Trial Title:
Clinical Trial of SIBP-03 in Patients With Head and Neck Squamous Cell Carcinoma
NCT ID:
NCT06194656
Condition:
Head and Neck Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Antineoplastic Agents, Immunological
Cetuximab
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Conditions: Keywords:
Head and neck squamous cell carcinoma
safety
tolerability
pharmacokinetics
efficacy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Ⅱa is an open-label study and Ⅱb is a randomized, double-blind study.
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
HER3 Monoclonal antibodies-Dose A
Description:
Dose A, intravenous infusion (IV), once every three weeks, 21 days as a cycle. The
infusion time is 90 min (± 5 min).
Arm group label:
Group A
Intervention type:
Drug
Intervention name:
HER3 Monoclonal antibodies-Dose B
Description:
Dose B, intravenous infusion (IV), once every three weeks, 21 days as a cycle. The
infusion time is 90 min (± 5 min).
Arm group label:
Group B
Intervention type:
Drug
Intervention name:
HER3 Monoclonal antibodies-Dose C
Description:
Dose C, intravenous infusion (IV), once every three weeks, 21 days as a cycle. The
infusion time is 90 min (± 5 min).
Arm group label:
Group C
Intervention type:
Other
Intervention name:
HER3 Monoclonal antibodies-Dose D
Description:
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).
Arm group label:
Group D
Intervention type:
Other
Intervention name:
Placebo
Description:
SIBP-03 solvent without HER3 antibody, intravenous infusion (IV), once every one weeks,
21 days as a cycle.
Arm group label:
Group E
Intervention type:
Combination Product
Intervention name:
Cetuximab injection
Description:
Medications used for combination therapy, intravenous infusion (IV). Administer once a
week.
Arm group label:
Group A
Arm group label:
Group B
Arm group label:
Group C
Arm group label:
Group D
Arm group label:
Group E
Summary:
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.
Detailed description:
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. The participants in
both study parts are the same, both of whom were patients with recurrent/metastatic
advanced HNSCC (non nasopharyngeal carcinoma).
- a is an open-label study. Part one, 12 subjects were randomly assigned 1:1 to two
groups and treated with SIBP-03 dose A or dose B every 3 weeks (Q3W) combined with
cetuximab every week (QW). Part two, 3 subjects were treated with SIBP-03 dose C Q3W
combined with cetuximab QW. If 1/3 subjects (1 case) have DLT, 3 more subjects need
to continue to observe the safety and tolerance; If DLT occurs in 3 cases or ≥ 2
cases in 6 cases, the sponsor and the researcher will discuss and decide whether to
terminate this part of the study or change the dose. 12 subjects were added at most.
- b is a randomized, double-blind study. Including an experimental group (RP2D) and a
placebo control group. The qualified subjects in this stage will be randomly
assigned according to the ratio of 2: 1, including 38 cases in the experimental
group and 19 cases in the control group, with a total of 57 subjects.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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.
- There must be at least one measurable lesion as the target lesion (according to
RECIST v1.1 standard). Tumor lesions located in previous radiotherapy areas or other
local regional treatment sites are generally not measurable lesions unless the
lesion has definite progression.
- The ECOG physical fitness score is 0-1.
- The laboratory test results meet the requirements.
- The expected survival time is ≥ 3 months.
- In fertile female subjects, the blood pregnancy test must be negative within 7 days
before the first medication. Subjects of reproductive age (including male subjects)
had no family planning during the trial period and within 6 months after the last
administration and voluntarily took effective contraceptive measures.
Exclusion Criteria:
- 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.
- In the past 5 years, the subjects had suffered from malignant tumors other than
those treated in this study (except cured thyroid cancer, skin basal cell carcinoma
and cervical carcinoma in situ).
- People infected with active human immunodeficiency virus (HIV), hepatitis C virus
(HCV), hepatitis B vrius (HBV), syphilis or active tuberculosis, and asymptomatic
chronic hepatitis B or hepatitis C carriers may be excluded.
- The subjects have not recovered from the toxicity of previous anti-tumor therapy to
grade ≤ 1 or baseline level (except participants with hair loss, neuropathy of grade
≤ 2 or stabilized thyroid function's decline by hormon replacement therapy).
- Subjects are currently participating in and receiving research treatment or have
been treated with other research drugs or medical devices within 4 weeks before the
first use of research drugs.
- Patients who plan to receive any other anti-tumor treatment during the trial should
be excluded.
- Major surgery, radiotherapy (except palliative radiotherapy for targeted bone
metastasis), or treatment such as unhealed surgical wound, ulcer or fracture within
4 weeks before the first administration; Received Chinese patent medicines or
Chinese herbal medicines with anti-tumor indications within 2 weeks before the first
administration; Chemotherapy was received within 3 weeks before the first
administration, and anti-tumor treatments such as biotherapy, endocrine therapy,
targeted therapy and immunotherapy were received within 4 weeks
- Those who have been vaccinated live within 30 days before the first administration.
- Active infections requiring systemic treatment, such as pneumonia, bacteremia,
septicemia, etc.
- A history of pulmonary interstitial disease, pulmonary interstitial fibrosis or
drug-induced interstitial pneumonia or other clinically serious lung diseases (CTCAE
5.0 grade III-IV).
- Pulmonary thromboembolism, arterial thrombosis and deep vein thrombosis formation
(DVT) occurred within 6 months before screening, except for infusion set-related
thrombosis.
- Have a history or evidence of cardiovascular (CV) risk.
- During the screening period, 12-lead electrocardiogram (ECG) measurement was
performed in the research center (the average value of QTcF that needs to be
measured repeatedly for 3 times), and the QT interval (QTcF) corrected by Fridericia
method was > 450 milliseconds (male) or (QTcF) > 470 milliseconds (female); LVEF of
cardiac ultrasound was less than 50%.
- Therapeutic surgery was performed within 28 days before the first administration, or
major surgery was expected during the study period (except diagnosis, biopsy and
drainage).
- People with mental disorders or poor compliance.
- Pregnant or lactating women.
- According to the researcher's judgment, there are accompanying diseases (such as
severe hypertension, diabetes, thyroid diseases, etc.) that seriously endanger the
patient's safety or affect the patient's completion of the study.
- Suffering from diseases requiring long-term treatment with high doses (defined as
30mg/d hydrocortisone or equivalent doses of other hormonal drugs) of hormones or
immunosuppressive drugs.
- After active treatment, uncontrollable pleural and abdominal cavity or other lacunar
effusion.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai East Hospital
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Ye Guo, Doctor
Start date:
September 27, 2024
Completion date:
July 30, 2026
Lead sponsor:
Agency:
Shanghai Institute Of Biological Products
Agency class:
Industry
Source:
Shanghai Institute Of Biological Products
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06194656
