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

ConditionSalivary Gland Cancer
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking Union Medical College

About this trial

(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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Crossover

Treatments tested in this trial

  • vedicitumomab (Edisil, RC48）

    Drug

    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 .

  • vedicitumomab in combination with pyrrolizidine

    Drug

    vedicitumomab in combination with pyrrolizidine

  • RC48 in combination with a platinum-based chemotherapeutic agent

    Drug

    RC48 in combination with a platinum-based chemotherapeutic agent

  • RC48 in combination with teraplizumab

    Drug

    RC48 in combination with teraplizumab

Treatment groups

120 Participants
are divided into 4 treatment groups
Group A: vedicitumomabExperimental treatment 1 intervention
Group B: vedicitumomab in combination with pyrrolizidineExperimental treatment 1 intervention
Group C: RC48 in combination with a platinum-based chemotherapeutic agentExperimental treatment 1 intervention
Group D: RC48 in combination with teraplizumabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

ORR

ORR definition: the proportion of patients with tumor volume reduction to pre-specified values (CR/PR) who can maintain the minimum time requirement

Time frame
8 weeks

Secondary outcomes

1

PFS

PFS definition: the time from the start of randomization (or the start of treatment in a single-arm trial) to tumor progression or death from any cause, whichever occurs first;

Time frame
2 years
2

DFS

disease-free survival (DFS) definition: is the time from the start of randomization (or the start of treatment in a single-arm trial) to disease recurrence or death from any cause (whichever occurs first)

Time frame
2 years
3

OS

OS defined as means the time from the start of randomization (or the start of treatment in a single-arm trial) to death from any cause

Time frame
2 years
4

complete resection rate

complete resection rate: lesion R0 resection and no extraperitoneal invasion of lymph nodes, no positive lymph on residual

Time frame
2 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking Union Medical College

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: