ACTRN12622001339741招募中1 期
A Phase I, Open-label, Multicenter, First in Human Study to Evaluate the Safety and Tolerability of HH3806 in Patients with Advanced Malignancies
Tigermed Australia Pty Ltd0 个研究点目标入组 36 人开始时间: 2022年10月18日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 36
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
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Male and female patients 18years of age or older .
- •2. Provide informed consent voluntarily prior to initiation of any study-related procedures.
- •3. Tumor type criteria: Histologically or cytologically confirmed diagnosis of one of the following advanced malignancy:
- •a) Solid tumors that meet the following criteria:
- •- Measurable disease by RECIST v1.1 in at least 1 site with the exception of Castration-Resistant Prostate Cancer (CRPC), who may be enrolled with objective evidence of disease as per certain criteria; disease progression with the last line of therapy and at least one prior standard of care regimens, or for which there is no approved therapy, or for which standard therapy is unsuitable or refused. Patients must have disease not amenable to surgery, radiation, or combined modality therapy with curative intent. Patients without treatment options available known to provide clinical benefit are also eligible
- •b) Relapsed/refractory NHL must have received at least 2 prior systemic therapies and there is no standard salvage regimen available.
- •4. Life expectancy greater than or equal to 3 months.
- •5. ECOG performance status less than or equal to 1.
- •6. Patient must have adequate organ function measured within 28 days of screening.
排除标准
- •Patients are ineligible for this study if they meet any of the following criteria:
- •1. Anticancer therapy (including chemotherapy, targeted therapy, biotherapy, hormone therapy, traditional Chinese medication with cancer indication or other investigational agents) within 4 weeks or 5 times of half-lives (whichever is shorter) prior to the first dose of the study drug.
- •2. Patients who had prior treatment with any BET inhibitor.
- •3. Radical radiation therapy within 4 weeks prior to the first dose of the investigational product or received local palliative radiation therapy for bone metastases within 2 weeks.
- •4. Any toxicities from prior treatment that have not recovered to baseline or less than or equal to NCI-CTCAE v5.0 Grade 1 before the start of study treatment, except for Adverse Events not considered a likely safety risk.
- •5. Patients who have been treated with any hematopoietic colony-stimulating growth factors 2 weeks prior to starting study drug.
- •6. Patients who have symptomatic CNS metastasis which is neurologically unstable or those who have CNS disease requiring increase in the dose of steroid. (Note: Patients with controlled CNS metastasis can participate in the trial. Before entering the study, patients should have finished radiotherapy, or have received operation for CNS tumor metastasis at least two weeks before. Patients’ neurological function must be in a stable state; no new neurological deficit is found during clinical examination and no new abnormality is found during CNS imaging examinations. If patients need to use steroids to treat CNS metastasis, the therapeutic dose of steroid should be stable for 3 months at least two weeks prior to entering the study with treatment dose no more than dexamethasone 4 mg daily or an equivalent dose of steroids).
- •7. Major surgery or had significant traumatic injury within 28 days prior to the first dose of the investigational product or has not recovered from major side effects.
- •8. Patients with prior immunodeficiency, or organ transplantation or patients after allogeneic stem cell transplantation if they are less than 100 days has elapsed from the day of transplantation, they are on any treatment for graft-versus-host disease, or they have not been off calcineurin inhibitors for at least 4 weeks are excluded.
- •9. Patients diagnosed with cataract who have not undergone surgery and do not meet either of the following conditions: best corrected visual acuity greater than or equal to 0.6, Postmydriatic LOCS III lens opacity classification criteria: posterior subcapsular (P) = 0, cortex (C) less than or equal to 2, nuclear (N) less than or equal to 2.
- •10. Known HIV.
- •11. Active hepatitis B and hepatitis C.
- •12. Patients with clinically significant cardiovascular disease.
- •13. Any active malignancy 2 years before the first dose of study drugs, except for the specific cancer under investigation and any locally recurring cancer that has been treated with curative intent.
- •14. Any condition that required systemic treatment with either corticosteroids or other immunosuppressive medication 14 days before the first dose of study drugs.
- •15. Unable or unwilling to swallow study medication or gastrointestinal condition which could impair absorption of study medication.
- •16. Patient has any other concurrent severe and/or uncontrolled medical condition such as active infection, unresolved bowel obstruction, or psychiatric disorders that would, in the investigator’s judgment, contraindica
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