Trial Title:
Phase Ⅰ/Ⅱ Clinical Study to Evaluate ABO2011 in Advanced Solid Tumors
NCT ID:
NCT06088004
Condition:
Solid Tumor, Adult
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ABO2011 Injection
Description:
Name of Active Ingredient: mRNA encoding human single-chain IL-12 protein; ABO2011
injection Route of administration: intratumoral injection
Arm group label:
ABO2011
Arm group label:
ABO2011 and Toripalimab
Other name:
ABO2011
Other name:
ABOD2011
Intervention type:
Drug
Intervention name:
Toripalimab
Description:
Anti-PD-1 antibody
Arm group label:
ABO2011 and Toripalimab
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Hospital Chinese Academy of Medical Sciences
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Ning Li
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Haiqiang Mai
Facility:
Name:
Guangxi Medical University Cancer Hospital
Address:
City:
Nanning
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Song Qu
Facility:
Name:
Shanxi Cancer hospital
Address:
City:
Shanxi
Country:
China
Status:
Recruiting
Contact:
Last name:
Xin Wang
Contact backup:
Last name:
Guanghua Mao
Facility:
Name:
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center
Address:
City:
Shenzhen
Country:
China
Status:
Recruiting
Contact:
Last name:
Yan Qin
Start date:
September 28, 2023
Completion date:
December 30, 2027
Lead sponsor:
Agency:
Suzhou Abogen Biosciences Co., Ltd.
Agency class:
Industry
Collaborator:
Agency:
Abogen Biosciences (Shanghai) Co., Ltd
Agency class:
Industry
Source:
Suzhou Abogen Biosciences Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06088004
