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

Sponsor
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Study ID
NCT06731803
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Esophagogastric Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Trastuzumab deruxtecan + 5FU/LV — DRUG
    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
  • Trastuzumab deruxtecan + FLO — DRUG
    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

Study Details

The study is a phase Ib/II, prospective, single arm, open label, non-randomized, multi-center platform trial assessing the feasibility and safety of different neoadjuvant trastuzumab-deruxtecan containing combinational treatment regimens in patients with HER2 positive, locally advanced, resectable esophagogastric adenocarcinoma

Key Dates

Start date
Mar 25, 2025
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
36 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: NeoART-001
    Trastuzumab-deruxtecan 5.4 mg/kg i.v., on day 1, Q3W plus 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. Patients will receive three cycles of neoadjuvant T-DXd combined with four cycles 5-FU/LV followed by surgery.
  • Experimental: NeoART-002
    Trastuzumab-deruxtecan 5.4 mg/kg i.v., on day 1, Q3W plus FLO: oxaliplatin 85 mg/m2 \& 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. Patients will receive three cycles of neoadjuvant T-DXd combined with four cycles 5-FU/LV followed by surgery.

Primary Outcome Measure

Feasibility rate [ Time Frame: 9 weeks ]

Related Studies