Status:
UNKNOWN
MUC1 Therapeutic Tumor Vaccine in Advanced Solid Cancers
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Solid Tumor, Adult
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This is an investigator-initiated, single-center, open, single-arm, exploratory study of a therapeutic cancer vaccine for the treatment of advanced solid tumors. A dose-escalation trial is being condu...
Detailed Description
Malignant tumours have become one of the major public health problems that seriously threaten human health. According to the latest global cancer burden data for 2020 released by the International Age...
Eligibility Criteria
Inclusion
- screening period patients are able to understand and voluntarily sign an informed consent form;
- males and females between the ages of 18 and 75 years (both ends included);
- expected survival ≥ 3 months;
- advanced subjects with histologically or cytologically proven advanced solid tumors who have failed standard multiline therapy;
- have at least one measurable lesion (i.e., mass ≥10 mm in diameter and malignant lymph node ≥15 mm in short diameter on enhanced scan with layer thickness ≤5 mm on spiral CT) according to the efficacy evaluation criteria for solid tumors, RECIST version 1.1 (see Appendix 4, Criteria for Evaluating the Efficacy of Solid Tumor Treatments);
- Fresh or archived tumor tissue samples within 5 years are available for central laboratory testing during the screening period (if they are truly unavailable, this will not affect enrollment);
- ECOG physical status score of 0 to 2;
- treatment with other anti-tumor drugs (e.g., chemotherapy, hormone therapy, immunotherapy, antibody therapy, radiotherapy) prior to the first dose exceeds the 5 half-life of the drug or more than 4 weeks before the first dose (whichever is shorter);
- Organ function levels must meet the following requirements (no blood or blood product transfusion, hematopoietic stimulating factor, albumin, or blood product use within 14 days prior to the examination): absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelet count (PLT) ≥ 75 × 109/L, hemoglobin (Hb) ≥ 90 g/L; serum total bilirubin (TBIL) ≤ 1.5 Total bilirubin (TBIL) ≤1.5 times the upper limit of normal value, glutamic transaminase (AST) and alanine aminotransferase (ALT) ≤2.5 times the upper limit of normal value (if liver metastasis is present, total bilirubin ≤3 times the upper limit of normal value, AST and ALT ≤5 times the upper limit of normal value are allowed). 10;
- Pre-menopausal women of childbearing potential must undergo a pregnancy test within 7 days prior to the start of treatment, and the result of the pregnancy test must be negative and non-lactating; women without childbearing potential may not undergo a pregnancy test and contraception, provided they are over 50 years of age, have not used hormone therapy and have stopped menstruating for at least 12 months, or have been sterilized. All enrolled subjects (either male or female) should use adequate barrier contraception throughout the treatment period and for 3 months after completion of treatment.
- Other toxicity parameters must be NCI-CTCAE v.5.0 Grade 0 or 1.
Exclusion
- Subjects who require long-term systemic application of anti-allergic medications or who have a history of life-threatening allergic reactions to any vaccine or medication;
- those with symptomatic or rapidly progressing central system metastases. Presence of extensive pulmonary metastases causing respiratory distress; subjects with tumours in close proximity to or invading large blood vessels or nerves;
- new cerebrovascular accidents (including ischaemic stroke, haemorrhagic stroke and transient ischaemic attack) within 6 months prior to screening;
- acute myocardial infarction, uncontrolled angina pectoris, uncontrolled arrhythmia, severe heart failure (see Appendix 3, New York Heart Association's Heart Failure Classification Criteria, NYHA Class ≥ III) and other cardiovascular diseases within 6 months prior to screening;
- have received immunomodulatory medications within 4 weeks prior to the date of first vaccination (D1), including, but not limited to, IL-2, CTLA-4 inhibitors, CD40 agonists, CD137 agonists, and IFN-alpha (except for high-risk surgical subjects using IFN-alpha as an adjuvant therapy if IFN-alpha therapy was discontinued within the 4 weeks prior to the date of the trial);
- those with a history of renal insufficiency with serum creatinine levels greater than 1.5 times the upper limit of normal;
- have received a blood transfusion, erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF), or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 2 weeks prior to the first dose of drug;
- subjects with skin conditions that may prevent intradermal vaccine from reaching the target area (e.g., psoriasis);
- subjects in the Screening Period who continue to have adverse reactions from prior anti-neoplastic therapy that have not been restored to a CTCAE Version 5.0 grade rating of ≤ Grade 1 (with the exception of alopecia and platinum-induced neurotoxicity of ≤ Grade 2);
- need for concomitant use of steroidal hormonal medications (tumour or non-tumour related disease); exceptions may be made for those requiring topical (not applied to the vaccination site) or inhaled steroids;
- the presence of active or uncontrollable infections requiring systemic therapy (except for simple urinary tract infections or upper respiratory tract infections) in the subject within 4 weeks prior to screening; and the presence of antibodies to the Human Immunodeficiency Virus (HIV), hepatitis B Surface Antigen (SAB) positive and/or hepatitis B Core Antibody (HBCO) positive with Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) \>1000 copies/mL and Hepatitis C virus (HCV) antibodies on virological testing during the Screening Period, Subjects who are positive for antibodies specific to syphilis spirochetes;
- poorly controlled hypertension (defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg) after treatment;
- subjects with a history of autoimmune disease \[e.g., the following, but not limited to: interstitial pneumonitis, uveitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism (hypothyroidism without clinical symptoms or hypothyroidism due to radiotherapy may be included), subjects with vitiligo or cured asthma that does not currently require any intervention may be included, subjects requiring bronchodilators for medical intervention cannot be included\];
- subjects with active ulcers or gastrointestinal bleeding during the Screening Period;
- subjects who have received a previous similar therapeutic cancer vaccine or who have received another vaccine within 4 weeks prior to Screening;
- subjects with congenital or acquired immunodeficiency;
- subjects who have participated in other clinical trials within 1 month prior to screening;
- subjects with known alcohol or drug addiction;
- subjects who, in the opinion of the investigator, have an underlying health condition, mental condition, or social condition that makes the subject unable or unwilling to comply with the study protocol
- any other condition which, in the opinion of the Investigator, makes participation in this study inappropriate.
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05986981
Start Date
August 1 2023
End Date
December 1 2024
Last Update
August 14 2023
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730