NCT06088004

Phase Ⅰ/Ⅱ Clinical Study to Evaluate ABO2011 in Advanced Solid Tumors

A Phase I/II Clinical Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics (PK/PD) and Preliminary Efficacy of ABO2011 Monotherapy or in Combination With Toripalimab in Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 218 (estimated)
• Sponsor: Suzhou Abogen Biosciences Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, single-arm, dose-escalation, and dose-expansion clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of ABO2011 monotherapy or in combination with Toripalimab in patients with advanced solid tumors.

Conditions

• Solid Tumor, Adult

Interventions

Type	Name	Description
DRUG	ABO2011 Injection	Name of Active Ingredient: mRNA encoding human single-chain IL-12 protein; ABO2011 injection Route of administration: intratumoral injection
DRUG	Toripalimab	Anti-PD-1 antibody

Timeline

• Start date: 2023-09-28
• Primary completion: 2026-12-30
• Completion: 2027-12-30
• First posted: 2023-10-18
• Last updated: 2025-08-22

Locations

5 sites across 1 country: China