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

Solid Tumor, Adult Clinical Trial

Official title:

A Phase I/II Clinical Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics (PK/PD) and Preliminary Efficacy of ABO2011 as Monotherapy in Patients With Advanced Solid Tumors Progressed on or After Systemic Standard Treatments

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06088004
• Other study ID #: ABO2011-103
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: September 28, 2023
• Est. completion date: December 7, 2026

Study information

• Verified date: September 2023
• Source: Suzhou Abogen Biosciences Co., Ltd.
• Contact: Fuzheng Huo
• Phone: 010-57593072
• Email: fuzheng.huo[@]abogenbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 in patients with advanced solid tumors who have progressed or metastasized after systemic standard of treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 7, 2026
• Est. primary completion date: December 23, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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. Have histopathology or cytology confirmed progressed or metastatic Advanced solid tumors;

4. Disease progression or intolerance toxicity after previous systematic standard therapy, and lack of effective treatment of advanced solid tumors;

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. At least one measurable lesion, as evaluated by the investigator, in addition to the presence of lesions that can be used for intratumoral injection of ABO2011.

9. Meet the required level of organ function.

10. 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 (ß-blockers, calcium channel blockers, and digoxin are allowed).

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.

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor, Adult

Intervention

Drug:
• ABO2011 Injection
Name of Active Ingredient: mRNA encoding human single-chain IL-12 protein; ABO2011 injection Route of administration: intratumoral injection

Locations

Country	Name	City	State
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing
China	Shanxi Cancer hospital	Shanxi
China	Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center	Shenzhen

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Abogen Biosciences Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase I: Incidence and character of DLTs		21 days after the first dosing
Primary	Phase I: Incidence of Adverse Event (AE)		from informed consent until 28 days after the last administration
Primary	Phase I: Incidence of Serious Adverse Event (SAE)		from informed consent until 28 days after the last administration
Primary	Phase I: Incidence of patients with clinically significant abnormal laboratory results		from first dose until 28 days of last administration
Primary	Phase II: Objective response rates		Estimated to be from time of informed consent up to 2 years