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
概览
- 阶段
- 1 期
- 干预措施
- OPN-6602
- 疾病 / 适应症
- Relapsed Multiple Myeloma
- 发起方
- Opna Bio LLC
- 入组人数
- 130
- 试验地点
- 21
- 主要终点
- Number and type of dose-limiting toxicities (DLTs)
- 状态
- 招募中
- 最后更新
- 19天前
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.
研究者
入排标准
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
研究组 & 干预措施
Dose escalation monotherapy
干预措施: OPN-6602
Dose escalation in combo with dexamethasone
干预措施: OPN-6602
Dose escalation in combo with dexamethasone
干预措施: Dexamethasone
Dose expansion
干预措施: OPN-6602
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.