Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06572319
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
Disitamab Vedotin Plus Trastuzumab in Patients With HER2 Positive GCGEJ Patiens
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase III Clinical Study of the Combination of Disitamab Vedotin and Trastuzumab in the Treatment of HER2 Positive GastricGastroesophageal Junction Tumors With Previous Systemic Therapy Failure
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 gastricgastroesophageal junction tumors
Detailed Description:
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 drugs 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 III clinical trial to explore whether the combination of RC48 and naked anti trastuzumab currently on the market can improve efficacy
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 III clinical trial to explore whether the combination of RC48 and naked anti trastuzumab currently on the market can improve efficacy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None