NCT06572319

Disitamab Vedotin Plus Trastuzumab in Patients With HER2 Positive GC/GEJ Patiens

Phase I/II Clinical Study of the Combination of Disitamab Vedotin and Trastuzumab in the Treatment of HER2 Positive Gastric/Gastroesophageal Junction Tumors With Previous Systemic Therapy Failure

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 gastric/gastroesophageal 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 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.

Conditions

• HER2-positive Gastric Cancer
• HER2-positive Gastroesophageal Junction Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Disitamab Vedotin(RC48) Plus Tratuzumab	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.

Timeline

• Start date: 2024-09-01
• Primary completion: 2026-08-01
• Completion: 2026-12-31
• First posted: 2024-08-27
• Last updated: 2024-08-27

Locations

1 site across 1 country: China