A Clinical Study on Oncolytic Virus Injection (R130) for the Treatment of Relapsed/Refractory Cer… (NCT05812677) | Clinical Trial Compass
UnknownEarly Phase 1
A Clinical Study on Oncolytic Virus Injection (R130) for the Treatment of Relapsed/Refractory Cervical and Endometrial Cancer
China20 participantsStarted 2023-02-06
Plain-language summary
20 participants are expected to be enrolled for this open，Single-armed clinical trial to evaluate the safety and efficacy of the recombinant herpes simplex virus â… , R130 in patients with relapsed/refractory Cervical and Endometrial Cancer.
Who can participate
Age range18 Years – 75 Years
SexFEMALE
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Inclusion criteria
✓. Patients with cervical cancer or endometrial cancer clearly diagnosed by histology and/or cytology.
✓. Failure of standard treatment or patient unwillingness to receive other antitumor therapy.
✓. Age 18 to 75 years.
✓. Subjects with ECoG score of 0-2.
✓. Expected survival of 3 months or more.
✓. Have at least one measurable lesion (according to RECIST 1.1 criteria) that is amenable to intratumoral or intraperitoneal drug delivery.
✓. Subjects must have appropriate organ function, and laboratory tests during the screening period must meet the following requirements: a) absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelets (PLT) ≥ 80 × 109/L, and hemoglobin (Hb) ≥ 85 g/L; b) serum creatinine (Cr) and blood urea nitrogen (BUN) within 1.5 times the upper limit of normal values; c) serum c) serum total bilirubin (TBIL) ≤ 2 times the upper limit of normal values; d) glutamic aminotransferase (ALT) and glutamic oxalacetic aminotransferase (AST) ≤ 2.5 times the upper limit of normal values; subjects with liver metastases do not exceed 5 times the upper limit of normal values; e) activated partial thromboplastin time (APTT), prothrombin time (PT) within 1.5 times the upper limit of normal values.
✓. Any treatment for malignancy, including radiotherapy, chemotherapy and biological agents, must be discontinued 28 days prior to R130 treatment.
Exclusion criteria
✕. Have had any serious adverse reactions associated with immunotherapy.
. Subjects with any severe and/or uncontrolled disease, including: a) poorly controlled hypertension (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg); b) suffering from class I or higher myocardial ischemia or myocardial infarction, arrhythmia (QTc ≥ 470 ms and ≥ grade 2 congestive heart failure (New York Heart Association (NYHA) classification); c) active or uncontrolled severe infection (≥ CTCAE grade 2 infection); d) Patients with previous organ transplantation, bone marrow transplantation (hematopoietic stem cell transplantation) and severe immune deficiency; e) Urine routine suggesting urine protein ≥++ and confirmed 24-hour urine protein quantification \> 1.0 g.
✕. Patients with past history of type I diabetes mellitus or HIV.
✕. Severe abnormalities in thyroid and cortisol testing; active, known or suspected autoimmune disease requiring systemic therapy.
✕. Patients with symptomatic primary or metastatic brain tumors.
✕. Patients with active tuberculosis and a strong positive OT test.
✕. Patients with active bleeding or severe coagulation dysfunction.
✕. Have had antitumor therapy, including endocrine, chemotherapy, radiotherapy, targeted therapy, immunotherapy and antitumor herbal therapy, 4 weeks prior to the first dose.