Health TrialsbyHealthPanel

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

ConditionHead and Neck Squamous Cell Carcinoma
Trial statusRecruiting
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
Apply now