Trials Sponsors Conditions Drugs Pricing

Conditions

Gastric Cancer Gastroesophageal Junction (GEJ) Cancer

Keywords

HER2 gastric cancer, T-Dxd, Ramucirumab

Outcome Measures

Primary Outcomes (2)

RP2D
Maximum Tolerated dose (MTD) and Recommended phase 2 dose as determined by Dose limiting Toxicity (DLT).
within first 6 weeks of treatment
PFS rate at 24 weeks
Defined as the time from start of study treatment until the date of objective disease progression or death (by any cause in the absence of disease progression) Progression is defined in accordance with the RECIST v1.1 criteria. Determination of PFS rate at 24 weeks.
within first 2 4weeks of treatment

Secondary Outcomes (6)

Overall Survival (OS)
6 months after the last treatment of the last subject
Objective Response Rate (ORR)
6 months after the last treatment of the last subject
Disease Control Rate (DCR)
6 months after the last treatment of the last subject
Duration of Response (DoR)
6 months after the last treatment of the last subject
Progression-free survival (PFS)
6 months after the last treatment of the last subject
+1 more secondary outcomes

Study Arms (1)

Single arm, Trastruzumab deruxtecan, Ramucirumab

OTHER

Single arm, Trastruzumab deruxtecan, Ramucirumab

Drug: T-Dxd(Trastuzmab deruxtecan), Ramucirumab

Interventions

T-Dxd(Trastuzmab deruxtecan), RamucirumabDrug

Phase Ib will use a standard 3+3 scheme with the planned doses of T-DXd (4.4\~6.4 mg/kg) once every 3 weeks in combination with Ramucirumab 8mg/kg administered once every 2 weeks. * Dosing Regimen * Trastruzumab deruxtecan : One IV infusion every 3 weeks on Day 1 of each 21-day cycle * Ramucirumab : One IV infusion on every 2 weeks on Day 1,15 of each 28-day cycle

Also known as: Enhertu, Cyramza

Single arm, Trastruzumab deruxtecan, Ramucirumab

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age19 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Able and willing to give written informed consent and has signed the appropriate weitten informed consent form(ICF) prior to performance of any trial activityes.
Eligible male and female subjects aged ≥19 years.

Sponsors & Collaborators

Yonsei University
Otherlead

Study Sites (1)

Sun Young Rha

Seoul, Seoul, 03722, South Korea

RECRUITING

MeSH Terms

Conditions

Stomach NeoplasmsNeoplasms

Interventions

Ramucirumab

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodies

Study Officials

SUN YOUNG RHA
Yonsei Cancer Center, Yonsei University College of Medicine
PRINCIPAL INVESTIGATOR

Central Study Contacts

SUN YOUNG RHA

CONTACT

82-2-2228-8053 rha7655@yuhs.ac

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: MD, Ph.D

Study Record Dates

First Submitted

May 31, 2023

First Posted

June 8, 2023

Study Start

February 5, 2024

Actual (reported)

Primary Completion

December 1, 2025

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

You may not qualify if:

Anticancer treatment within 14 days before the start of trial treatment.
Major surgery within 28 days before the start of trial treatment.
Have received more than 2 prior lines of chemotherapy.
Grade ≥ 2 peripheral neuropathy.
Multiple primary malignancies within 3 years.
Participants with a medical history of myocardial infarction within 6 months before treatment, symptomatic CHF (New York Heart Association Class II to IV), unstable angina pectoris, clinically important cardiac arrhythmias, or a recent (\< 6 months) cardiovascular event, including myocardial infarction, unstable angina pectoris, and stroke.
Corrected QT interval (QTcF) prolongation to \> 470 msec (females) or \>450 msec (males) based on an average of the screening triplicate 12-lead ECG.
Gastrointestinal perforation or fistula or any Grade 3-4 bleeding within 3 months of first dose of protocol therapy; or any arterial thromboembolic event, significant gastro-intestinal bleeding or any significant venous thromboembolism within 3 months before treatment
History of (non-infectious) ILD / pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
Lung criteria: A. Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder. B. Any autoimmune, connective tissue or inflammatory disorders C. Prior pneumonectomy
Has known active CNS metastases and/or carcinomatous meningitis.
Has substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions that may, in the opinion of the investigator, interfere with the subject's participation in the clinical study or evaluation of the clinical study results.
Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.
Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.
Active primary immunodeficiency, known uncontrolled active HIV infection or active hepatitis B or C infection, such as those with serologic evidence of viral infection within 28 days of Cycle 1 Day 1. 16. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. 17. Receipt of live, attenuated vaccine (mRNA and replication deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first dose of trastuzumab deruxtecan. Note: Patients, if enrolled, should not receive live vaccine during the study and up to 30 days after the last dose of IMP. 18. Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤ 1 or baseline. 19. Known allergy or hypersensitivity to study treatment or any of the study drug excipients.
+7 more criteria

T-Dxd in Combination With Ramucirumab as HER2 Low Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (6)

Study Arms (1)

Single arm, Trastruzumab deruxtecan, Ramucirumab

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (6)

Study Arms (1)

Single arm, Trastruzumab deruxtecan, Ramucirumab

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations