NCT04798586Unknown1 期
A PHASE I, OPEN LABEL STUDY TO EVALUATE THE SAFETY AND PHARMACOKINETIC OF PF 06863135, A B CELL MATURATION ANTIGEN (BCMA) CD3 BISPECIFIC ANTIBODY, AS A SINGLE AGENT IN JAPANESE PARTICIPANTS WITH RELAPSED/REFRACTORY ADVANCED MULTIPLE MYELOMA
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- Pfizer
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Number of Participants With Dose Limiting Toxicities (DLTs)
研究概览
简要总结
The purpose of this study is to confirm the safety and tolerability of elranatamab (PF-06863135) in Japanese participants with relapsed or refractory MM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of multiple myeloma (IMWG criteria)
- •Measurable disease, as defined by at least 1 of the following
- •Serum myeloma (M) protein ≥0.5 g/dL (5 g/L)
- •Urine M protein ≥200 mg/24 h
- •Serum free light chain (FLC) >100 mg/L (10 mg/dL) with abnormal kappa:lambda ratio
- •Participants must have progressed on or been intolerant of at least 3 prior therapies including proteasome inhibitor, IMID drug and anti-CD38 antibody, either in combination or as a single agent
- •ECOG PS 0, 1 or
- •PS 3 is permitted if PS is due solely to bone pain
- •Adequate bone marrow, hematological, kidney and liver function
- •Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade 1
- •Not pregnant and willing to use contraception
排除标准
- •POEMS syndrome
- •Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
- •History of active autoimmune disorders
- •Any form of primary immunodeficiency
- •History of severe immune-mediated adverse event with prior immunomodulatory treatment
- •Stem cell transplant within 12 weeks prior to enrollment
- •Active graft versus host disease other than Grade 1 skin involvement, or that requiring immunosuppressive treatment
- •Requirement for systemic immune suppressive medication
- •Active, uncontrolled bacterial, fungal, or viral infection, including HBV, HCV, known HIV or AIDS related illness and SARS-CoV2
- •Previous administration with an investigational drug within 4 weeks or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer)
- •Known or suspected hypersensitivity to component of elranatamab (PF-06863135), murine and bovine products
- •Live attenuated vaccine within 4 weeks
研究组 & 干预措施
Elranatamab (PF-06863135)
Experimental
BCMA-CD3 bispecific antibody
干预措施: Elranatamab (PF-06863135) (Drug)
结局指标
主要结局
Number of Participants With Dose Limiting Toxicities (DLTs)
时间窗: Up to 4 weeks
DLT was defined as any of the following: Treatment Emergent Adverse Events (AEs) occurring in Cycle 0 and Cycle 1 (total 4 weeks): Grade (G) 4 neutropenia lasting greater than (\>)7 days; febrile neutropenia (absolute neutrophil count \[ANC\] less than (\<)1,000 per millimeter cube (/mm\^3) with single temperature \>38.3 degree Celsius (deg C), or sustained temperature of greater than or equal to (\>=) 38deg C for \>1 hour \[h\]); G\>=3 neutropenia with infection; G4 thrombocytopenia (unless the baseline count was \>=25,000/mm\^3 and \<50,000/mm\^3, in which case G4 thrombocytopenia was to be accompanied by \>=G2 bleeding), Platelet count \<10,000/mm\^3 was considered a DLT irrespective of other factors; G3 thrombocytopenia with \>=G2 bleeding; G4 AEs; G3 AE \>=5 days despite optimal supportive care (except AEs attributed to cytokine release syndrome \[CRS\]); G3 CRS (except CRS that have not been maximally treated or improved to \<=G1 within 48h); confirmed drug induced liver injury.
次要结局
- Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (SAEs), Treatment Emergent Treatment Related AEs and Treatment Emergent Treatment Related SAEs(From first dose of study intervention and up to 90 days after last dose or start of new anticancer therapy (maximum of 65.1 weeks of treatment))
- Number of Participants With Grade 3 or 4, Grade 5 TEAEs and Treatment Related TEAEs Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 5 Except for CRS and ICANS Graded According to ASTCT Grading Criteria 2019(From first dose of study intervention and up to 90 days after last dose or start of new anticancer therapy (maximum of 65.1 weeks of treatment))
- Number of Participants With Shift From Grade Less Than or Equal to (<=) 2 at Baseline to Grade 3 or 4 Post -Baseline in Hematology Parameters by NCI CTCAE v 5.0(From first dose of study intervention and up to 90 days after last dose or start of new anticancer therapy (maximum of 65.1 weeks of treatment))
- Number of Participants With Shift From Grade Less Than or Equal to (<=) 2 at Baseline to Grade 3 or 4 Post -Baseline in Chemistry Parameters by NCI CTCAE v 5.0(From first dose of study intervention and up to 90 days after last dose or start of new anticancer therapy (maximum of 65.1 weeks of treatment))
- Maximum Observed Serum Concentration (Cmax) of Elranatamab(Cycle 0: from Cycle 0 Day 1 (pre dose to the next dose of study intervention) [maximum of 9 days]; Cycle 1: from Cycle 1 Day 1 (pre dose to the next dose of study intervention) [maximum of 9 days])
- Time to Maximum Concentration (Tmax) of Elranatamab(Cycle 0: from Cycle 0 Day 1 (pre dose to the next dose of study intervention) [maximum of 9 days]; Cycle 1: from Cycle 1 Day 1 (pre dose to the next dose of study intervention) [maximum of 9 days])
- Area Under the Concentration-time Profile From Time Zero to the Time Tau (AUCtau) of Elranatamab(Cycle 0: from Cycle 0 Day 1 (pre dose to the next dose of study intervention) [maximum of 9 days]; Cycle 1: from Cycle 1 Day 1 (pre dose to the next dose of study intervention) [maximum of 9 days])
- Pre-dose Trough Serum Concentrations After Multiple Doses of Elranatamab(At pre-dose on Day 1 of Cycle 0, 3, 4, 5, 6, 7, 8, 12, 16; at pre-dose on Days 1, 8, 15 of Cycle 1 and 2)
- Number of Participants With Anti-drug Antibodies (ADA) of Elranatamab(From the date of first dose up to maximum of 65.1 weeks of treatment)
- Titers of ADA(Cycle1 Day1, Cycle1 Day15, Cycle2 Day1, Cycle3 Day1, Cycle4 Day1, Cycle6 Day1, Cycle8 Day1, Cycle12 Day1, Cycle16 Day1, End of treatment (maximum of 65.1 weeks of treatment))
- Number of Participants With Neutralizing Antibodies (NAb)(From the date of first dose up to maximum of 65.1 weeks of treatment)
- Objective Response Rate (ORR): Percentage of Participants With Objective Response(From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (maximum of 65.1 weeks of treatment))
- Time to Response (TTR)(From date of first dose to the first documentation of objective response that is subsequently confirmed (maximum of 65.1 weeks of treatment))
- Duration of Response (DOR)(From first documentation of objective response subsequently confirmed until confirmed PD or death due to any cause, or start of new anticancer therapy, whichever occurs first, or censoring date (maximum of 65.1 weeks of treatment))
- Progression Free Survival (PFS)(From date of first dose until confirmed PD or death due to any cause, or start of new anticancer therapy, whichever occurs first, or censoring date (maximum of 65.1 weeks of treatment))
- Overall Survival (OS)(From the date of first dose until death due to any cause or censoring date (maximum of 65.1 weeks of treatment))
- Minimal Residual Disease (MRD) Negativity Rate(From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (maximum of 65.1 weeks of treatment))
研究者
研究点 (2)
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