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
In a specific tumor area, the absorption of antibodies is driven by its blood vessels or permeable surface, while the microscopic distribution depends on the number of binding sites available for the specific antibody. Due to the much faster binding rate of antibodies to their targets than their diffusion rate, their penetration into tumor tissue is severely limited (such as binding site barriers). This will limit the drug's penetration into the tumor before the antibody reaches saturation dose. Due to the toxicity brought by the toxins carried by ADC itself (toxin shedding, non-specific endocytosis, or on target, off tumor toxicity), its dose will be relatively reduced compared to naked antibodies. By adding naked antibodies or directly reducing DAR, the dose of ADC can be increased to overcome the binding site barrier and improve the tumor penetration of antibody drugs. In theory, if the antibody dose is large enough, the antibody will reach all (accessible) binding points within the tumor and saturate both the interior and periphery of the tumor. In addition, in addition to ADC drugs, chemotherapy, immunotherapy, targeted therapy, and other options are also available for HER2 positive gastric cancer posterior line, but the efficacy is still unclear. Therefore, it is urgent to explore new treatment options to further improve the efficacy of this special population. Therefore, we designed this Phase I/II clinical trial to explore whether the combination of RC48 and naked anti trastuzumab currently on the market can improve efficacy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Disitamab Vedotin: 2.5mg/kg,ivgtt,D1, every 2 weeks for a treatment cycle. Tratuzumab: RP2D,ivgtt,D1, every 2 weeks for a treatment cycle.
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
RECRUITINGObjective 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 months
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 months
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 months
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 months
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 close
Jieer Ying, M.D.
CONTACT
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