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RECRUITING
NCT06088004
PHASE1/PHASE2

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

Sponsor: Suzhou Abogen Biosciences Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

218

Start Date

2023-09-28

Completion Date

2027-12-30

Last Updated

2025-08-22

Healthy Volunteers

No

Interventions

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

Locations (5)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, China

Sun Yat-sen University Cancer Center

Guangzhou, China

Guangxi Medical University Cancer Hospital

Nanning, China

Shanxi Cancer hospital

Shanxi, China

Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center

Shenzhen, China