Last updated: February 8, 2024
Sponsor: Zhejiang University
Overall Status: Active - Recruiting
Phase
1
Condition
Bladder Cancer
Ovarian Cancer
Liver Cancer
Treatment
P-IL-2 plus Anti-PD-1 Monoclonal Antibody
Intravenous injection of P-IL-2
Clinical Study ID
NCT05829057
ZS205
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Willing and able to follow study procedures , and sign a written informed consentform;
- Males or females aged 18-75 years old at the time of signing the ICF;
- Expected survival time ≥ 12 weeks.
- Physical condition score ECOG ≤ 1.
- There is still disease progression, intolerance or lack of effective standardtreatment under standard treatment. Patients with advanced malignant solid tumorconfirmed by pathology (recurrence and / or metastasis); at least 1 Measurable lesionsin accordance with RECIST v1.1 or iRECIST standards.
- Before the first administration, it had recovered from the toxic effects of the lasttreatment, and the researchers determined that the corresponding AE did not have asafety risk.
- Organ and bone marrow function levels must meet the following requirements: Bone marrow: absolute neutrophil count (ANC) ≥ 1.5 × 109 ppm L, specified value (according to Group determination, see Appendix 11 for instructions on platelet countduring the screening period), platelets Count ≥ 100x109 shock L, hemoglobin ≥ 90g/L,and no blood transfusion within 14 days before the first administration.
- Male subjects and female subjects of childbearing age from the signing of informedconsent form to the end of drug research. Voluntary use of effective contraceptivemeasures within 5 months after secondary use.
Exclusion
Exclusion Criteria:
- Past or present suffering from other types of malignant tumors.
- Known to be allergic to research drugs or any of their excipients, or to be too strictwith other monoclonal antibodies.Severe anaphylaxis (NCI-CTCAE 5.0 grade ≥ 3).
- People have hemorrhagic diseases or have hemorrhagic tendencies.
- Received any of the following treatments or drugs before the first study:
- large surgery or severe trauma occurred within 4 weeks before the first study ofdrug treatment.
- previous use of immunosuppressive drugs within 2 months prior to the first study,excluding nasal spray.
- And inhaled corticosteroids or physiological doses of systemic steroids.
- to study the Chinese medicine therapy with anti-tumor indications within 2 weeksbefore drug treatment for the first time.
- Patients with a history of central nervous system metastasis (non-tumor meningealmetastasis) or spinal cord compression can be enrolled in the study if they haveclearly received treatment and have stopped taking anticonvulsants and steroids for 4weeks or more and have stable clinical manifestations before the first administrationof the study.
- Symptomatic, visceral spread, and short-term risk of life-threatening complications.the patients who underwent puncture and drainage within 3 weeks before the firstadministration included pleural effusion and abdominal cavity. Patients with effusionand pericardial effusion.
- Subjects with active, or history of autoimmune diseases that may recur, or patients athigh risk. subjects with the following diseases are allowed to join the group:
- stable type I diabetic patients treated with fixed dose of insulin.
- autoimmune hypothyroidism which only needs hormone replacement therapy.
- skin diseases that do not require systemic treatment.
- cured childhood asthma / allergy adult patients without any intervention.
- Within 6 months before screening, any cardiovascular disease met any of the followingcriteria:
- congestive heart failure with heart function ≥ New York Heart Association (NYHA)Class II; left ventricular ejection. Blood fraction (LVEF) < 50%.
- severe arrhythmias requiring drug treatment.
- QTcF (Fridericia formula) male > 450ms, female > 470ms, or exist risk factors ofapical torsion ventricular tachycardia are of clinical significance .
- myocardial infarction and severe / unstable angina pectoris occurred within 6months before administration.
- history of thromboembolism with grade 3 or more in the past 2 years, or is beingreceived because of a high risk of thrombosis. Receive thrombolytic or anticoagulant therapy.
- Currently suffering from sudden lung disease, interstitial lung disease or pneumonia,pulmonary fibrosis, acute lung disease, etc., except local interstitial pneumoniacaused by radiotherapy.
- Uncontrolled systemic diseases .
- history of human immunodeficiency virus infection, or suffer from other acquired,congenital immunodeficiency. Disease, or a history of organ transplantation, or ahistory of stem cell transplantation;
- Evidence of active infection.
- Previous history of neurological or mental disorders, or known history of psychotropicsubstance abuse and alcoholism. History or history of drug use.
- Received any research drug within 4 weeks before the first administration, orparticipated in another clinical trial at the same time.
- Female patients who are pregnant or lactating, or whose baseline pregnancy testresults are positive.
- The researchers believe that it is not suitable for patients to be included in thisstudy.
Study Design
Total Participants: 10
Treatment Group(s): 2
Primary Treatment: P-IL-2 plus Anti-PD-1 Monoclonal Antibody
Phase: 1
Study Start date:
May 23, 2023
Estimated Completion Date:
June 21, 2025
Study Description
Connect with a study center
First affiliated hospital, Zhejiang University
Hangzhou, Zhejiang 310006
ChinaActive - Recruiting
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