A Phase II Clinical Study to Evaluate the Efficacy and Safety of SIBP-03 Injection Combined With Cetuximab in Patients With Recurrent/Metastatic Advanced Head and Neck Squamous Cell Carcinoma (Non-nasopharyngeal Carcinoma)

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other, Combination product
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Shanghai East Hospital
RECRUITING
Shanghai
Contact Information
Primary
Dandan Chen, Master
ddchen.sh@sinopharm.com
86-021-62800991
Backup
Ye Guo, Doctor
pattrickguo@gmail.com
86-13501678472
Time Frame
Start Date: 2024-09-27
Estimated Completion Date: 2026-07-30
Participants
Target number of participants: 81
Treatments
Experimental: Group A
Experimental group in Ⅱa (part one). It will be the dose A of SIBP-03. It will determine whether the dose A is the optimal recommended dosage (RP2D) based on actual study results.
Experimental: Group B
Experimental group in Ⅱa (part one). It will be the dose B of SIBP-03. It will determine whether the dose B is the RP2D based on actual study results.
Experimental: Group C
Experimental group in Ⅱa (part two). It will be the dose C of SIBP-03. It will determine whether the dose C is the RP2D based on actual study results.
Experimental: Group D
Experimental group in Ⅱb. It will be the RP2D of SIBP-03.
Placebo_comparator: Group E
Placebo of SIBP-03 (SIBP-03 solvent without HER3 antibody), and the dose will be the same with group D.
Sponsors
Leads: Shanghai Institute Of Biological Products

This content was sourced from clinicaltrials.gov

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