Becotatug Vedotin Plus PD-1 Monoclonal Antibody and Radiotherapy for Unresectable Locally Recurrent Nasopharyngeal Carcinoma

Sponsor
Sun Yat-sen University
Study ID
NCT07555860
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Nasopharyngeal Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Becotatug Vedotin — DRUG
    Becotatug vedotin will be administered at 2.0 mg/kg intravenously on Day 1 every 3 weeks for 2 cycles as induction therapy, in combination with a PD-1 monoclonal antibody.
  • Toripalimab — DRUG
    Toripalimab will be administered at 240 mg intravenously on Day 1 every 3 weeks. Toripalimab is one of the optional PD-1 monoclonal antibodies in this study and will be used as an alternative to camrelizumab, not in combination with camrelizumab. It will be given during induction therapy, concurrently with radiotherapy, and as maintenance therapy after radiotherapy until disease progression or unacceptable toxicity.
  • Camrelizumab — DRUG
    Camrelizumab will be administered at 200 mg intravenously on Day 1 every 3 weeks. Camrelizumab is one of the optional PD-1 monoclonal antibodies in this study and will be used as an alternative to toripalimab, not in combination with toripalimab. It will be given during induction therapy, concurrently with radiotherapy, and as maintenance therapy after radiotherapy until disease progression or unacceptable toxicity.
  • Intensity-Modulated Radiotherapy — DRUG
    Intensity-modulated radiotherapy will be delivered once daily, 5 days per week. Prescribed doses are 60 Gy in 27 fractions to PTVnx, 60-64 Gy in 27 fractions to PTVnd, and 54 Gy in 27 fractions to PTV1.

Study Details

This exploratory clinical study will enroll patients with unresectable locally recurrent nasopharyngeal carcinoma to receive two cycles of becotatug vedotin plus a PD-1 monoclonal antibody, followed by sequential radiotherapy and PD-1 monoclonal antibody maintenance until disease progression or unacceptable toxicity. The study aims to evaluate the efficacy and safety of this treatment strategy.

Key Dates

Start date
Apr 20, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2029

Study Design

Enrollment
28 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental group
    Becotatug Vedotin Plus PD-1 Monoclonal Antibody Induction Followed by Radiotherapy With Concurrent and Maintenance PD-1 Monoclonal Antibody

Primary Outcome Measure

Objective response rate [ Time Frame: Baseline; end of 2 induction cycles (21 days/cycle); 8-12 weeks after radiotherapy; every 12 weeks through Month 24; then every 24 weeks thereafter until progression, new anticancer therapy, death, or study completion, up to 36months. ]

Central Contacts

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