First-in-human (FIH) Phase I Trial of BS-006 in Cervical Cancer (NCT05393440) | Clinical Trial Compass
UnknownPhase 1
First-in-human (FIH) Phase I Trial of BS-006 in Cervical Cancer
China18 participantsStarted 2022-09-16
Plain-language summary
This is a two-stage phase I clinical trial with oncolytic viruses BS-006 in recurrent or metastasis cervical cancer patients who failed in second line treatment.
Who can participate
Age range
18 Years – 75 Years
Sex
FEMALE
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
. Older than 18 years old and younger than 75 years old;
. Zubrod-ECOG-WHO performance status is 0-1;
. Life expectancy is longer than 3 months;
. Pathologically proven malignant tumor originating from cervix uterine. All pathological types are acceptable except for sarcoma of any subtypes;
. Radiological confirmed progression after at least 2 lines prior treatment or intolerable toxicity events occur during the second or later line treatment: 1) Neoadjuvant or adjuvant chemotherapy for no less than 2 cycles should be regarded as a separate treatment line if disease progress within 6 months after treatment finish;2) Regional treatment such as brachytherapy, radiofrequency ablation and artery embolization therapy should not be considered as a treatment line; 3) Treatment shift due to toxicity without radiological progression should not be counted as a separate line;
. At least one measurement lesion according to RECIST 1.1;
. At least one lesion with maximum diameter is larger than 1cm and surgically accessibility;
. Patients must have recovered from prior treatment related toxicity to CTCAE grade 1 or 0;
Exclusion criteria
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
Maximal tolerable dose
Timeframe: 2 months after initiation of enrollment
2
Rate and grade of adverse events
Timeframe: From enrollment to 90 days after last treatment of all subjects
3
Cope numbers of BS-006
Timeframe: 1 hours predose and 0.5 hours post-dose for first three doses and 1 hours predose ever after
. Cervical sarcoma of any subtype or prior history of other malignancy within 5 years;
. Central nerve system metastasis;
. Lesions met the requirement outlined in the inclusion criteria are unsafe for injection evaluated by investigators;
. Severe comorbidities of any organs, including but not limit to myocardial infarction within 6 months, unstable angina pectoris, congestive heart failure, grade 3 or higher hypertension per CTCAE, cardiac arrhythmias, uncontrolled diabetes, fever of unknown reason, active digest ulcer and chronic obstructive pulmonary disease;
. History of central nervous system infectious or demyelinating disease;
. Severe infectious disease requiring constant antibiotic treatment;
. Systematic glucocorticoids use within 2 weeks or glucocorticoids need for a long term;
. Active infection of hepatitis B or C, HIV, cytomegalovirus, syphilis or other virus requiring treatment;