NCT05303090

Oncolytic Virotherapy Plus PD-1 Inhibitor and Lenvatinib for Patients With Advanced Pancreatic Cancer

A Phase 1b Dose-escalation and Cohort-expansion Study of the Safety/Tolerability, and Efficacy of Oncolytic Virotherapy Plus PD-1 Inhibitor and Lenvatinib for Patients With Advanced Pancreatic Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the safety/tolerability efficacy of oncolytic virotherapy combined with Tislelizumab plus lenvatinib for advanced pancreatic cancer patients who were relapsed or refractory to standard therapy

Detailed description

Recent studies have suggested that local destruction of tumor tissue by oncolytic virus induced activation and maturation of dendritic cells and tumor-specific T cells by cross-presentation of tumor antigens. While pd-1 blocking antibody interferes with PD-1 mediated T-cell regulatory signaling. And combination of pd-1 blocking antibody plus lenvatinib showed increased ORR in many types of human cancers. Therefore, the objective of this study is to evaluate the safety and efficacy of oncolytic virotherapy combined with Tislelizumab plus lenvatinib for advanced pancreatic cancer patients who were relapsed or refractory to standard therapy.

Conditions

• Pancreatic Ductal Adenocarcinoma

Interventions

Type	Name	Description
DRUG	H101	H101 intratumorally injection starts at day 0.
DRUG	Tislelizumab	Tislelizumab plus lenvatinib will be initiated on day 1. Tislelizumab will be administered at 200 mg i.v. every 3 weeks orally daily every 3 weeks until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
DRUG	lenvatinib	lenvatinib (bodyweight ≥ 60 kg, 12 mg; \< 60 kg, 8 mg) orally daily every 3 weeks until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.

Timeline

• Start date: 2022-03-31
• Primary completion: 2024-04-23
• Completion: 2024-04-23
• First posted: 2022-03-31
• Last updated: 2025-02-27

Locations

1 site across 1 country: China