The IIT Study of Evaluation of P-IL-2 Single Agent and With Anti-PD-1

NCT05829057 | Recruiting Phase 1 DMC

• 1 other identifier: ZS205
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Esophagus Cancer; Bladder Cancer; Liver Cancer; Ovarian Cancer; Small-cell Lung Cancer

Keywords

cancer

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  24 months after infusion

Secondary Outcomes (4)

• changes in the number of CD3+ cells relative to the baseline.

  Within 28 days after infusion

• changes of immunoglobulin IgG relative to the baseline.

  Within 28 days after infusion

• changes of immunoglobulin IgE relative to the baseline.

  Within 28 days after infusion

• changes of cytokines relative to the baseline

  Within 28 days after infusion

Study Arms (2)

Arm of P-IL-2

EXPERIMENTAL

Ia:Subjects will be dosed with single dose of P-IL-2

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

Biological: P-IL-2 plus Anti-PD-1 Monoclonal Antibody

Interventions

Intravenous injection of P-IL-2 BIOLOGICAL

Ia :Single dose intravenous injection of P-IL-2；

Arm of P-IL-2

P-IL-2 plus Anti-PD-1 Monoclonal Antibody BIOLOGICAL

Ib：P-IL-2 plus Anti-PD-1 Monoclonal Antibody；

P-IL-2 plus Anti-PD-1 Monoclonal Antibody

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Zhejiang University: lead
• Zcapsule Pharmaceuticals (Shaoxing) Co., Ltd: collaborator

Study Sites (1)

First affiliated hospital, Zhejiang University

Hangzhou, Zhejiang, 310006, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms; Urinary Bladder Neoplasms; Liver Neoplasms; Ovarian Neoplasms; Small Cell Lung Carcinoma; Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Liver Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• weijia weijia

  stem cell and somatic cell clinical study committee

  PRINCIPAL INVESTIGATOR

Central Study Contacts

weijia weijia

CONTACT

0086-571-87235144; weijiafang@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: April 25, 2023
• Study Start: May 23, 2023
• Primary Completion: December 31, 2024
• Study Completion: June 21, 2025
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)