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Pucotenlimab Plus Becotatug Vedotin in Perioperative Treatment of Locally Advanced Resectable Head and Neck Squamous Cell Carcinoma

ConditionHead and Neck Squamous Cell Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorLepu Biopharma Co., Ltd.

About this trial

A multicenter, randomized, double-blind, phase II clinical study designed to evaluate the safety, pharmacokinetics, and preliminary efficacy of Becotatug Vedotin for Injection in combination with PD-1 in patients with locally advanced resectable head and neck squamous cell carcinoma

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Life expectancy ≥ 6 months.

Subjects with histologically confirmed, resectable Stage III-IVA head and neck squamous cell carcinoma (HNSCC) eligible for curative-intent surgery.

At least one extracranial measurable lesion per RECIST v1.1.

Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

Disqualifiers

Primary tumor originating from nasopharynx, nasal cavity, paranasal sinuses, salivary gland, thyroid/parathyroid gland, skin, or unknown primary site (squamous cell carcinoma).

Head and neck cancer deemed non-resectable by the investigator.

Prior treatment with anti-PD-1, anti-PD-L1, MMAE/MMAF-based ADC agents, or other T-cell immune checkpoint inhibitors.

Prior radiotherapy, systemic anti-tumor therapy, or other investigational therapy for head and neck cancer before study entry.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Becotatug Vedotin for Injection

    Drug

    Administrated intravenously

  • Placebo

    Drug

    Administrated intravenously

  • Pucotenlimab Injection

    Drug

    Administrated intravenously

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: locally advanced resectable HNSCC Becotatug Vedotin +PucotenlimabExperimental treatment 2 interventions
Group B: locally advanced resectable HNSCC Placebo +PucotenlimabPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Major Pathological Response (MPR) Rate

Time frame
From date of surgery until completion of postoperative pathological assessment, up to 8 weeks

Secondary outcomes

1

Pathological Complete Response (pCR) Rate

Time frame
From date of surgery until completion of postoperative pathological assessment, up to 8 weeks
2

Event-Free Survival (EFS)

Time frame
From date of randomization until the date of disease progression/recurrence with initiation of new anti-tumor therapy, or death from any cause, whichever came first, assessed up to 24 months
3

Overall Survival (OS)

Time frame
From date of randomization until death from any cause, assessed up to 36 months
4

Preoperative Objective Response Rate (ORR)

Time frame
preoperative ORR will be assessed up to 12 weeks post-randomization

Other outcomes

Sponsors and contacts

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

Lepu Biopharma Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

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