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New treatment option for Solid Tumor, Adult
Official title Phase Ⅰ/Ⅱ Clinical Study to Evaluate ABO2011 in Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06088004
What this study is testing
What is ABO2011 Injection?
ABO2011 Injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for solid tumor, adult.
Also referred to as ABO2011, ABOD2011.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people must be ≥18 years olde.
- Ability to sign informed consent, including compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and this...
- Histopathology or cytology confirmed Advanced solid tumors;
- Failed of previous systemic treatment or required treatment histories for selected tumor types;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
You likely can't join if
- Other malignancies within the previous 5 years, with the exception of cured basal cell carcinoma of the skin, superficial bladder cancer, carcinoma...
- Central nervous system tumors or metastases with clinical symptoms or asymptomatic brain metastases requiring steroids control.
- History of serious cardiac disease, e.g., New York Heart Association (NYHA) ≥ Grade 2 cardiac failure, history of transmural myocardial infarction...
- Poorly controlled clinical complications, including, but not limited to, uncontrolled hypertension with both antihypertensive agents Hypertension and...
- Active autoimmune diseases and inflammatory diseases, such as systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid...
- The subject carried: Known Human Immunodeficiency Virus (HIV); Active hepatitis B virus infection; Active hepatitis C virus infection.
See the full eligibility criteria
- people must be ≥18 years olde.
- Ability to sign informed consent, including compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and this protocol.
- Histopathology or cytology confirmed Advanced solid tumors;
- Failed of previous systemic treatment or required treatment histories for selected tumor types;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Expected survival greater than 12 weeks.
- At least one superficial or deep lesion for intratumoral injection and biopsy.
- Meet the required level of organ function.
- 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...
- 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.
- Central nervous system tumors or metastases with clinical symptoms or asymptomatic brain metastases requiring steroids control.
- 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...
- 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...
- 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...
- The subject carried: Known Human Immunodeficiency Virus (HIV); Active hepatitis B virus infection; Active hepatitis C virus infection.
- Thrombotic disease or use of full-dose anticoagulant drugs within 6 months prior to screening.
- Radiotherapy within 14 days prior to the first dose.
- 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.
- Major surgery within 28 days prior to the first dose or non-study-related minor surgery within 14 days prior to the first dose.
- 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...
- Acute toxic effects of prior anticancer chemotherapy or immunotherapy have not been stable, or significant post-treatment toxicities have been observed.
- Any systemic anti-tumor therapy with specific washout windows.
- Presence of clinically significant pulmonary fibrosis or interstitial pneumonia.
- Presence of active infections, including bacteria, fungi, viruses, and tuberculosis.
- Active bleeding, including but not limited to gastrointestinal bleeding, hemoptysis, etc.
- History of immediate severe allergic reactions prior to the first dose.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
- Guangzhou, China
- Nanning, China
- Shanxi, China
- Shenzhen, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China; Guangzhou, China; Nanning, China; Shanxi, China; Shenzhen, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.