A Prospective, Single-arm, Phase II Clinical Trial of Becotatug Vedotin for Injection Combined With Pucotenlimab Injection as a First-line Treatment for Platinum-intolerant Advanced Head and Neck Squamous Cell Carcinoma

ConditionHNPCC
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age70-105
SponsorCancer Hospital Chinese Academy of Medical Science, Shenzhen Center

About this trial

This study is a randomized, open-label, multi-center phase II trial evaluating the efficacy and safety of the becotatug vedotin in combination with pucotenlimab regimen in patients with advanced head and neck squamous cell carcinoma who are intolerant to platinum-based therapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically or cytologically diagnosed as squamous cell carcinoma, with the lesion site located in the oral cavity, oropharynx, hypopharynx, larynx, etc.;

Recurrence and metastasis occurred after previous local treatment (surgery, radiotherapy, or concurrent chemoradiotherapy), with no possibility of cure, and no systemic treatment had been received previously, or previous induction or adjuvant treatment had been received, but the time from the end of the above treatment was ≥ 6 months;

Existence of distant metastasis at the time of initial treatment, or extensive local lesion range, and not curable after MDT assessment;

Patients who cannot tolerate platinum-based chemotherapy or do not accept cisplatin-based chemotherapy; Definition of cisplatin intolerance: Any of the following criteria met: age ≥ 70 years; mild or above hearing impairment; creatinine clearance rate < 50 ml/min (calculated according to the Cockcroft and Gault formula);

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Becotatug Vedotin (recombinant humanized anti-EGFR mAb-MMAE conjugate) combined with Pucotenlimab (recombinant humanized anti-PD-1 mAb)

    Drug

    Becotatug Vedotin for Injection combined with Pucotenlimab Injection as first-line treatment

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Treatment ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective Response Rate

Time frame
Up to 24 months from the first dose
2

ORR

Time frame
up to 24 months from the first dose

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center

Lead sponsor

Affiliated Cancer Hospital of Shantou University Medical College

Collaborator

The University of HongKong-Shenzhen Hospital

Collaborator

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