Evaluating P-IL-2 alone and with Anti-PD-1 for various cancers
The IIT Study of Evaluation of Platelet-coupled IL-2 Cell Injection (P-IL-2) Single Agent and With Anti-PD-1 Monoclonal Antibody on the Safety, Tolerance and Preliminary Effectiveness in Patients With Advanced Malignant Solid Tumors
This study is testing if a new treatment called P-IL-2, alone or with another drug, can help people with advanced cancers like esophagus, bladder, liver, ovarian, and small-cell lung cancer feel better and live longer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT05829057 on ClinicalTrials.gov |
What this trial studies
This phase 1 clinical trial investigates the safety and efficacy of P-IL-2, both as a single agent and in combination with an Anti-PD-1 monoclonal antibody, in patients with advanced solid tumors such as esophagus, bladder, liver, ovarian, and small-cell lung cancers. The study employs a single-dose escalation design, starting with an accelerated titration followed by a traditional '3+3' dose escalation method. A total of 10-19 subjects are expected to participate, with safety monitored through dose-limiting toxicity (DLT) assessments over a 28-day observation period. Participants will be followed for survival and disease progression for up to two years post-treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with advanced solid tumors who have experienced disease progression or lack effective standard treatment.
Not a fit: Patients with early-stage cancers or those who have not yet undergone standard treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced cancers that have not responded to standard treatments.
How similar studies have performed: While this approach is novel in its specific combination, similar studies using immunotherapy have shown promising results in treating various cancers.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Willing and able to follow study procedures , and sign a written informed consent form;
2. Males or females aged 18-75 years old at the time of signing the ICF;
3. Expected survival time ≥ 12 weeks.
4. Physical condition score ECOG ≤ 1.
5. There is still disease progression, intolerance or lack of effective standard treatment under standard treatment. Patients with advanced malignant solid tumor confirmed by pathology (recurrence and / or metastasis); at least 1 Measurable lesions in accordance with RECIST v1.1 or iRECIST standards.
6. Before the first administration, it had recovered from the toxic effects of the last treatment, and the researchers determined that the corresponding AE did not have a safety risk.
7. 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 count during the screening period), platelets Count ≥ 100x109 shock L, hemoglobin ≥ 90g/L, and no blood transfusion within 14 days before the first administration.
8. Male subjects and female subjects of childbearing age from the signing of informed consent form to the end of drug research. Voluntary use of effective contraceptive measures within 5 months after secondary use.
Exclusion Criteria:
1. Past or present suffering from other types of malignant tumors.
2. Known to be allergic to research drugs or any of their excipients, or to be too strict with other monoclonal antibodies.Severe anaphylaxis (NCI-CTCAE 5.0 grade ≥ 3).
3. People have hemorrhagic diseases or have hemorrhagic tendencies.
4. 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 of drug 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 weeks before drug treatment for the first time.
5. Patients with a history of central nervous system metastasis (non-tumor meningeal metastasis) or spinal cord compression can be enrolled in the study if they have clearly received treatment and have stopped taking anticonvulsants and steroids for 4 weeks or more and have stable clinical manifestations before the first administration of the study.
6. Symptomatic, visceral spread, and short-term risk of life-threatening complications. the patients who underwent puncture and drainage within 3 weeks before the first administration included pleural effusion and abdominal cavity. Patients with effusion and pericardial effusion.
7. Subjects with active, or history of autoimmune diseases that may recur, or patients at high 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.
8. Within 6 months before screening, any cardiovascular disease met any of the following criteria:
* 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 of apical torsion ventricular tachycardia are of clinical significance .
* myocardial infarction and severe / unstable angina pectoris occurred within 6 months before administration.
* history of thromboembolism with grade 3 or more in the past 2 years, or is being received because of a high risk of thrombosis.
Receive thrombolytic or anticoagulant therapy.
9. Currently suffering from sudden lung disease, interstitial lung disease or pneumonia, pulmonary fibrosis, acute lung disease, etc., except local interstitial pneumonia caused by radiotherapy.
10. Uncontrolled systemic diseases .
11. history of human immunodeficiency virus infection, or suffer from other acquired, congenital immunodeficiency. Disease, or a history of organ transplantation, or a history of stem cell transplantation;
12. Evidence of active infection.
13. Previous history of neurological or mental disorders, or known history of psychotropic substance abuse and alcoholism.
History or history of drug use.
14. Received any research drug within 4 weeks before the first administration, or participated in another clinical trial at the same time.
15. Female patients who are pregnant or lactating, or whose baseline pregnancy test results are positive.
16. The researchers believe that it is not suitable for patients to be included in this study.
Where this trial is running
Hangzhou, Zhejiang
- First affiliated hospital, Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: weijia weijia — stem cell and somatic cell clinical study committee
- Study coordinator: weijia weijia
- Email: weijiafang@zju.edu.cn
- Phone: 0086-571-87235144
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.