Esophagus CancerPhase 1NCT05829057
The IIT Study of Evaluation of P-IL-2 Single Agent and With Anti-PD-1
A Phase 1 study testing Intravenous injection of P-IL-2 and P-IL-2 plus Anti-PD-1 Monoclonal Antibody in people with Esophagus Cancer and Bladder Cancer, run by Zhejiang University at 1 site in China.
Trial summary
Phase Ia: single-dose escalation study: accelerated titration combined with traditional "3+3" dose. Sample size is correlated with the DLT occurring in each dose group. 4 dose groups are expected; the first dose group is the accelerated titration group, which includes only 1 subject; subsequent dose groups are in… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophagus Cancer, Bladder Cancer, Liver Cancer
- What is being tested?
- Intravenous injection of P-IL-2 and P-IL-2 plus Anti-PD-1 Monoclonal Antibody
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 23 May 2023to 21 Jun 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to follow study procedures , and sign a written informed consent form;
- 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 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.
- 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.
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- 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.
- 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.
Who cannot join
- 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 strict with 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 of drug treatment.
- previous use of immunosuppressive drugs within 2 months prior to the first study, excluding nasal spray.
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- 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.
- 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.
- 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.
- 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.
- 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.
- Currently suffering from sudden lung disease, interstitial lung disease or pneumonia, pulmonary fibrosis, acute lung disease, etc., except local interstitial pneumonia caused 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 a history of stem cell transplantation;
- Evidence of active infection.
- Previous history of neurological or mental disorders, or known history of psychotropic substance abuse and alcoholism.
- History or history of drug use.
- Received any research drug within 4 weeks before the first administration, or participated in another clinical trial at the same time.
- Female patients who are pregnant or lactating, or whose baseline pregnancy test results are positive.
- The researchers believe that it is not suitable for patients to be included in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First affiliated hospital, Zhejiang University
Hangzhou, Zhejiang, 310006
Weijia fang, MD, 13758211655, weijia.fang@163.com
Weijia fang, MD
About this study
Official title: 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
Phase Ia: single-dose escalation study: accelerated titration combined with traditional "3+3" dose. Sample size is correlated with the DLT occurring in each dose group. 4 dose groups are expected; the first dose group is the accelerated titration group, which includes only 1 subject; subsequent dose groups are in traditional "3+3" dose increments, with 3-6 subjects in each group; a total of 10-19 subjects are expected in all dose groups. If the DLT is still not present in the highest dose ,the safety monitoring committee(SMC) to determine if it is necessary to continue incrementally to a higher dose.
Read the detailed description
P-IL-2 injection was injected intravenously, the screening period was 28 days, and the DLT observation period was 28 days from the beginning of the first infusion (including the day of administration). After the end of the DLT observation period, subjects can continue to receive treatment on a voluntary basis. The safety follow-up after drug withdrawal was carried out 28 days after the last medication. During the survival follow-up after drug withdrawal, imaging examination and survival information were collected every 12 weeks as far as possible within 2 years after drug withdrawal, until the subjects developed disease or received other anti-tumor specific therapy. Subjects with disease progression or other treatment received telephone survival follow-up every 12 weeks. After 2 years of drug withdrawal, telephone survival follow-up was conducted every 12 weeks according to the wishes of the subjects.
- Being tested
- Intravenous injection of P-IL-2, P-IL-2 plus Anti-PD-1 Monoclonal Antibody
- Keywords
- cancer
- Medical subject headings
- Esophageal Neoplasms, Urinary Bladder Neoplasms, Liver Neoplasms, Ovarian Neoplasms, Small Cell Lung Carcinoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous injection of P-IL-2Biological
Ia :Single dose intravenous injection of P-IL-2；
P-IL-2 plus Anti-PD-1 Monoclonal AntibodyBiological
Ib：P-IL-2 plus Anti-PD-1 Monoclonal Antibody；
| Study group | Role | What they receive |
|---|---|---|
| Arm of P-IL-2 | Experimental | Ia:Subjects will be dosed with single dose of P-IL-2 Receives: Biological: Intravenous injection of P-IL-2 |
| P-IL-2 plus Anti-PD-1 Monoclonal Antibody | Experimental | Ib:Subjects will be dosed with dose of P-IL-2 plus Anti-PD-1 Monoclonal Antibody Receives: Biological: P-IL-2 plus Anti-PD-1 Monoclonal Antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number and severity of DLTs.
DLT refers to toxicities that occur within 28 days of the subject's first dose and are judged by the investigator to be related to the study drug and meet the following conditions, including any ≥4 hematologic toxicity and non-hematologic toxicity. All toxicity or adverse events (AEs) are graded according to NCI-CTCAE 5.0.
Measured: 28 days after infusion
Incidence of AE and SAE
Incidence and Severity of AE and SAE; An AE was any untoward medical occurrence after clinical study subjects receive study drug. An SAE was any event that meets any the following criteria: death, life-threatening; inpatient hospitalization or prolongation, persistent or significant disability/incapacity; congenital malformation/birth defects and significant medical events. AE and SAE were graded by CTCAE version 5.0 by severity, from Grade 1 mild to Grade 5 death related AE.
Measured: 24 month after infusion
Number of participants with physical examinations
Make list of patients who were normal before administration and abnormal after administration, physical examinations includes general appearance and examinations of the skin, eyes, ears, nose, throat, lungs, heart, abdomen, limbs, musculoskeletal system, nervous system and lymphatic system.
Measured: 24 months after infusion
Secondary outcomes (4)
changes in the number of CD3+ cells relative to the baseline.
Peripheral blood collection, number of CD3+ cells is detected by qPCR
Measured: Within 28 days after infusion
changes of immunoglobulin IgG relative to the baseline.
Peripheral blood collection, to monitor the changes of IgG
Measured: Within 28 days after infusion
changes of immunoglobulin IgE relative to the baseline.
Peripheral blood collection, to monitor the changes of IgE
Measured: Within 28 days after infusion
changes of cytokines relative to the baseline
Peripheral Blood collection，cytokines include IFN-γ、TNF-α、IL-2、IL-6、IL-10
Measured: Within 28 days after infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start23 May 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion21 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophagus CancerStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Arms and Interventions： Experimental: Arm of P-IL-2 Based on platelet count： Cohort 1：8×10\^9 PLT； Cohort 2：2.5×10\^10 PLT； Cohort 3：8×10\^10 PLT； Cohort 4：2.5×10\^11 PLT/kg BW； Experimental: P-IL-2 plus Anti-PD-1 Monoclonal Antibody
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Zcapsule Pharmaceuticals (Shaoxing) Co., Ltd
- Responsible party
- Principal investigator, Weijia Fang, MD, Zhejiang University
- Investigators
- weijia weijia, Principal investigator, stem cell and somatic cell clinical study committee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05829057
- Sponsor's protocol ID
- ZS205
- Status last verified
- Feb 2024
- First submitted
- 14 Mar 2023
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05829057
- Acronym / sponsor ID
- ZS205
- Keywords
- cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Zcapsule Pharmaceuticals (Shaoxing) Co., Ltd
- Study start
- 23 May 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 21 Jun 2025 (estimated)
- First posted
- 25 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase Ia: single-dose escalation study: accelerated titration combined with traditional "3+3" dose. Sample size is correlated with the DLT occurring in each dose group. 4 dose groups are expected; the first dose group is the accelerated titration group, which includes only 1 subject; subsequent dose groups are in traditional "3+3" dose increments, with 3-6 subjects in each group; a total of 10-19 subjects are expected in all dose groups. If the DLT is still not present in the highest dose ,the safety monitoring committee(SMC) to determine if it is necessary to continue incrementally to a higher dose.
Detailed description
P-IL-2 injection was injected intravenously, the screening period was 28 days, and the DLT observation period was 28 days from the beginning of the first infusion (including the day of administration). After the end of the DLT observation period, subjects can continue to receive treatment on a voluntary basis. The safety follow-up after drug withdrawal was carried out 28 days after the last medication. During the survival follow-up after drug withdrawal, imaging examination and survival information were collected every 12 weeks as far as possible within 2 years after drug withdrawal, until the subjects developed disease or received other anti-tumor specific therapy. Subjects with disease progression or other treatment received telephone survival follow-up every 12 weeks. After 2 years of drug withdrawal, telephone survival follow-up was conducted every 12 weeks according to the wishes of the subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Arms and Interventions： Experimental: Arm of P-IL-2 Based on platelet count： Cohort 1：8×10^9 PLT； Cohort 2：2.5×10^10 PLT； Cohort 3：8×10^10 PLT； Cohort 4：2.5×10^11 PLT/kg BW； Experimental: P-IL-2 plus Anti-PD-1 Monoclonal Antibody
| Arm | Type | Receives |
|---|---|---|
| Arm of P-IL-2 | Experimental | Biological: Intravenous injection of P-IL-2Ia:Subjects will be dosed with single dose of P-IL-2 |
| P-IL-2 plus Anti-PD-1 Monoclonal Antibody | Experimental | Biological: P-IL-2 plus Anti-PD-1 Monoclonal AntibodyIb:Subjects will be dosed with dose of P-IL-2 plus Anti-PD-1 Monoclonal Antibody |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Willing and able to follow study procedures , and sign a written informed consent form;
- 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 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.
Key exclusion criteria (31 listed)
- 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 strict with 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous injection of P-IL-2Ia :Single dose intravenous injection of P-IL-2； | Biological | Arm of P-IL-2 |
| P-IL-2 plus Anti-PD-1 Monoclonal AntibodyIb：P-IL-2 plus Anti-PD-1 Monoclonal Antibody； | Biological | P-IL-2 plus Anti-PD-1 Monoclonal Antibody |
Primary outcome
the number and severity of DLTs.
Time frame: 28 days after infusion
DLT refers to toxicities that occur within 28 days of the subject's first dose and are judged by the investigator to be related to the study drug and meet the following conditions, including any ≥4 hematologic toxicity and non-hematologic toxicity. All toxicity or adverse events (AEs) are graded according to NCI-CTCAE 5.0.
Incidence of AE and SAE
Time frame: 24 month after infusion
Incidence and Severity of AE and SAE; An AE was any untoward medical occurrence after clinical study subjects receive study drug. An SAE was any event that meets any the following criteria: death, life-threatening; inpatient hospitalization or prolongation, persistent or significant disability/incapacity; congenital malformation/birth defects and significant medical events. AE and SAE were graded by CTCAE version 5.0 by severity, from Grade 1 mild to Grade 5 death related AE.
Number of participants with physical examinations
Time frame: 24 months after infusion
Make list of patients who were normal before administration and abnormal after administration, physical examinations includes general appearance and examinations of the skin, eyes, ears, nose, throat, lungs, heart, abdomen, limbs, musculoskeletal system, nervous system and lymphatic system.
4 secondary outcomes
changes in the number of CD3+ cells relative to the baseline.
Time frame: Within 28 days after infusion
changes of immunoglobulin IgG relative to the baseline.
Time frame: Within 28 days after infusion
changes of immunoglobulin IgE relative to the baseline.
Time frame: Within 28 days after infusion
changes of cytokines relative to the baseline
Time frame: Within 28 days after infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
weijia weijia principal investigator
stem cell and somatic cell clinical study committee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Intravenous injection of P-IL-2 and P-IL-2 plus Anti-PD-1 Monoclonal Antibody in people with Esophagus Cancer and Bladder Cancer, run by Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact weijia weijia (0086-571-87235144, weijiafang@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number and severity of DLTs. (time frame: 28 days after infusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024.