NCT07136285

Olvi-Vec Combined With Platinum Plus Etoposide Therapy in Patients With Late Phase SCLC

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: Newsoara HYK Biopharmaceutical (Shanghai) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Oncolytic virus product named Olvi-Vec combined with Platinum plus Etoposide in patients with late phase SCLC

Detailed description

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.

Conditions

• SCLC, Extensive Stage

Interventions

Type	Name	Description
DRUG	Olvi-Vec	Olvi-Vec will be administered to patient for 3 days during C1
DRUG	platinum (cisplatin or carboplatin)	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.
DRUG	Etoposide	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.

Timeline

• Start date: 2023-07-24
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-08-22
• Last updated: 2025-12-03

Locations

2 sites across 1 country: China