Olvi-Vec
DrugOlvi-Vec will be administered to patient for 3 days during C1
NCT Number: NCT07136285
Oncolytic virus product named Olvi-Vec combined with Platinum plus Etoposide in patients with late phase SCLC
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1 / Phase 2
Zhejiang Provincial People's Hospital, Hangzhou, China
Olvi-Vec is a genetic engineering modification of acne virus. GLP preclinical studies include the safety, pharmacology, and toxicology have been completed. Clinical studies exploring efficacy and safety in different types of tumor are ongoing.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Olvi-Vec will be administered to patient for 3 days during C1
After completing the first cycle of treatment of Olvi-Vec (+21 days after the last dose), Platinum (Carboplatin or Cisplatin)will be administrated on D1,D2 and D3 each 21 days (dosage according to the label) from Cycle 2 until disease progression or intolerable toxicity occurred.
After completing the first cycle of treatment of Olvi-Vec (+21 days after the last dose), Etoposide will be administrated on D1,D2 and D3 each 21 days (dosage according to the label) from Cycle 2 until disease progression or intolerable toxicity occurred.
Time frame: Interval between the date of enrollment and the date of withdraw and completion of study, up to a maximum of 2 years.
Frequency and severity of adverse events measured according to NCI Common Toxicity Criteria Adverse Event (CTCAE), version 5.0
Time frame: Day 1 to day 25 of treatment cycle 1
Olvi-Vec related Grade 3 or higher adverse events (AEs) which meets DLT criteria.
Time frame: Interval between the date of enrollment and the date of withdraw and completion of study, up to a maximum of 2 years.
ORR is proportion of subjects with complete response(CR) or partial response(PR). Tumor responses will be evaluated according to RECIST 1.1 criteria. Patients with no tumor assessment after baseline will be classified as non-responders.
Time frame: Interval between the date of enrollment and the date of withdraw and completion of study, up to a maximum of 2 years.
DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks) based on RECIST V1.1
Time frame: Interval between the date of enrollment and the date of withdraw and completion of study, up to a maximum of 2 years.
PFS is defined as the time from the date of first dosing till the first documentation of disease progression (per RECIST v1.1) assessed by the investigator or death due to any cause (whichever occurs first)
Contact information is provided by the study sponsor or research team.
Newsoara HYK Biopharmaceutical (Shanghai) Co., Ltd.
Industry
PIb/II, Open-label, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of I.V. Olvi-Vec Combined With Platinum Plus Etoposide in Patients With Advanced SCLC Who Are Platinum-recurrent or Platinum-refractory
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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