NCT05392699

ABOD2011 in Patients With Advanced Solid Tumors Progressed After Standard Systemic Therapy

An Open-blind Dose Escalation Study to Assess the Safety, Tolerability, and Preliminary Efficacy of ABOD2011 in Patients With Advanced Solid Tumors Progressed After Standard Systemic Therapy

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Based on the activation and regulation of immune system by cytokines, mRNA encoding cytokines has become one of the important directions of mRNA tumor drug development. This product (ABOD2011) is a new generation mRNA product for intratumoral injection. The primary objective of this study is to assess the safety and tolerability, of ABOD2011 in patients with advanced solid tumors that progressed after standard systemic therapy.

Conditions

• Patients With Advanced Solid Tumors

Interventions

Type	Name	Description
BIOLOGICAL	human single chain IL-12 mRNA-single dose	human single chain IL-12 mRNA administered as specified in the treatment arm with injection once only
BIOLOGICAL	human single chain IL-12 mRNA-multiple dose	human single chain IL-12 mRNA administered as specified in the treatment arm with injection once per week for 3 weeks

Timeline

• Start date: 2022-05-25
• Primary completion: 2025-03-01
• Completion: 2027-01-01
• First posted: 2022-05-26
• Last updated: 2022-06-22

Locations

1 site across 1 country: China