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A Phase II Study to Evaluate the Efficacy and Safety of SKB571 in Recurrent or Metastatic HNSCC Participants

ConditionHNSCC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

About this trial

This is a multicenter, open-label, Phase II clinical study to assess the efficacy, safety, tolerability, PK characteristics, and immunogenicity of SKB571 in participants with recurrent or metastatic HNSCC.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 and ≤ 75 years at the time of signing the informed consent form.

Histologically or cytologically confirmed recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that is not curable by local therapy and not amenable to curative surgery, with the primary tumor located in the oral cavity, oropharynx, hypopharynx, or larynx.

Subjects with at least one measurable lesion assessed by the investigator according to RECIST v1.1.

Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 within 7 days before the first dose.

Disqualifiers

History or current metastases to central nervous system.

Subjects with other malignant tumors within 3 years prior to the first dose.

Presence of any cardiovascular and cerebrovascular disorders or risk factors.

Presence of uncontrolled systemic disease.

Trial design

Design model

Parallel

Treatments tested in this trial

  • SKB571

    Drug

    q3w

  • Pembrolizumab

    Drug

    Pembrolizumab will be administered by intravenous infusion at a dose of 200 mg on Day 1 of each 3-week cycle, for a maximum treatment duration of 35 cycles (approximately 24 months).

  • carboplatin

    Drug

    Carboplatin will be administered by intravenous infusion at a dose of AUC 5 mg/mL/min on Day 1 of each 3-week cycle (maximum dose of carboplatin not to exceed 750 mg), for a maximum of 6 cycles.

  • Cisplatin

    Drug

    Cisplatin will be administered by intravenous infusion at a dose of 75 mg/m2 on Day 1 of each 3-week cycle, for a maximum of 6 cycles.

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: Cohort 1 - SKB571 monotherapyExperimental treatment 1 intervention
Group B: Cohort 2 - SKB571 + pembrolizumab combination therapyExperimental treatment 2 interventions
Group C: Cohort 3 - SKB571 + pembrolizumab + platinum-based combination therapyExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Objective response rate (ORR) of SKB571

ORR as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Time frame
Up to approximately 24 months.

Secondary outcomes

1

Progression-free survival (PFS)

Time from start of treatment to progression of disease (PD) or death, whichever occurs first, in patients with tumors.

Time frame
Up to approximately 24 months.
2

Duration of Response (DOR)

Time from the start of the first assessment of CR or PR in tumor patients to PD or death due to any reason.

Time frame
Up to 24 months
3

Disease control rate (DCR)

Assessed by the investigators as per RECIST v1.1

Time frame
Up to 24 months
4

Overall Survival (OS)

Time from start of treatment to death due to any reason.

Time frame
Up to 24 months

Other outcomes

Sponsors and contacts

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

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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