Clinical Trial of SIBP-03 in Patients With Head and Neck Squamous Cell Carcinoma (NCT06194656) | Clinical Trial Compass
RecruitingPhase 2
Clinical Trial of SIBP-03 in Patients With Head and Neck Squamous Cell Carcinoma
China81 participantsStarted 2024-09-27
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, th…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The occurrence of any adverse events (AE)
Timeframe: 30 days after the last dose
2
SAE (Serious Adverse Events)
Timeframe: 30 days after the last dose
3
Cmax (Peak Plasma Concentration)
Timeframe: 30 days after the last dose
4
Tmax(Peak Time)
Timeframe: 30 days after the last dose
5
T ½(Terminal elimination half-life)
Timeframe: 30 days after the last dose
6
CL(Clearance Rate)
Timeframe: 30 days after the last dose
7
Difference of ORR
Timeframe: The 1 day the test results reported after the last dose