advanced solid tumors
Conditions
Interventions
Group 1:PM1016 injection
Group 2:PM1016 injection
Sponsors
Shanghai Orient Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Volunteer to participate in clinical studies;Fully understand the study and voluntarily sign the informed consent;Willing to follow and able to complete all test procedures; 2.Male or female, aged 18 to 75 years (including boundary values); 3.Subjects with advanced malignant solid tumors proven histologically or cytologically; Stage I: Subjects with advanced malignant solid tumors who have failed standard treatment, or have no standard treatment options, or are not currently eligible for standard treatment; Stage IIa: subjects with specific tumor types who have failed standard treatment or are not eligible for standard treatment at this stage (the inclusion criteria associated with different tumor types will be listed separately in Appendix 1); 4.Remission of all toxic reactions from previous antitumor therapy to grade 0-1 (according to NCI CTCAE version 5.0) or to a level acceptable to inclusion/exclusion criteria. Other toxicity, such as alopecia, which the investigator considers does not pose a safety risk to the subjects; 5.Sufficient organ function (without medical support such as blood transfusion and granulocyte colony-stimulating factor within 14 days prior to study treatment initiation), defined as follows: (1)Blood system: absolute neutrophil count (ANC) >= 1.5 x 10^9/ L; Platelet count >= 75 x 10^9/ L; Hemoglobin >= 9g/dL or >= 5.6mmol/L. (2)Liver function: Total bilirubin = 50 mL/ min (calculation formula is shown in Appendix 2). (4)Internationally standardized ratios INR = 12 weeks; 8.According to RECIST 1.1 criteria, at least one measurable lesion exists and can meet the injection volume requirements of the current dose (it is recommended to consult the joint judgment of the doctors who perform tumor injection in the research center); In addition to the target injection tumor focus, there should be a measurable target non-injection tumor focus to observe the distal antitumor efficacy; 9.Serum or urine pregnancy test results of women of childbearing age are negative within 7 days before the first dose.Male and female patients of reproductive age must remain abstinent or use adequate contraception for 3 months from the date of signing the study informed consent until the last study drug treatment. Refer to 4.7 Contraceptive requirements for details.Male subjects did not donate sperm during the study period. An infertile woman is: Postmenopausal women: Natural amenorrhea for at least 12 months, excluding illness (such as anorexia nervosa), and no medication (such as oral contraceptives, hormones, gonadotropin-releasing hormone, anti-estrogens, selective estrogen receptor modulators or chemotherapy) that causes amenorrhea during amenorrhea; Natural amenorrhea for 6 to 12 months with follicle-stimulating hormone levels >40 mLU/mL. Documented irreversible sterilization, including hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, does not count as tubal ligation.
Exclusion criteria
Exclusion criteria: 1.A history of serious allergic diseases, a history of allergy to serious drugs (including unmarketed experimental drugs) or a known allergy to any component of this experimental drug; 2.Previous oncolytic virus therapy; 3.Previously received cell therapy or tumor vaccine; 4.Prior to the initiation of study treatment, the following treatments or medications were received: (1) Major surgery (defined as any invasive procedure with extensive excision, such as entry into a body cavity, removal of an organ, or normal anatomical changes, within 28 days prior to the commencement of study treatment;If the mesothelial cell barrier (e.g., pleural space, peritoneum, meninges) is opened, the procedure is considered major surgery.Surgery for the purpose of tissue biopsy, central venous catheter placement not considered major surgery) or unhealed wounds, ulcers, or fractures; (2) Received live attenuated vaccine within 28 days before the study began; (3) Received chemotherapy, radiotherapy, biotherapy, endocrine therapy, immunotherapy and other anti-tumor drugs within 28 days prior to the study, except for the following: Nitrosourea or mitomycin C within 6 weeks before study initiation; Oral fluorouracil and small molecule targeted drugs were administered 2 weeks before the study began or within 5 half-lives of the drug (whichever is longer); The traditional Chinese medicine with anti-tumor indications was used within 2 weeks before the first use of the study drug. (4) To research within 2 weeks before treatment, received corticosteroid or immunosuppressive drugs (such as cyclophosphamide, azathioprine, methotrexate, Sally degree amine, anti TNF alpha drugs), except in the case of the following a short period of time (7 days or less), prednisone dose not more than 10 mg/d or an equivalent dose of corticosteroid for prevention or treatment of non-self autoimmune condition;Topical, intranasal, intraocular, intraarticular or inhaled corticosteroids; 5.Patients with clinical symptoms of central nervous system metastases or meningeal metastases, or with other evidence that the central nervous system metastases or meningeal metastases are not under control, and are not suitable for inclusion in the study as judged by the investigator; 6.There is no active autoimmune disease, or a history of autoimmune disease recurrence and expectations (including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, autoimmune hepatitis, uveitis, enteritis, hepatitis, the pituitary gland inflammation, vasculitis, nephritis, thyroid function, thyroid function decrease, need bronchodilator asthmatic subjects of medical intervention. Except for the following: type 1 diabetes;Skin diseases that do not require general treatment (e.g. vitiligo, psoriasis, hair loss); Hypothyroidism only on hormone replacement therapy;Asthma that has been completely remitted in childhood does not require any intervention in adulthood; Or other conditions that are not expected to recur in the absence of external triggers); 7.Began to study five years before treatment, has been suffering from other active malignancy (only applicable to type IIa stage), but except for local treatment and cure of malignant tumor (such as basal cell or squamous cell carcinoma of the skin, superficial or non invasive bladder cancer, cervical carcinoma in situ, breast intraductal carcinoma in situ, thyroid papillary carcinoma, there is no evidence of prostate intraepithelial neoplasia and
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Types, frequency, severity and degree of adverse events (TEAE) during treatment;Results of clinically significant laboratory tests; Electrocardiogram (ECG); Echocardiography; Vital signs; Physical examination findings; ECOG physical condition score, etc;Determining the MTD and/or RP2D of PM1016 based on safety, tolerability, initial efficacy, and other available data; | — |
Countries
China
Contacts
Public ContactGuo Ye
Shanghai Orient Hospital
Outcome results
None listed