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

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.

Study Overview

• Status: Recruiting
• Conditions: Solid Tumor, Adult
• Intervention / Treatment: Drug: ABO2011 Injection; Drug: Toripalimab

• Study Type: Interventional
• Enrollment (Estimated): 218
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Shihui Fu; Phone Number: 010-57593072; Email: shihui.fu@abogenbio.com
• Study Contact Backup: Name: Nong Chen; Phone Number: 010-57593072; Email: nong.chen@abogenbio.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Cancer Hospital Chinese Academy of Medical Sciences
    • Principal Investigator: Ning Li
  • Guangzhou, China
    • Recruiting
    • Sun yat-sen University Cancer Center
    • Principal Investigator: Haiqiang Mai
  • Nanning, China
    • Recruiting
    • Guangxi Medical University Cancer Hospital
    • Principal Investigator: Song Qu
  • Shanxi, China
    • Recruiting
    • Shanxi Cancer Hospital
    • Principal Investigator: Xin Wang
    • Principal Investigator: Guanghua Mao
  • Shenzhen, China
    • Recruiting
    • Cancer hospital Chinese Academy of Medical Sciences, Shenzhen Center
    • Principal Investigator: Yan Qin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subjects must be ≥18 years olde.
2. Ability to sign informed consent, including compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and this protocol.
3. Histopathology or cytology confirmed Advanced solid tumors;
4. Failed of previous systemic treatment or required treatment histories for selected tumor types;
5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
6. Expected survival greater than 12 weeks.
7. At least one superficial or deep lesion for intratumoral injection and biopsy.
8. Meet the required level of organ function.
9. Female patients are postmenopausal or, if women of childbearing potential, have a urine pregnancy or a blood pregnancy that is negative. At the same time, men of childbearing potential and women of childbearing potential voluntarily use effective contraception, including abstinence or effective contraception (e.g., intrauterine or implantable contraceptives, oral contraceptives, injectable or implantable contraceptives, extended-release local contraceptives, intrauterine devices [IUDs], condoms [males], diaphragms, cervical caps, etc.) from the time of signing the ICF until 120 days after the end of treatment.

Exclusion Criteria:

1. Other malignancies within the previous 5 years, with the exception of cured basal cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of breast, and carcinoma in situ of the cervix.
2. Central nervous system tumors or metastases with clinical symptoms or asymptomatic brain metastases requiring steroids control.
3. History of serious cardiac disease, e.g., New York Heart Association (NYHA) ≥ Grade 2 cardiac failure, history of transmural myocardial infarction, unstable angina, poorly controlled arrhythmia, myocardial infarction within 6 months prior to enrollment, or arrhythmias requiring antiarrhythmic therapy (β-blockers, calcium channel blockers, and digoxin are allowed). QTcF > 480 ms.
4. Poorly controlled clinical complications, including, but not limited to, uncontrolled hypertension with both antihypertensive agents Hypertension and hypoglycemic treatment not Controlled type 2 diabetes, poorly controlled pleural, ascites, or other serious diseases requiring systemic treatment.
5. Active autoimmune diseases and inflammatory diseases, such as systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis, inflammatory bowel disease and Hashimoto's thyroiditis, etc.; type 1 diabetes mellitus, hypothyroidism controlled by replacement therapy only, and skin diseases that do not require whole body therapy (eg, vitiligo, psoriasis) may be included in the trial.
6. The subject carried: Known Human Immunodeficiency Virus (HIV); Active hepatitis B virus infection; Active hepatitis C virus infection.
7. Thrombotic disease or use of full-dose anticoagulant drugs within 6 months prior to screening.
8. Radiotherapy within 14 days prior to the first dose.
9. Live or live attenuated vaccines or other vaccines within 30 days prior to the first dose may be determined by the investigator's comprehensive assessment.
10. Major surgery within 28 days prior to the first dose or non-study-related minor surgery within 14 days prior to the first dose.
11. Immunosuppressants or other immunomodulatory medications are required within 4 weeks prior to the first dose, but physiologic doses of systemic steroids are allowed or topical. Topical use should not exceed the dose recommended in the package insert or have any signs of systemic exposure; or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation requiring the use of immunosuppressants or other immunomodulatory drugs.
12. Acute toxic effects of prior anticancer chemotherapy or immunotherapy have not been stable, or significant post-treatment toxicities have been observed.
13. Any systemic anti-tumor therapy with specific washout windows.
14. Presence of clinically significant pulmonary fibrosis or interstitial pneumonia.
15. Presence of active infections, including bacteria, fungi, viruses, and tuberculosis.
16. Active bleeding, including but not limited to gastrointestinal bleeding, hemoptysis, etc.
17. History of immediate severe allergic reactions prior to the first dose.
18. Other conditions that may increase the risk associated with the study drug, or affect the study compliance, which the investigator considers unsuitable for participation in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ABO2011; Monotherapy	Drug: ABO2011 Injection; Name of Active Ingredient: mRNA encoding human single-chain IL-12 protein; ABO2011 injection Route of administration: intratumoral injection; Other Names: ABO2011; ABOD2011
Experimental: ABO2011 and Toripalimab; Combination therapy	Drug: ABO2011 Injection; Name of Active Ingredient: mRNA encoding human single-chain IL-12 protein; ABO2011 injection Route of administration: intratumoral injection; Other Names: ABO2011; ABOD2011; Drug: Toripalimab; Anti-PD-1 antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Phase II: Objective response rates	Estimated to be from time of informed consent up to 2 years
Phase I: Incidence and character of DLTs	monotherapy: 21 days after the first dose. Combination therapy: 28 days after the first dose]
Phase I: Incidence of Adverse Event (AE)	monotherapy: from informed consent until 28 days after the last administration. Combination therapy: from informed consent until 90 days after the last administration.
Phase I: Incidence of Serious Adverse Event (SAE)	monotherapy: from informed consent until 28 days after the last administration. Combination therapy: from informed consent until 90 days after the last administration.]
Phase I: Incidence of patients with clinically significant abnormal laboratory results	monotherapy: from the first dose until 28 days of last administration. Combination therapy: from informed consent until 90 days after the last administration.

Collaborators and Investigators

• Sponsor: Suzhou Abogen Biosciences Co., Ltd.
• Collaborators: Abogen Biosciences (Shanghai) Co., Ltd
• Investigators: Principal Investigator: Ning Li, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: September 28, 2023
• First Submitted That Met QC Criteria: October 13, 2023
• First Posted (Actual): October 18, 2023

Study Record Updates

• Last Update Posted (Actual): August 22, 2025
• Last Update Submitted That Met QC Criteria: August 18, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: ABO2011-103

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No