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

NCT06731803 - Platform Trial Evaluating Treatment of Neoadjuvant Trastuzumab-deruxtecan Containing Combination Therapies for HER2+, Resectable Esophagogastric Adenocarcinoma | Biotech Hunter | Biotech Hunter