JPRN-jRCT2031210405招募中1 期
An Open-Label, Multicenter, Phase 1b/2 Study of E7386 in Combination With Pembrolizumab in Previously Treated Subjects With Selected Solid Tumors
Tamai Toshiyuki0 个研究点目标入组 108 人开始时间: 2021年11月1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
- 108
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Male or female, age >=18 years at the time of informed consent
- •2. Have a histologically or cytologically-documented, advanced (metastatic and/or unresectable) selected solid tumor for which prior standard systemic therapy has failed. Selected tumor types: melanoma (excluding uveal melanoma), CRC, HCC
- •3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •4. Must have disease progression on current or since the last anticancer treatment
- •5. At least one measurable lesion by computer tomography (CT) or magnetic imaging resonance (MRI) based on RECIST 1.1
- •6. Adequate organ function and serum mineral level per blood work
- •7. Melanoma cohort (Phase 2), participants must have:
- •- Unresectable Stage III or Stage IV melanoma, not amenable to local therapy.
- •- Received only 1 or, if known BRAF mut +ve, 2 lines of therapies prior to study enrollment and must have progressed on 1 prior BRAF inhibitor
- •8. CRC cohort (Phase 2), participants must have received at least 2 prior systemic therapies in adjuvant and/or metastatic setting (not exceeding 4 lines of therapies in the metastatic setting, progressed on at least 1 prior regimen in the metastatic setting or could not tolerate standard treatment)
- •9. HCC cohort (phase 2), participants must have:
- •- Barcelona Clinic Liver Cancer (BCLC) Stage B (not amenable for transarterial chemoembolization [TACE]) or Stage C and Child Pugh class A
- •- Has received only 1 prior line of systemic therapy in the locally advanced or metastatic setting, and must have progressed on treatment with an anti-PD-1/L1 monoclonal antibodies (mAb) administered either as monotherapy, or in combination
排除标准
- •1. Prior treatment with E7386 or prior therapy with anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (example, CTLA-4, OX 40, CD137) that was discontinued due to a Grade 3 or higher immune-related (ir)AE
- •2. Participants with brain or subdural metastases, unless they have completed local therapy and have discontinued the use of
- •corticosteroids for this indication for at least 4 weeks before starting treatment in this study
- •3. Any active infection requiring systemic treatment
- •4. Has severe hypersensitivity to study drugs and/or any of its excipients
- •5. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
- •6. Has an active autoimmune disease that has required systemic treatment in the past 2 years
- •7. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
- •8. Any bone disease/conditions as follows:
- •- Osteoporosis with T-score <-2.5 by DXA scan
- •- Metabolic bone disease, such as hyperparathyroidism, Paget's disease or osteomalacia
- •- Symptomatic hypercalcemia requiring bisphosphonate therapy
- •- History of any fracture within 6 months prior to starting study drug
- •- History of symptomatic vertebral fragility fracture or any fragility fracture
- •- Moderate or severe morphometric vertebral fracture at baseline.
- •- Any condition requiring orthopedic intervention.
- •- Bone metastases not being treated with a bisphosphonate or denosumab
- •9. Active viral hepatitis (B or C) as demonstrated by positive serology for participants with melanoma and CRC. Dual active hepatitis B virus (HBV) infection and hepatitis C virus (HCV) infection at study entry for participants with HCC
- •10. Known to be human immunodeficiency virus (HIV) positive
- •11. Received blood/platelet transfusion or G-CSF within 4 weeks before study entry
- •12. For Melanoma only, participants with ocular melanoma are excluded
- •13. For CRC only, participants are excluded if:
- •- has a tumor that is microsatellite instability high (MSI H)/ DNA mismatch repair-deficient (dMMR) positive
- •- has received prior treatment with anti-PD-1, anti-PD-L1, or anti-PDL2 agent
- •14. For HCC only, participants are excluded if:
- •- clear invasion to bile duct or portal vein invasion of Vp4
- •- symptomatic gastric or esophageal varices per Investigator's clinical judgement
- •- history of hepatic encephalopathy within 6 months prior to starting study drug
研究者
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