advanced solid tumor
Conditions
Interventions
Experimental group:PM1015 injection
Sponsors
BEIJING CANCER HOSPITAL
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Volunteer to participate in clinical trials; Fully understand the test and voluntarily sign the informed consent; Willing to follow and able to complete all test procedures; 2. No gender limit, aged between 18 and 75 years (including boundary values); 3. Subjects with histologically or cytologically confirmed advanced malignant solid tumors who have failed standard treatment, have no standard treatment options, or are not currently eligible for standard treatment; 4. Adequate organ function, as defined below: (1) Blood system (in the absence of blood transfusion, granulocyte colony stimulating factor, or other medical support within 14 days prior to initiation of trial therapy) : neutrophil count (ANC) >= 1.5 x 10^9 /L; Platelet count (PLT) >= 100 x 10^9 /L; Hemoglobin (Hb) >= 90 g/L; (2) Liver function: total bilirubin (TBIL) = 50 mL/min (Cockcroft-Gault formula: [(140 - age) x body weight (kg) x 0.85 (for females only)] / [72 x creatinine (mg/dL)]; (Creatinine unit conversion: 1 mg/dL = 88.4 µmol/L); Qualitative urine protein = 2+, 24h urine protein quantitative examination is required; if the quantitative urine protein = 12 weeks; 7. Dose escalation test: According to RECIST version 1.1, there is at least one evaluable tumor lesion; Initial dose extension test: At least one measurable tumor lesion according to RECIST version 1.1; (Tumor lesions located in the area of previous radiotherapy or other local regional treatment sites are generally not considered as measurable lesions, unless the lesions show definite progression or persist 3 months after radiotherapy; Not accept only bone metastases or only central nervous system metastases as measurable lesions); 8. All subjects should undergo a fresh tumor lesion biopsy during the screening period (No bone biopsy; Biopsy is also not acceptable in subjects with a single target lesion for biopsy); If biopsy is not possible, subjects should provide formalin-fixed-paraffin-embedded (FFPE) tumor samples from the nearest (up to 24 months) to the start of the trial for biomarker analysis; If the subject is unable to provide specimens that meet the above requirements due to special reasons, the subject may participate in screening with the consent of the sponsor's medical monitor; 9. A fertile female subject has a negative serum-pregnancy result within 7 days prior to the start of the trial treatment and is willing to abstain from sex or use a medically approved highly effective contraceptive method (e.g. IUD, condom) from the date of signing the informed consent to 6 months after the end of the final medication; 10. Male subjects are willing to abstain from sex or use a medically approved highly effective contraceptive method for 6 mont
Exclusion criteria
Exclusion criteria: 1. History of severe allergic disease, allergy to serious drugs (including unmarketed test drugs) or known allergy to any component of the test drug; 2. Previous treatment with adenosine inhibitors (such as anti-CD73, anti-CD39, or anti-A2aR); 3. Received an unmarketed investigational drug or treatment within 4 weeks prior to initiation of the trial treatment, or is still within the drug's 5 half-lives (if known), whichever is longer; 4. The adverse reactions of previous antitumor therapy have not recovered to the NCI-CTCAE V5.0 rating 10 mg/ day or equivalent dose of the same drug) or other immunosuppressant therapy within 14 days prior to the initial use of the test drug; Except in the following cases: treatment with topical, ocular, intra-articular, intranasal, and inhaled corticosteroids; Short-term use of glucocorticoids for preventive treatment (e.g. to prevent hypersensitivity to contrast media); (4) Have received live attenuated vaccine within 4 weeks before the first use of the trial drug; 6. History of immune deficiency, including HIV antibody positive test; 7. Syphilis antibody positive; 8. HBsAg or HBcAb positive, HBV-DNA > 500 IU/mL or lower limit of detection in test center (only when lower limit of detection in test center is higher than 500 IU/mL); HCV antibody positive and HCV-RNA higher than the lower limit of test center detection; 9. Subjects with brain parenchymal metastasis or meningeal metastasis with clinical symptoms were judged by the researchers to be unsuitable for inclusion; 10. Active infection; 11. Subjects with active or previous autoimmune diseases with potential recurrence (e.g. systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.), except clinically stable autoimmune thyroid disease and type I diabetes; 12. Currently with uncontrollable pleural, pericardial and abdominal effusion; 13. A history of severe cardiovascular and cerebrovascular diseases, including but not limited to: (1) Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, degree ?-? atrioventricular block; (2) The mean QT interval (QTcF) corrected by Fri
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of dose-limiting toxicity (DLT) within 21 days of initial administration;Incidence and severity of treatment-related adverse events (TRAE) in all dose groups; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR);PM1015 anti-drug antibody;Maximum tolerated dose (MTD) of PM1015;Combined dose and frequency of PM1015 phase II clinical trial;Pharmacokinetic characteristic;Disease control rate (DCR);Progression-free survival (PFS);Overall survival (OS); | — |
Countries
China
Contacts
Public ContactShen Lin
Outcome results
None listed