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

NCT05898373 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-06-12

No results posted yet for this study

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.

Conditions

  • Salivary Gland Cancer

Interventions

DRUG

vedicitumomab (Edisil, RC48）

intravenously for 6-8 cycles before surgery and postoperative radiotherapy, followed by Treatment with injectable recombinant humanized anti-HER2 monoclonal antibody-MMAE coupling agent vedicitumomab (Edisil, RC48) until 1 year or disease progression or intolerable toxicity in locally advanced patients , and until disease progression or intolerable toxicity in metastatic patients .

DRUG

vedicitumomab in combination with pyrrolizidine

vedicitumomab in combination with pyrrolizidine

DRUG

RC48 in combination with a platinum-based chemotherapeutic agent

RC48 in combination with a platinum-based chemotherapeutic agent

DRUG

RC48 in combination with teraplizumab

RC48 in combination with teraplizumab

Sponsors & Collaborators

  • Peking Union Medical College

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-07
Primary Completion
2025-06-06
Completion
2026-06-06

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05898373 on ClinicalTrials.gov