NCT04206358

Study to Evaluate OrienX010 in Combination With JS001 in the Treatment of Stage IV (M1c) Liver Metastasis From Melanoma

An Open Phase Ib Clinical Study to Evaluate OrienX010 in Combination With JS001 in the Treatment of Stage IV (M1c) Liver Metastasis From Melanoma

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Peking University Cancer Hospital & Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is an open-label, Phase Ib clinical study to evaluate Evaluate the Recombinant Human GM-CSF Herpes Simplex Virus Injection (OrienX010) in Combination with Recombinant Human Anti-PD1 Monoclonal Antibody Injection (JS001) in the Treatment of Stage IV (M1c) Liver Metastasis from Melanoma. This study is planned to enroll approximately 30 patients with Stage IV (M1c) Liver Metastasis from Melanoma who meet protocol requirements. This study is a single-arm clinical trial. All participator will be given OrienX010 in combination with JS001. JS001 injection: 3 mg/kg, IV infusion: Once every 2 weeks ; OrienX010: Maximum injection volume 8 × 10\^8 pfu, intratumoral injection: Once every 2 weeks. Treatment will be continuous and extend from first dose of study medication until to complete response, clinical related progression disease (PDr), intolerable AE, or withdrew informed consent or meet other criteria of discontinuation. For patients who have stopped the study treatment and no disease progression, follow-up visits will take place every 3 months after the end of treatment visit until the occurrence of disease progression. If disease progression occurred, the investigator will collect the anticancer treatment information and survival of individuals until 80% death event.

Conditions

• Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	OrienX010 combination with JS001	OrienX010 Produced by Oriengene Biotechnology Co., Ltd. Strength: 1.0 mL/vial. Label claim: Titer 8.0 × 10\^7Pfu/mL, NMT 1 × 10 particles11VP/mL. JS001 Produced by Junshi Biosciences Co., Ltd. Strength: 240 mg/6 mL/vial; Sterile water injection dosage form; Expiry date: 24 months; Date of manufacture: Based on the date of manufacture indicated in the product package.

Timeline

• Start date: 2019-05-13
• Primary completion: 2021-02-27
• Completion: 2023-12-31
• First posted: 2019-12-20
• Last updated: 2019-12-20

Locations

1 site across 1 country: China