Finotonlimab Combined With Stapokibart in the Treatment of Recurrent/Metastatic HNSCC
ConditionHNSCC
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing Tongren Hospital
About this trial
This is a single-arm, phase Ib study involving HNSCC patients who had received first-line treatment with either PD-1 combined with platinum-based drugs or PD-1 monotherapy. The aim of the study is to evaluate the safety and efficacy of Finotonlimab in combination with Stapokibart in the treatment of recurrent/metastatic HNSCC patients.
Eligibility criteria
Qualifiers
Voluntarily sign the ICF;
Recurrent/metastatic HNSCC of the oral cavity, oropharyngeal, pharyngeal, and laryngeal regions;
Male/female, ≥ 18 years old, ECOG 0~1;
After PD-1 and platinum therapy, or PD-1 monotherapy, disease progression occurs within 24 weeks after the last ICI administration (as assessed by RECIST 1.1);
Disqualifiers
Suitable for local treatment;
Merge with other malignant tumors;
Brain metastasis;
If the toxicity does not recover to level 0-1 after surgery/radiotherapy/drug treatment, excluding chronic toxicity;
Trial design
Treatments tested in this trial
- Stapokibart and Finotonlimab
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Beijing Tongren Hospital
Lead sponsor
Sinocelltech Ltd.
Collaborator
Keymed Biosciences Co.Ltd
Collaborator
Source ClinicalTrials.gov