NCT06940739招募中1 期
A Phase 1/2, Open-label Study of a Modified Interleukin-2 Fusion Protein (IOV-3001) in Participants With Previously Treated, Unresectable or Metastatic Melanoma Who Will Receive Lifileucel
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 4
- 主要终点
- Safety and Tolerability
研究概览
简要总结
A Phase 1/2, open-label study of a modified interleukin-2 fusion protein (IOV 3001) in participants with previously treated, unresectable or metastatic melanoma who will receive lifileucel.
详细描述
This study is the first-in-human (FIH) study of IOV-3001. IOV-3001 is an antibody interleukin-2 (IL-2) fusion protein in which a modified form of aldesleukin is incorporated into the antibody palivizumab.
The Phase 1 portion will include 2 parts. Participants will receive IOV-3001 either before the Lifileucel regimen (Part 1) or after Lifileucel instead of aldesleukin (Part 2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must be ≥ 18 years of age at the time of signing the informed consent.
- •Participant has unresectable or metastatic melanoma.
- •Participant has melanoma not of uveal/ocular origin and experienced documented radiographic disease progression during systemic therapy with a PD-1/PD-L1 blocking antibody or within 12 weeks after the last dose of the PD-1/PD-L1 blocking antibody. If the tumor is BRAF V600 mutation positive, the participant also received or refused a BRAF inhibitor with or without a MEK inhibitor.
- •OR Phase 1, Part 1 only: For participants with uveal melanoma, tebentafusp must have been received if available as standard of care (human leukocyte antigen [HLA]-A*02:01 positive participant and approved by local authorities for uveal melanoma) or refused.
- •Participant has an ECOG performance status of 0 or 1 and, in the investigator's opinion, an estimated life expectancy of > 6 months.
- •Phase 1, Part 2 only: Following tumor resection for lifileucel generation, the participant will have at least one remaining measurable lesion, as defined by RECIST v1.
- •Participant has recovered from all prior anticancer treatment-related AEs
排除标准
- •Participant has symptomatic untreated brain metastases.
- •Participant is at an increased risk for systemic infections; seizure disorders; coagulation disorders; or other active major medical illnesses of the cardiovascular, respiratory, or immune systems.
- •Participant has active uveitis that requires active treatment.
- •Participant has any form of primary immunodeficiency (e.g., severe combined immunodeficiency disease [SCID] or AIDS).
- •Participant has a history of hypersensitivity to any component of the study intervention.
- •Participant had another primary malignancy within the previous 3 years.
- •Participants who require systemic steroid therapy 10 mg/day prednisone or another steroid equivalent dose.
- •Participants who have had a history of allogeneic organ transplant or any form of cell therapy involving prior conditioning chemotherapy within the past 20 years.
研究组 & 干预措施
Assigned Interventions
Experimental
Dose escalation participants with unresectable or metastatic melanoma
干预措施: IOV-3001 (Biological)
结局指标
主要结局
Safety and Tolerability
时间窗: Up to 30 days
The frequency and severity of treatment emergent adverse events and serious adverse events will be assessed when IOV-3001 administered
Recommended Dose for Phase 2
时间窗: Up to 30 days
Determine the recommended dose for Phase 2
次要结局
- Pharmacokinetics (PK) profile of IOV-3001(Up to 8 days)
- Pharmacodynamic (PD) Profile of IOV-3001(Up to 8 days)
- Antidrug Antibody (ADA) Profile(Up to 5 years)
- Overall Response Rate (ORR)(Up to 5 years)
- Complete Response (CR) rate(Up to 5 years)
- Duration of Response (DOR)(Up to 5 years)
- Disease Control Rate (DCR)(Up to 5 years)
- Progression-Free Survival (PFS)(Up to 5 years)
- Overall Survival (OS)(Up to 5 years)
- In vivo persistence of Lifileucel(Up to 5 years)
研究者
研究点 (4)
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