Evaluating ABO2011 for advanced solid tumors
Official title: 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
Run by Suzhou Abogen Biosciences Co., Ltd. · NCT06088004 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 218 (estimated) |
| Sponsor | Suzhou Abogen Biosciences Co., Ltd. Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy, Toripalimab |
| Locations | 5 sites (Beijing and 4 other locations) |
| Status | Recruiting |
| Started | September 28, 2023 |
| Main results expected | December 30, 2026 |
| Study ends | December 30, 2027 |
| Registry record updated | September 23, 2026 |
| Trial ID | NCT06088004 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older with confirmed advanced solid tumors who have failed previous systemic treatments.
✕Probably not a fit
Patients with early-stage tumors or those who have not yet undergone systemic treatment may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies evaluating similar immunotherapy approaches have shown promising results, suggesting potential for success in this trial.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
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
- Email: nong.chen@abogenbio.com
- Phone: 010-57593072
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
TMV vaccine alone or with toripalimab for recurrent head and neck cancer
This study tests a personalized TMV vaccine, alone and with toripalimab, in adults whose head and neck cancer has returned and is planning salvage surgery.
-
Toripalimab Plus Cetuximab and Irinotecan for second-line right-sided colon cancer
This phase II study tests whether a combo of toripalimab, cetuximab, and irinotecan helps adults with second-line, right‑sided, RAS/BRAF wild-type advanced colon cancer.
-
Propranolol with Toripalimab and Platinum Chemo before/around surgery in NSCLC
This study tests whether adding propranolol to toripalimab and platinum-based chemotherapy is safe and tolerable for people with resectable non-small cell lung cancer before surgery.
-
Neoadjuvant Cryo-Thermal Ablation with Toripalimab and Chemo for Resectable NSCLC
This study tests whether using Cryo-Thermal Ablation before chemo-immunotherapy helps people with resectable NSCLC see better outcomes.
-
Rimegepant plus toripalimab in advanced urothelial cancer after standard therapy
This small, early-stage study tests whether combining rimegepant with toripalimab is safe and shows signs of activity in adults with advanced urothelial cancer that did not respond to prior treatment.
-
SABR with Axitinib and Toripalimab for oligometastatic kidney cancer
This phase 2 trial tests whether giving SABR radiation together with axitinib and toripalimab can shrink tumors and help patients with up to five metastatic sites from clear cell renal cell carcinoma.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.