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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Stapokibart and Finotonlimab
Combination productReceive the combination therapy with Stapokibart and Finotonlimab. Stapokibart, 600mg for the first cycle, 300mg for the second and subsequent cycles, administered subcutaneously every 3 weeks; Finotonlimab 200mg, administered intravenously every 3 weeks. Treatment with Stapokibart in combination with Finotonlimab was continued until confirmed disease progression occurs according to the RECIST 1.1 imaging criteria (if the researcher determines that the subject can benefit from continuing PD-1 drug treatment, and the subject can tolerate the study treatment and agree, PD-1 drug can be continued and recorded in the study records), unacceptable toxic side effects, initiation of new anti-tumor treatment, withdrawal from the study or death (whichever occurs first), or reaching a maximum treatment period of 2 years.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Stapokibart and FinotonlimabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Adverse events (AEs)
Number of participants with AEs assessed by Common Terminology Criteria for Adverse Events v5.0.
Time frame
Up to 2 years2
Overall response rate (ORR)
Percentage of participants with a confirmed best overall complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors version 1.1 (RECIST 1.1).
Time frame
Up to 2 yearsSecondary outcomes
1
Disease control rate (DCR)
The proportion of participants who achieve complete response (CR), partial response (PR), or stable disease (SD) as their best overall response, according to RECIST 1.1 criteria.
Time frame
Up to 2 years2
Progression free survival (PFS)
PFS will be calculated from the first administration of Stapokibart to the date of documented disease progression, or death from any cause.
Time frame
Up to 2 years3
Duration of response (DOR)
The time from the date of first response (CR or PR) to the date of progression of disease or death of any cause.
Time frame
Up to 2 yearsOther outcomes
1
Histopathological evaluation of tumor tissues
Mean change from baseline in the proportions (%) of Ki67-, p63-, and EGFR-positive cells in tumor tissue, assessed by immunohistochemistry, before and after treatment with Stapokibart and Finotonlimab.
Time frame
Up to 10 weeks2
Change in proportions of tumor-infiltrating immune cell subtypes
Mean change from baseline in the proportion (%) of tumor-infiltrating immune cells, including T cells, B cells, natural killer cells, dendritic cells, macrophages, and mast cells, in tumor tissue following treatment.
Time frame
up to 10 weeks3
Change in serum cytokine concentrations from baseline to Week 10
Mean change from baseline in serum concentrations of IL-4, IL-13, IFN-γ, IL-17A, IL-8, IL-10 and other exploratory cytokines following treatment.
Time frame
up to 10 weeks4
Change in peripheral immune cell subtypes and activation status
Mean change from baseline in the proportion (%) and activation status of peripheral immune cell subsets, including T cells, B cells, natural killer cells, dendritic cells and monocytes, assessed by flow cytometry following treatment.
Time frame
up to 10 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Beijing Tongren Hospital
Lead sponsor
Sinocelltech Ltd.
Collaborator
Keymed Biosciences Co.Ltd
Collaborator
Source ClinicalTrials.gov