A Phase 1b, Dose Escalation/Dose Expansion, Multicenter, Open-Label Study to Assess the Safety and Tolerability of OPN-6602 Monotherapy and in Combination With Dexamethasone in Subjects With Relapsed and/or Refractory Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Opna Bio LLC
- 入组人数
- 130
- 试验地点
- 22
- 主要终点
- Number and type of dose-limiting toxicities (DLTs)
研究概览
简要总结
Phase 1b, open-label study evaluating the safety, tolerability, pharmacokinetics, preliminary antitumor activity, and pharmacodynamics of OPN-6602 monotherapy and in combination with dexamethasone in subjects with relapsed and/or refractory MM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of multiple myeloma (MM)
- •Relapsed or refractory to 3 or more different prior lines of therapy for MM that included immunomodulatory agents, proteosome inhibitors, and anti-CD38 antibody and not a candidate for or intolerant to established therapy known to provide clinical benefit
- •Adequate hematologic, renal, liver, cardiac function
排除标准
- •Monoclonal gammopathy of undetermined significance (MGUS), smoldering myeloma, Waldenström's macroglobulinemia, or IgM myeloma
- •Active plasma cell leukemia
- •Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes (POEMS syndrome)
- •Prior Stevens Johnson syndrome
- •Localized radiation therapy to disease site(s) within 2 weeks of the first dose
- •Prior autologous peripheral stem cell transplant or prior autologous bone marrow transplantation within <90 days of the first dose of study drug
- •Prior allogeneic stem cell transplantation or solid organ transplantation within 12 months of first dose of study drug; subjects receiving immunosuppressive medication for active graft vs host disease will be excluded.
- •Prior chemotherapy, targeted anticancer or radiation therapy within 2 weeks prior to first dose of study drug
- •Concomitant high-dose corticosteroids (except subjects on chronic steroids given for disorders other than myeloma)
- •Known central nervous system involvement by multiple myeloma
- •Active known second malignancy with exception of adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or in situ cervical cancer; adequately treated Stage 1 cancer from which the subject is currently in remission and has been in remission for ≥2 years; low-risk prostate cancer with a Gleason score <7 and a PSA level <10 ng/mL; any other cancer from which the subject has been disease-free for ≥3 years
- •Ongoing systemic infection requiring parenteral treatment
- •Poorly controlled Type 2 diabetes
研究组 & 干预措施
Dose expansion
干预措施: OPN-6602 (Drug)
Dose escalation monotherapy
干预措施: OPN-6602 (Drug)
Dose escalation in combo with dexamethasone
干预措施: OPN-6602 (Drug)
Dose escalation in combo with dexamethasone
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Number and type of dose-limiting toxicities (DLTs)
时间窗: Through up to approximately 30 days following last dose of OPN-6602
Number and type of treatment-emergent adverse events (TEAEs)
时间窗: Through up to approximately 30 days following last dose of OPN-6602
Number of Participants With Clinical Laboratory Test Abnormalities
时间窗: Through up to approximately 30 days following last dose of OPN-6602
Number of participants who experienced a clinical laboratory test abnormality, including hematology and serum chemistry, and coagulation. Abnormalities considered are those Grade 3-4 events with a \>= 1 grade increase from baseline using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
次要结局
未报告次要终点