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

NCT06088004 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 218

Last updated 2025-08-22

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Abogen Biosciences (Shanghai) Co., Ltd

    collaborator INDUSTRY

  • Suzhou Abogen Biosciences Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Ning Li · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-28
Primary Completion
2026-12-30
Completion
2027-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06088004 on ClinicalTrials.gov