Osteosarcoma
Conditions
Interventions
Experimental Group:ALMB-0168
Sponsors
The First Affiliated Hospital, Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Histopathologically confirmed osteosarcoma; 2.Patients will be enrolled according to different stages: (1)Patients with osteosarcoma whose prior standard treatment have failed; (2)Patients with high-grade osteosarcoma whose prior standard treatment have failed; 3.16 years of age or older, male or female; 4.Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2; 5.Either measurable or non-measurable disease per RECIST v1.1. Non-measurable disease should be assessable by conventional imaging techniques including isotope bone scans, CT or MRI scans. Patients in part II stage must have at least one measurable lesion confirmed by CT or MRI at baseline; 6.Adequate major system function defined as: (1) Bone marrow reserve: Absolute neutrophil count (ANC) >=1.5 x10^9/L; Platelet count >= 75 x 10^9/L; Hemoglobin >= 90 g/L (not receiving blood transfusion within 14 days before the first administration); (2) Hepatic function: Total bilirubin =50 mL/min. (Cockcroft - Gault formula); (4) Coagulation: Adequate coagulation parameters defined as International Normalization Ratio (INR) =3 months; 9.Ability to understand the entire process of this study, voluntarily participate and sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1.Any recent anti-tumour therapy 470 msec for females and > 450 msec for men in electrocardiogram (ECG) at screening; (3) Unstable angina pectoris; (4) Heart failure (New York Heart Association (NYHA) >2 grade); (5) Acute myocardial infarction; (6) Uncontrolled arrhythmia; (7) Acute coronary syndromes; (8) Stent placement. 8.Uncontrolled hypertension (systolic blood pressure (SBP) > 160 mmHg or diastolic blood pressure (DBP) > 100 mmHg (Patients with blood pressure values higher than these levels must use drugs to control blood pressure below this level before the first dose of study drug)); 9.Have a serious active infection (systemic intravenous antibiotics within 14 days but oral antibiotics allowed) that is not well controlled, or have another serious underlying medical condition that would prevent the patients from receiving the protocol treatment; 10.Known diagnosis of human immunodeficiency virus, active hepatitis B or C; 11.Have received Chinese herbal medicine or Chinese patent drug with anti-tumor activity within 14 days before the first administration; 12.Has other active tumors or a history of infiltrative tumor treatment within 3 years. Patients with a history of definitively locally treated stage I tumors who are considered unlikely to recur can be accepted. Patients with a history of prior treatment for carcinoma in situ (e.g., non-invasive) and history of non-melanoma skin cancer are acceptable; 13.According to the researchers' judgment, patients with other factors that may lead to the termination of the study, such as other serious diseases (including severe mental disorders) requiring combined treatment, serious laboratory abnormalities, family or social factors, which may affect the safety or the collection of data and samples. Psychological, family, social or geographical conditions and other factors are not consistent with the experimental schem.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| adverse reaction;Dose-Limited Toxicities (DLT);6-month progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR);Disease control rate (DCR);Disease control rate (DCR);Progression-free survival (PFS);ime to Response (TTR);Overall survival (OS);Skeletal Related Events (SRE);alkaline phosphatase (ALP) and lactate dehydrogenase (LDH);numeric pain scale (NRS) and quality of life scale (EQ-5D) scores;Bone Mineral Density (BMD);Dose and frequency of morphine;Pharmacokinetics;The incidence of anti-drug antibody (ADA); | — |
Countries
China
Contacts
Public ContactShen Jingnan
Outcome results
None listed