Disitamab Vedotin Plus Trastuzumab in Patients With HER2 Positive GC/GEJ Patiens
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhejiang Cancer Hospital
About this trial
This trial is a single center, single arm, open label clinical study aimed at evaluating the efficacy and safety of the combination therapy of Disitamab Vedotin and trastuzumab in the treatment of advanced HER-2 positive gastric/gastroesophageal junction tumors
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelets ≥ 90 × 109/L, or
hemoglobin ≥ 9g/dL;
ALT or AST levels without liver metastasis are less than 2.5 times the upper limit of the normal range; When liver metastasis occurs, ALT or AST is less than 5 times the upper limit of the normal range; Serum bilirubin is 1.5 times lower than the upper limit of the normal reference range;
Serum creatinine is lower than 1.5 times the upper limit of the normal reference range or creatinine clearance rate is ≥ 40ml/min; 9. Women of childbearing age and their spouses are willing to use effective contraceptive methods within the last 7 months of treatment.
Disqualifiers
Known to be allergic to the received therapeutic drugs or excipients;
Baseline LVEF<50% (measured by echocardiography or MUGA);
Previously received treatment with anti-HER2 ADC drugs;
Individuals who have undergone systemic immunotherapy, biologic therapy, or participated in any clinical drug trials within the past 2 weeks;
Trial design
Design model
Single group
Treatments tested in this trial
Disitamab Vedotin(RC48) Plus Tratuzumab
DrugDisitamab Vedotin: 2.5mg/kg，ivgtt，D1, every 2 weeks for a treatment cycle. Tratuzumab: RP2D，ivgtt，D1, every 2 weeks for a treatment cycle.
Treatment groups
35 Participants
are divided into 1 treatment groupGroup A: Phase Ⅰ/Ⅱ： Disitamab Vedotin(RC48) Plus TratuzumabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective response rate(ORR)
he number of cases in which tumor size is reduced to PR or CR / the total number of evaluable cases (%)
Time frame
12 monthsSecondary outcomes
1
Overall survival (OS)
The time interval between the start date of study drug and the date of death (any cause)
Time frame
up to 36 months2
Progression-free survival (PFS)
Refers to the date from the date of admission to the date of the first progression of disease or death of any cause, using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Time frame
up to 12 months3
Disease control rate (DCR)
Percentage of confirmed cases including complete remission (CR), partial remission (PR) and disease stability (SD) among patients with evaluable efficacy
Time frame
up to 12 months4
Incidence of Treatment-Emergent 3/4 Adverse Events
Number and percentage of participants with Adverse Events (any Grade and Grade 3/4)
Time frame
up to 12 months after enrollment or study closeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov