ACTRN12620000440921终止1 期
Phase 1, Multicenter, First-in-Human Dose Escalation Study of ALMB-0168 Administered IV as a Single Agent to Patients with Malignant Bone Disease
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 2
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 16 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Pathological confirmation (histological or cytological) of cancer: Osteosarcoma or any other solid tumour cancer.
- •2. Presence of either:
- •a. Locally advanced or relapsed osteosarcoma considered to be incurable by the investigator and for which there is no available therapies;
- •b. Advanced solid tumour with bone metastatic cancer considered to be incurable by the investigator and for which available anti-cancer therapy has been exhausted, refused or not tolerated. Breast Cancer (BC) or Prostate Cancer (PC) subjects with bone metastases and who have been under hormonal therapy as Standard of Care (SOC) for underling cancer for at least 3 months and with stable dose and clinical status maybe allowed to enrol. The same applies to SOC bisphosphonates and denosumab, which are also allowable if the subject has been receiving this treatment for a period of at least 3 months at a stable dose prior to screening.
- •3. Male or female 16 years of age or older for subjects with osteosarcoma, or 18 years or older for subjects with all other tumour types.
- •4. ECOG (Eastern Cooperative Oncology Group) performance status (PS) of 0, 1 or 2
- •5. Either measurable or non-measurable disease. Non-measurable disease should be assessable by conventional imaging techniques including isotope bone scans, CT or MRI
- •6. Adequate major system function defined as:
- •a. Bone marrow reserve: Absolute neutrophil count (ANC) greater than or equal to 1.5 x109/L; Platelet count greater than or equal to 100 x 109/L; Haemoglobin greater than or equal to 90 g/L
- •b. Hepatic function: Total bilirubin lesser than or equal to1.5 x upper limit of normal (ULN) Transaminases (aspartate aminotransferase/serum glutamic oxaloacetic transaminase-AST/SGOT and/or alanine aminotransferase/serum glutamic pyruvic transaminase-ALT/SGPT) lesser than or equal to 3 x ULN (lesser than 5 x ULN if liver metastases);
- •c. Renal function: Normal serum creatinine lesser than or equal to 1.5 mg/dL (133 µmol/L) OR calculated creatinine clearance greater than or equal to 50 mL/min.
- •d. Coagulation: Adequate coagulation parameters defined as International Normalization Ratio (INR) lesser than or equal to 2.
- •7. Male participants with female partners of childbearing potential and women participants of
- •childbearing potential are required to use two forms of acceptable contraception, including 1 barrier method, during their participation in the study and for 30 days following last dose. Male subjects must also refrain from donating sperm during their participation in the study.
- •8. Life expectancy greater than or equal to 3 months.
- •9. Willingness and ability to comply with study and follow-up procedures.
- •10. Ability to understand the nature of this study and give written informed consent.
排除标准
- •1. Most recent chemotherapy lesser than or equal to14 days or have residual NCI CTCAE greater than or equal to Grade 1 chemotherapy-related side effects, with the exception of alopecia.
- •2. Use of any experimental study drug lesser than or equal to 21 days or 5 half-lives (whichever is shorter) prior to the first dose of ALMB-0168. For study drugs for which 5 half-lives is lesser than or equal to 21 days such as tyrosine kinase inhibitor (TKI), a minimum of 10 days between termination of the study drug and administration of ALMB-0168 is required. For certain immune-oncology drugs that have longer half-lives, a washout period of 4 weeks may be required.
- •3. Wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) administered lesser than or equal to 28 days or limited field radiation for palliation lesser than or equal to 7 days prior to starting study drug or has not recovered from side effects of such therapy.
- •4. Major surgical procedures lesser than or equal to 28 days of beginning study drug, or minor surgical procedures lesser than or equal to 7 days. No waiting required following port-a-cath placement.
- •5. Brain metastases or CNS injuries / abnormalities by history or as determined by brain MRI.
- •6. Leptomeningeal metastases or spinal cord compression due to disease.
- •7. Pregnant or lactating.
- •8. Any of the following cardiac diseases currently or within the last 6 months:
- •- Left ventricular ejection fraction (LVEF) lesser than 45% as determined by multiple gated
- •acquisition (MUGA) scan or echocardiogram (ECHO);
- •- QTc interval greater than 470 msec for females and greater than 450 msec for men on screening electrocardiogram (ECG);
- •- Unstable angina pectoris;
- •- New York Heart Association Class III or IV heart failure, acute myocardial infarction, angina pectoris, uncontrolled arrhythmia, acute coronary syndromes, stent placement, uncontrolled hypertension
- •9. Serious active infection at the time of treatment (no systemic intravenous antibiotics within 14 days; oral antibiotics is allowed), or another serious underlying medical condition that would impair the ability of the subject to receive protocol treatment.
- •10. Known diagnosis of human immunodeficiency virus, hepatitis B, or hepatitis C.
- •11. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin
- •that has undergone potentially curative therapy or in situ cervical cancer
- •12. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
- •13. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject’s participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating Investigator.
研究者
相似试验
招募中
1 期
A trial to assess the safety and tolerability of EBC-1013 Gel in participants with venous leg ulcers.Venous Leg UlcersSkin - Dermatological conditionsSkin - Other skin conditionsACTRN12624000544572QBiotics Group Limited35
招募中
不适用
A Phase I/IIa (dose-escalation, single-center, open-label, Phase I and randomized, observer-blind, multi-center, placebo-controlled, Phase IIa) study to determine safety, tolerance and immunogenicity of a preventive COVID-19 vaccine ‘mRNA SARS-CoV-2 Vaccine (EG-COVID)’ in healthy adultKCT0006670Eyegene45
招募中
不适用
First-in-human Phase I dose escalation study assessing safety, tolerability and preliminary efficacy of immunomodulatory nanoparticlesNL-OMON52685Tumor Immunology15
进行中（未招募）
1 期
A first-in-human study to investigate the safety and tolerability of a new antibody-guided drug delivery treatment for patients with therapy resistant ovarian or lung cancer.Platinum-resistant high-grade ovarian cancer (PROC) or relapsed/refractory adenocarcinoma non-small cell lung cancer (NSCLC)CTIS2024-511074-80-01Tubulis GmbH140
招募中
2 期
Phase I/II, First in Human, Dose Escalation Trial of TL-895 Monotherapy in Subjects with Relapsed/Refractory B-Cell Malignancies and Expansion of TL-895 Monotherapy and Combination Therapy with Navtemadlin in Treatment-Naïve Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Subjects and Subjects with Relapsed/Refractory Chronic Lymphocytic Leukemia or Relapsed/Refractory Small Lymphocytic Lymphoma2024-516691-14-00Telios Pharma Inc.69