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Clinical Trial of SIBP-03 in Patients With Head and Neck Squamous Cell Carcinoma

ConditionHead and Neck Squamous Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Institute Of Biological Products

About this trial

This phase II study will be conducted in two parts (Ⅱa and Ⅱb), with a 21-day treatment cycle until disease progression, intolerable toxicity, withdrawal of informed consent, death, initiation of new anti-tumor treatment or loss of follow-up.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The subjects voluntarily participated in the study and signed the informed consent.

Male and female aged between 18 and 75 years old, regardless of gender.

Patients with recurrent/metastatic advanced HNSCC who have been diagnosed by histology or cytology, progressed or intolerant after previous immunotherapy containing anti-PD-1/anti-PD-L1 and platinum, and have no indication of radical local treatment. Subjects should not receive more than 2 lines of treatment in the past.

During the screening period, subjects must provide tumor tissues and blood samples for biomarker detection. If the subject does not have an archived tumor tissue sample, he or she will undergo a fresh tumor biopsy during the screening period to obtain the corresponding tumor sample. If the subject can't provide archived or fresh tumor tissue samples, but can provide the previous test reports of qualified institutions, including all biomarker indicators specified in this scheme, they can be screened after communicating with the sponsor.

Disqualifiers

The primary site of squamous cell carcinoma is nasal cavity, paranasal sinuses, nasopharynx and salivary gland.

The participant has received any HER3 targeting or EGFR targeting therapy in the past.

Active central nervous system metastasis and/or meningeal metastasis.

Previous allergy to human normal immunoglobulin or antibody preparation or other serious infusion reaction; Severe hypersensitivity disease, allergic constitution.

Trial design

Design model

Parallel

Treatments tested in this trial

  • HER3 Monoclonal antibodies-Dose A

    Drug

    Dose A, intravenous infusion (IV), once every three weeks, 21 days as a cycle. The infusion time is 90 min (± 5 min).

  • HER3 Monoclonal antibodies-Dose B

    Drug

    Dose B, intravenous infusion (IV), once every three weeks, 21 days as a cycle. The infusion time is 90 min (± 5 min).

  • HER3 Monoclonal antibodies-Dose C

    Drug

    Dose C, intravenous infusion (IV), once every three weeks, 21 days as a cycle. The infusion time is 90 min (± 5 min).

  • HER3 Monoclonal antibodies-Dose D

    Other intervention

    The optimal recommended dosage (RP2D) of SIBP-03intravenous, infusion (IV), once every three weeks, 21 days as a cycle. The infusion time is 90 min (± 5 min).

  • Placebo

    Other intervention

    SIBP-03 solvent without HER3 antibody, intravenous infusion (IV), once every one weeks, 21 days as a cycle.

  • Cetuximab injection

    Combination product

    Medications used for combination therapy, intravenous infusion (IV). Administer once a week.

Treatment groups

81 Participants
are divided into 5 treatment groups
Group A: Group AExperimental treatment 2 interventions
Group B: Group BExperimental treatment 2 interventions
Group C: Group CExperimental treatment 2 interventions
Group D: Group DExperimental treatment 2 interventions
Group E: Group EPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

The occurrence of any adverse events (AE)

All subjects after receiving the investigational drug were observed during the trial for any AE that occurred during the clinical study.AE were manifested as symptoms, signs, diseases, or abnormal laboratory tests, but may not necessarily have a causal relationship with the investigational drug.

Time frame
30 days after the last dose
2

SAE (Serious Adverse Events)

That is serious adverse events, any serious adverse events that occurred to the subject during the study period.

Time frame
30 days after the last dose
3

Cmax (Peak Plasma Concentration)

It shows the highest plasma concentration of a drug that can be achieved after administration.

Time frame
30 days after the last dose
4

Tmax(Peak Time)

That is peak time of drug action, it shows the time required to reach the maximum concentration on the subject plasma concentration curve after administration.

Time frame
30 days after the last dose

Secondary outcomes

1

ORR (Objective Response Rate)

The proportion of subjects whose tumor volume shrinks to a predetermined value and maintains the minimum time limit, and is the sum of complete and partial responses.

Time frame
The 1 day the test results reported after the last dose
2

DCR (Disease control rate)

In clinical trials, the percentage of subjects with advanced or metastatic cancer who responded fully to cancer treatment, partially responded, and had stable disease.

Time frame
The 1 day the test results reported after the last dose
3

PFS (Progression-free survival)

The time between the onset of randomization and the onset (of any aspect) of tumor progression or death (from any cause).

Time frame
The 1 day the test results reported after the last dose
4

ADA (Anti-drug Antibody)

The incidence of anti-drug antibody.

Time frame
The 1 day the test results reported after the last dose

Other outcomes

Sponsors and contacts

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

Shanghai Institute Of Biological Products

Lead sponsor

Source ClinicalTrials.gov
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