A Randomized, Multicenter, Open-Label, Phase 2 Study of TRK-950 When Used in Combination With Ramucirumab and Paclitaxel in Patients With Gastric Cancer
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.
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.
Arms & interventions
- BiologicalTRK-950
5 mg/kg or 10 mg/kg IV infusion over 60 minutes on Day 1, 8, 15 and 21 of each 28 day cycle
- DrugRamucirumab
8 mg/kg IV infusion on Days 1 and 15 of a 28-day cycle
- DrugPaclitaxel
80 mg/m\^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle
Outcome measures
Primary
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.
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
Secondary
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)
Eligibility criteria
Study locations (14)
City of Hope
Duarte, California, 91010
City of Hope at Orange County Lennar Foundation Cancer Center
Irvine, California, 92618
University of California, Los Angeles
Santa Monica, California, 90404
Texas Oncology Arlington North
Arlington, Texas, 76012
Texas Oncology Bedford
Bedford, Texas, 76022
Texas Oncology Dallas Methodist
Dallas, Texas, 75203
Texas Oncology Dallas Medical City
Dallas, Texas, 75230
Texas Oncology Dallas Presbyterian
Dallas, Texas, 75231
Texas Oncology Methodist Charlton Cancer Center
Dallas, Texas, 75237
Texas Oncology-Sammons Cancer Center
Dallas, Texas, 75246
Texas Oncology Fort Worth Cancer Center
Fort Worth, Texas, 76104
Texas Oncology Grapevine
Grapevine, Texas, 76051
Texas Oncology Plano East
Plano, Texas, 75075
Texas Oncology Plano West
Plano, Texas, 75093
References
- 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)