Developing ctDNA Guided Adjuvant Therapy for Gastrooesophageal Cancer

Sponsor
University of Southampton
Study ID
NCT05965479
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Gastrooesophageal Cancer

Eligibility Criteria

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

Interventions

  • Trastuzumab deruxtecan — DRUG
    Trastuzumab deruxtecan is an antibody-drug conjugate that contains trastuzumab covalently linked to deruxtecan, a topoisomerase I inhibitor. It is given by intravenous infusion.

Study Details

Multicentre, single arm, open label UK phase II trial to assess the efficacy of trastuzumab deruxtecan in reducing micrometastatic disease burden in HER2 positive GOA patients who are ctDNA positive after chemotherapy and surgery. 25 patients will be recruited from approximately 15 NHS secondary care sites.

Key Dates

Start date
Apr 10, 2024
Status verified
Nov 2024
Primary completion
Mar 31, 2026
Completion
Apr 30, 2028

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Trastuzumab deruxtecan
    Participants in the study will be treated with trastuzumab deruxtecan at a dose of 6.4 mg/kg intravenously every 21 days for 8 cycles. If required, patients may dose reduce to level -1 or level -2: * Dose level 0 is 6.4 mg/kg intravenously every 21 days * Dose level -1 is 5.4 mg/kg intravenously every 21 days * Dose level -2 is 4.4 mg/kg intravenously every 21 days T-DXd will be administered using an IV bag containing 5% (w/v) Dextrose Injection infusion solution and delivered through an IV administration set with a 0.2 or 0.22 μm filter. The standard infusion time for T-DXd is approximately 90 minutes +/- 10 minutes for the first infusion. If the first infusion is well tolerated and the participant does not experience an infusion-related reaction, then the minimum infusion time for subsequent cycles is 30 minutes. However, if there are interruptions during the infusion, the total time must not exceed 3 hours at room temperature.

Primary Outcome Measure

ctDNA clearance [ Time Frame: At the end of Cycle 4 (each cycle is 21 days) ]

Central Contacts