Platform Trial Evaluating Treatment of Neoadjuvant Trastuzumab-deruxtecan Containing Combination Therapies for HER2+, Resectable Esophagogastric Adenocarcinoma

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

March 25, 2025

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2027

Conditions
Esophagogastric Adenocarcinoma
Interventions
DRUG

Trastuzumab deruxtecan + 5FU/LV

trastuzumab deruxtecan 5.4 mg/kg i.v., on day 1, Q3W for max 3 cycles plus 4 cycles 5-FU/LV: leucovorin 200 mg/m2 i.v., followed by 5-fluorouracil (5-FU) 2600 mg/m2 as a 24-h continuous infusion on day 1, Q2W for 4 cycles

DRUG

Trastuzumab deruxtecan + FLO

trastuzumab deruxtecan 5.4 mg/kg i.v., on day 1, Q3W for max 3 cycles plus 4 cycles FLO: oxaliplatin 85 mg/m2 and leucovorin 200 mg/m2, each as an i.v. infusion followed by 5-FU 2600 mg/ m2 as a 24-h continuous infusion on day 1, Q2W for 4 cycles

Trial Locations (11)

13353

NOT_YET_RECRUITING

Charite Universitätsmedizin Berlin, Berlin

20249

NOT_YET_RECRUITING

Hämatologisch-Onkologische Praxis Eppendorf (hope), Hamburg

60488

NOT_YET_RECRUITING

Krankenhaus Nordwest GmbH Institut für Klinisch-Onkologische Forschung (IKF), Frankfurt am Main

69120

NOT_YET_RECRUITING

Nationales Centrum für Tumorerkrankungen, Heidelberg

81675

NOT_YET_RECRUITING

Klinikum rechts der Isar München der TU München, München

89081

NOT_YET_RECRUITING

Universitätsklinikum Ulm, Ulm

90419

NOT_YET_RECRUITING

Klinikum Nürnberg, Nuremberg

09116

NOT_YET_RECRUITING

Klinikum Chemnitz gGmbH, Chemnitz

06120

NOT_YET_RECRUITING

Universitätsmedizin Halle, Universitätsklinikum Halle (Saale), Halle

07747

NOT_YET_RECRUITING

Universitätsklinikum Jena, Jena

04103

RECRUITING

Universitätsklinikum Leipzig, Leipzig

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Daiichi Sankyo

INDUSTRY

lead

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

OTHER