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Tests treatment safety and results for Refractory Malignant Solid Tumors
Official title Clinical Trial of IL - 22BP Safety, Tolerability, and Antitumor Activity in Refractory Solid Tumors.
ClinicalTrials.gov ID: NCT07040943
What this study is testing
What is IL-22BP?
IL-22BP is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for refractory malignant solid tumors.
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 study aims to investigate the safety and efficacy of the IL-22BP in patients with refractory malignant solid tumors.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Male or female patients: aged ≥ 18 years old and ≤ 70 years old;
- Patients with histopathologically confirmed, refractory to second-line treatment, advanced recurrent/metastatic malignant solid tumors and without...
- Eastern Cooperative Oncology Group (ECOG) performance status score: 0 - 1;
- Expected survival time ≥ 3 months;
- More than 28 days since the last chemotherapy/radiotherapy/surgery;
You likely can't join if
- Have participated in other drug clinical trials within 4 weeks;
- The tumor is located close to major blood vessels or the trachea;
- Patients with uncontrolled cardiac clinical symptoms or diseases, such as heart failure of NYHA class II or above, unstable angina pectoris, having...
- For female people: pregnant or lactating women.
- Patients have active tuberculosis, bacterial or fungal infections (≥ grade 2 of NCI-CTCAE 5.0); have active HIV infection, active HBV infection, or...
- Those with a history of psychotropic drug abuse who are unable to quit or have mental disorders;
See the full eligibility criteria
- Male or female patients: aged ≥ 18 years old and ≤ 70 years old;
- Patients with histopathologically confirmed, refractory to second-line treatment, advanced recurrent/metastatic malignant solid tumors and without standard clinical treatment regimens (such as patients with advanced...
- Eastern Cooperative Oncology Group (ECOG) performance status score: 0 - 1;
- Expected survival time ≥ 3 months;
- More than 28 days since the last chemotherapy/radiotherapy/surgery;
- More than 6 weeks since the last use of nitrosoureas or mitomycin C;
- Main organ functions are in good condition;
- Sign a written informed consent form.
- Have participated in other drug clinical trials within 4 weeks;
- The tumor is located close to major blood vessels or the trachea;
- Patients with uncontrolled cardiac clinical symptoms or diseases, such as heart failure of NYHA class II or above, unstable angina pectoris, having had a myocardial infarction within 1 year, and having clinically...
- For female people: pregnant or lactating women.
- Patients have active tuberculosis, bacterial or fungal infections (≥ grade 2 of NCI-CTCAE 5.0); have active HIV infection, active HBV infection, or HCV infection.
- Those with a history of psychotropic drug abuse who are unable to quit or have mental disorders;
- people have any active autoimmune diseases or a history of autoimmune diseases (such as, but not limited to: uveitis, enteritis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism; people with vitiligo or those...
- people are currently receiving immunosuppressive treatment.
- Have a history of drug abuse or known medical, psychological, or social conditions, such as a history of alcoholism or drug use.
- Known to be allergic, hypersensitive, or intolerant to the studied IL-22BP (including any excipients). Have a severe allergy history to any drugs, foods, or vaccines in the past, such as anaphylactic shock, allergic...
- From the screening period to 12 months after the completion of drug injection, female people have pregnancy plans or the partners of male people have pregnancy plans.
- According to the investigator's judgment, there are concomitant diseases that seriously endanger patient safety or affect the patient's completion of the study.
The study team makes the final eligibility decision.
Where it's taking place
- Chengdu, Sichuan, 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 to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chengdu, Sichuan, 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.