Spots Global Cancer Trial Database for Tusamitamab Ravtansine (SAR408701) in Combination With Ramucirumab in Pretreated Participants With Gastric Cancer
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Trial Identification
Brief Title: Tusamitamab Ravtansine (SAR408701) in Combination With Ramucirumab in Pretreated Participants With Gastric Cancer
Official Title: Open-label Study of Tusamitamab Ravtansine (SAR408701) in Combination With Ramucirumab in Participants Previously Treated for Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma With CEACAM5-positive Tumors
Study ID: NCT05071053
Study Description
Brief Summary: Primary Objectives: Part 1: to confirm the recommended tusamitamab ravtansine loading dose Q2W in combination with ramucirumab in advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma population Part 2: to assess the antitumor activity of tusamitamab ravtansine loading dose Q2W in combination with ramucirumab in advanced gastric or GEJ adenocarcinoma Secondary Objectives: * To assess safety * To assess durability * To assess progression-free survival (PFS) * To assess the disease control rate (DCR) * To assess the pharmacokinetics (PK) * To assess the immunogenicity
Detailed Description: 34 weeks (up to 4 weeks for screening, a median of 18 weeks for treatment, and a median of 12 weeks for end-of-treatment assessments and the safety follow-up visit).
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Investigational Site Number : 0560002, Bruxelles, , Belgium
Investigational Site Number : 0560003, Edegem, , Belgium
Investigational Site Number : 0560001, Leuven, , Belgium
Investigational Site Number : 3920002, Kashiwa-shi, Chiba, Japan
Investigational Site Number : 3920004, Matsuyama-shi, Ehime, Japan
Investigational Site Number : 3920001, Sapporo-shi, Hokkaido, Japan
Investigational Site Number : 3920003, Sunto-gun, Shizuoka, Japan
Investigational Site Number : 4100002, Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 4100003, Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 4100001, Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 4100004, Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 6430003, Pushkin, Saint- Petersburg, Saint- Petersburg, Russian Federation
Investigational Site Number : 6430001, Arkhangelsk, , Russian Federation
Investigational Site Number : 7240002, Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240003, Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240004, Granada, , Spain
Investigational Site Number : 7240001, Madrid, , Spain
Investigational Site Number : 7920003, Ankara, , Turkey
Investigational Site Number : 7920001, Istanbul, , Turkey
Investigational Site Number : 7920002, Istanbul, , Turkey
Investigational Site Number : 7920004, Malatya, , Turkey
Contact Details
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