EUCTR2021-003569-36-ES进行中（未招募）1 期
A Phase I/II Open-label, Multi-center Study to Assess Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AZD7789, an Anti-PD-1 and Anti-TIM-3 Bispecific Antibody, in Patients with Relapsed or Refractory Classical Hodgkin Lymphoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Must be >= 18 years of age at the time of obtaining informed consent
- •2. Eastern Cooperative Oncology Group performance status of 0 or 1 at screening
- •3. Must have at least one PET-avid measurable lesion according to Modified Lugano Criteria
- •4. Confirmed histological diagnosis of active relapse/refractory cHL
- •5. Must have failed at least 2 prior lines of systemic therapy. In part A dose escalation and part B dose expansion cohort B1, the prior lines of therapy must include at least 3 cycles of an anti-PD-1/PD-L1 therapy. In part B dose expansion cohort B2, prior anti-PD-1/PD-L1 therapy is excluded. For all participants, no previous treatment with anti-TIM-3 is allowed. Previous anti-CTLA-4 treatment is acceptable with at least 2 months washout period prior to study entry
- •6. Adequate organ and bone marrow function measured within 7 days prior to first dose
- •7. Non-pregnant women and willingness of female participants to avoid pregnancy or male participants willing to avoid fathering children through highly effective methods of contraception
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 144
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 36
排除标准
- •1. Unresolved toxicities of >= Grade 2 from prior therapy
- •2. Any prior >= Grade 3 imAE while receiving immunotherapy
- •3. Participants with CNS involvement or leptomeningeal disease.
- •4. History of organ transplantation (e.g., stem cell or solid organ transplant).
- •5. Any venous or arterial thromboembolic event within <= 6 months prior to the first dose of study intervention.
- •6. Infectious disease exclusions: Active infection including TB, HIV, hepatitis A, chronic or active hepatitis B, chronic or active hepatitis C, active COVID-19 infection
- •7. History of arrhythmia which is requires treatment; symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia
- •8. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, cardiomyopathy of any etiology, symptomatic congestive heart failure, uncontrolled hypertension, uncontrolled diabetes mellitus, unstable angina pectoris, history of myocardial infarction within the past 6 months, serious chronic gastrointestinal conditions associated with diarrhea, active non-infectious skin disease
- •9. Active or prior documented autoimmune or inflammatory disorders, including inflammatory bowel disease (eg, colitis or Crohn's disease), diverticulitis (with the exception of diverticulosis), systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome (granulomatosis with polyangiitis), Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.. Some exceptions have been specified in the protocol
- •10. Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis requiring steroid treatment, or any evidence of clinically active ILD
- •11. Other invasive malignancy within 2 years prior to screening
- •12. Congenital long QT syndrome or history of QT prolongation associated with other medications that cannot be changed or discontinued based on a cardiologist assessment
- •13. Current or prior use of immunosuppressive medication within 14 days prior to the first dose of study intervention
- •14. Any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for noncancer-related conditions is acceptable.
研究者
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