Evaluating ABO2011 for 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 study is testing a new treatment called ABO2011, alone or with another drug, to see if it can help people with advanced solid tumors feel better and improve their health.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 218 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Suzhou Abogen Biosciences Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, Toripalimab
• Locations: 5 sites (Beijing and 4 other locations)
• Trial ID: NCT06088004 on ClinicalTrials.gov

What this trial studies

This clinical study is an open-label, single-arm, dose-escalation, and dose-expansion evaluation of ABO2011, either alone or in combination with Toripalimab, in patients with advanced solid tumors. The study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of the treatment. Participants will receive injections of ABO2011 and may also receive Toripalimab, with the goal of determining the optimal dosing and effectiveness of these therapies.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with confirmed advanced solid tumors who have failed previous systemic treatments.

Not a fit: Patients with early-stage tumors or those who have not yet undergone systemic treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors who have limited alternatives.

How similar studies have performed: Other studies evaluating similar immunotherapy approaches have shown promising results, suggesting potential for success in this trial.

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.

Where this trial is running

Beijing and 4 other locations

• Cancer Hospital Chinese Academy of Medical Sciences — Beijing, China (Recruiting)
• Sun Yat-sen University Cancer Center — Guangzhou, China (Recruiting)
• Guangxi Medical University Cancer Hospital — Nanning, China (Recruiting)
• Shanxi Cancer hospital — Shanxi, China (Recruiting)
• Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center — Shenzhen, China (Recruiting)

Study contacts

• Principal investigator: Ning Li — Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Study coordinator: Nong Chen

Conditions Solid Tumor, Adult