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 range18 Years – 75 Years

SexFEMALE

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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

✕. 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;

What they're measuring

Maximal tolerable dose

Timeframe: 2 months after initiation of enrollment

Rate and grade of adverse events

Timeframe: From enrollment to 90 days after last treatment of all subjects

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

Trial details

NCT IDNCT05393440

SponsorZhongnan Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-31

Contact for this trial

Shaoxing Sun, M. D.

+08613871286154 sunshaoxing@whu.edu.cn

View on ClinicalTrials.gov More Uterine Cervical Neoplasms trials