cause, whichever occurs first, up to approximately 24 months
Objective response rate (ORR)
Time frame: From start of treatment to date of documented disease progression, up to approximately 24 months
Best overall response (BOR)
Time frame: From start of treatment to date of documented disease progression, up to approximately 24 months
Best overall response (BOR)
Time frame: From start of treatment to date of documented disease progression, up to approximately 24 months
Disease control rate (DCR)
Time frame: From start of treatment to date of documented disease progression, up to approximately 24 months
Disease control rate (DCR)
Time frame: From start of treatment to date of documented disease progression, up to approximately 24 months
Duration of response (DoR)
Time frame: Time from initial response (CR or PR) to date of documented disease progression or death due to any cause, whichever occurs first, up to approximately 24 months
Duration of response (DoR)
Time frame: Time from initial response (CR or PR) to date of documented disease progression or death due to any cause, whichever occurs first, up to approximately 24 months
Incidence of Treatment-emergent Adverse Events (TEAE)
Time frame: From time subjects are enrolled up to 45 days after last study dose
Serious Adverse Events (SAEs)
Time frame: From time subjects are enrolled up to 45 days after last study dose
Adverse Events of Special Interest (AESI)
Time frame: From time subjects are enrolled up to 45 days after last study dose
Incidence of Discontinuation due to AE
Time frame: From time subjects are enrolled up to 45 days after last study dose
Incidence of Physical Examination Findings, Vital sign measurements, Standard clinical laboratory parameters, ECG parameters
Time frame: From time subjects signs informed consent form up to 45 days after last study dose
Pharmacokinetic Parameter of Concentration of drug at the end of infusion (CEOI) of TRK-950
Time frame: Cycle 1 on day 1 and 15, subsequent cycles on day 1 (each cycle is 28 days)
Pharmacokinetic Parameter of Trough Serum Concentration (Ctrough) of TRK-950
Time frame: Cycle 1 on day 1 and 15, subsequent cycles on day 1 (each cycle is 28 days)
Pharmacokinetic Parameter of Area Under the Curve (AUC) of TRK-950
Time frame: Cycle 1 on day 1 and 15, subsequent cycles on day 1 (each cycle is 28 days)
Pharmacokinetic Parameter of Concentration of drug at the end of infusion (CEOI) of Ramucirumab
Time frame: Cycle 1 and 4 on day 1 and 15, Cycles 2, 3 and subsequent cycles on day 1 (each cycle is 28 days)
Pharmacokinetic Parameter of Trough Serum Concentration (Ctrough) of Ramucirumab
Time frame: Cycle 1 and 4 on day 1 and 15, Cycles 2, 3 and subsequent cycles on day 1 (each cycle is 28 days)
Pharmacokinetic Parameter of Area Under the Curve (AUC) of Ramucirumab
Time frame: Cycle 1 and 4 on day 1 and 15, Cycles 2, 3 and subsequent cycles on day 1 (each cycle is 28 days)
Pharmacokinetic Parameter of Concentration of drug at the end of infusion (CEOI) of Paclitaxel
Time frame: Cycle 1 and 4 on day 1 and 15 (each cycle is 28 days)
Pharmacokinetic Parameter of Trough Serum Concentration (Ctrough) of Paclitaxel
Time frame: Cycle 1 and 4 on day 1 and 15 (each cycle is 28 days)
Pharmacokinetic Parameter of Area Under the Curve (AUC) of Paclitaxel
Time frame: Cycle 1 and 4 on day 1 and 15 (each cycle is 28 days)
Percentage of participants who are Anti-drug antibody (ADA)-Positive and Neutralizing antibodies (NAbs)
Time frame: Cycle 1 on day 1 and 15, subsequent cycles on day 1 (each cycle is 28 days)
Change from Baseline in Patient Reported Quality of Life assessed by the Questionnaire - Core questionnaire EORTC QLQ-C30 scores
Time frame: From Cycle 1 on day 1 through study completion, up to approximately 24 months (each cycle is 28days)
Change from Baseline in Patient Reported Quality of Life assessed by Questionnaire - EuroQOL Five Dimensions questionnaire 3L (EQ-5D-3L) scores
Time frame: From Cycle 1 on day 1 through study completion, up to approximately 24 months (each cycle is 28days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Derived from this study: PubMed 41979863Koyama T, Yonemori K, Sato J, Katsuya Y, Okada M, Yoshida T, Okano F, Yamamoto N. A phase I study of TRK-950, an Anti-CAPRIN-1 antibody, as monotherapy and in combination with nivolumab in Japanese patients with advanced solid tumors. Invest New Drugs. 2026 Apr 14. doi: 10.1007/s10637-026-01609-z. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
(Asia sites)Toray Contact for Clinical Trial Information contact
27 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TRK-950, Ramucirumab and Paclitaxel in people with Gastric Adenocarcinoma and Gastric Cancer, run by Toray Industries, Inc at 27 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, Japan, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact (Asia sites)Toray Contact for Clinical Trial Information (+81 467-32-9948, npdd-clinical.toray.mb@mail.toray), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free Survival (PFS) (time frame: Time from date of randomization to the date of progressive disease or death due to any cause, whichever occurs first, up to approximately 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06038578, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.