EUCTR2019-003456-36-ES进行中（未招募）1 期
A first in human Phase 1/2 open-label, multicenter, dose escalation and expansion study of PRS-344/S095012 in patients with solid tumors
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 161
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. Age =18 years on the day the consent is signed.
- •2. Dose escalation and back-fill cohorts: Patients with histologically confirmed diagnosis of unresectable, locally advanced or metastatic solid tumor for which standard treatment options are not available, no longer effective, or not tolerated.
- •3. Patient should have a documented disease progression on prior therapy before entry into this study.
- •4. Patients must have at least one measurable target lesion as per RECIST 1.1
- •5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •6. Patient with no available archived material must have one or more tumor lesions amenable to biopsy.
- •7. Adequate organ function as assessed by laboratory tests within 72 hours prior to the start of treatment.
- •Dose Expansion:
- •8. Patients who have had prior checkpoint inhibitor (CPI) treatment in the past 6 months must have documented confirmed radiographic progression from it prior to study entry.
- •9. Patients with histologically diagnosed extensive stage small cell lung cancer or locally advanced or metastatic squamous cell carcinoma of the esophagus.
- •10. Patients must have received and progressed on only one prior regimen in the metastatic setting comprising an PD-(L)1 plus chemotherapy.
- •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 110
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 51
排除标准
- •1. Patients with previously treated brain metastases may participate provided they are radiologically stable, clinically asymptomatic and are off immunosuppressive therapies for at least 4 weeks. Low dose of steroid<10 mg/day prednisone or equivalent) is allowed
- •2. Patients who have received prior:
- •a. Small molecule inhibitors, and/or other similar investigational agent: = 2 weeks or 5 half-lives, whichever is shorter.
- •b. Chemotherapy, other monoclonal antibodies, antibody-drug conjugates, or other similar experimental therapies: = 3 weeks or 5 half-lives, whichever is shorter.
- •c. Radioimmunoconjugates or other similar experimental therapies = 6 weeks or 5 half-lives, whichever is shorter.
- •3. Patients who have received 4-1BB agonists in the past.
- •4. Patients who had a major surgery within 4 weeks prior to first administration of IMP.
- •Dose Expansion:
- •5. Patient who received therapy with an irinotecan containing regimen
- •6. Patients must not be on warfarin, strong cytochrome P450 (CYP) 3A4 inducers, strong CYP3A4 inhibitors, or strong UGT1A1 inhibitors.
研究者
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