Vedicitumomab Alone or in Combination for the Treatment of Locally Advanced or Metastatic SDC

Salivary Gland Cancer Clinical Trial

Official title: Phase II, Multi-arm, Open Clinical Study of Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Coupling Agent Vedicitumomab Alone or in Combination for the Treatment of Locally Advanced or Metastatic Salivary Gland Ductal Carcinoma

Status Not yet recruiting

Clinical Trial Summary

(1) To apply Bayesian statistics to screen for the most effective treatment regimen containing recombinant humanized anti-HER2 monoclonal antibody-MMAE coupling agent vedicitumomab (Edisil, RC48) for locally advanced or metastatic salivary gland ductal carcinoma expressing HER2 in the near future. (2) To explore biomarkers relevant to the efficacy of recombinant humanized anti-HER2 monoclonal antibody-MMAE-coupled vedicitumomab (Edisil, RC48) in the treatment of HER2-expressing locally advanced or metastatic salivary gland ductal carcinoma.

Clinical Trial Description

Using a Bayesian adaptation method based on posterior probabilities, patients will be randomized into four cohorts as follows:

(i) Cohort 1 (RC48 monotherapy group, control group): vedicitumomab monotherapy (2.5 mg/kg, intravenous, Q2w); (ii) Cohort 2 (RC48 + pyrrolitinib group): vedicitumomab (Edexcel, RC48) (2 mg/kg, sedation, Q2w) combined with an oral HER2 TKI (pyrrolitinib 400 mg po qd ); (iii) Cohort 3 (RC48 + platinum group): vedicitumomab (2mg/kg, IV, Q2w) in combination with a physician's choice of platinum-based chemotherapy (carboplatin 200-250mg/m2, IV, Q2w or cisplatin 50mg/m2, IV, Q2w); (iv) Cohort 4 (RC48 + Tremelimumab group): vedicitumomab (2mg/kg, IV, Q2w) in combination with the immune checkpoint inhibitor tremelimumab (3mg/kg, IV, Q2w);

In this study, we will detect HER2 immunohistochemistry, HER2FISH (HER2/CEP17), androgen receptor AR, value-added index ki67, human epidermal growth factor EGFR, basal cytokeratin CK5/6, immune checkpoint PD-L1, type 4 mucin MUC4, recombinant human RAS-related protein, etc. in pre-treatment specimens using traditional immunohistochemistry methods. 5ARAB5A, tumor infiltrating lymphocytes TILs, regulatory T cells Treg and other immune cells, circulating tumor cell DNA (ctDNA) by NGS, blood count, lymphocyte subsets, and HER2 ECD by ELISA. Patients with locally advanced disease were divided into pCR group (complete remission group) and non-pCR group (non-complete remission group) according to their clinical response to treatment, and patients with advanced metastatic disease were divided into PD group (disease progression group) and non-PD group (non-progression group), comparing the differences between the pCR and non-pCR groups, and the differences between the PD and non-PD groups, and exploring the differences with vedicizumab (Edisil, RC48) in monotherapy or combination for salivary gland ductal carcinoma. ;

Related Conditions & MeSH terms

• Salivary Gland Cancer
• Salivary Gland Neoplasms

• NCT number: NCT05898373
• Study type: Interventional
• Source: Peking Union Medical College
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: June 7, 2023
• Completion date: June 6, 2026