JPRN-jRCT2031230426招募中1 期
A Phase 1, Open-Label, Multicenter Study of INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms
eda Eiji0 个研究点目标入组 225 人开始时间: 2023年10月31日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 225
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. Eastern Cooperative Oncology Group (ECOG) performance status score of the following:
- •- 0 or 1 for the dose-escalation part (Part 1a).
- •- 0, 1, or 2 for the dose-expansion parts (Parts 1b and 1c).
- •2. Life expectancy > 6 months
- •3. Willingness to undergo a pretreatment and regular on-study BM biopsies and aspirates (as appropriate to disease)
- •4. Existing documentation from a qualified local laboratory of CALR exon-9 mutation not older than 12 months prior to Cycle 1 Day 1
- •MF participants
- •5. Histologically confirmed diagnosis of primary myelofibrosis (PMF) or post-ET MF according to the 2022 WHO criteria
- •6. Bone marrow and peripheral blood myeloblast count < 5%
- •7. Evidence of evaluable residual burden of disease:
- •- Spleen> 10 cm below the left subcostal margin
- •- Spleen 5 to 10 cm below left subcostal margin AND presence of 1 symptom score >= 5 or 2 symptom scores >= 3 using MPN SAF TSS
- •ET participants:
- •8. Confirmed diagnosis of ET according to the 2022 WHO criteria
- •9. Revised IPSET-thrombosis high-risk
- •10. Documented resistance/intolerance to at least 1 line of prior cytoreductive therapy (including but not limited to hydroxyurea, interferon, thalidomide, busulfan, lenalidomide, or anagrelide)
- •11. Platelet counts > 600 x 109/L
- •12. As applicable:
- •- previously treated with JAK inhibitors for >= 12 weeks and are resistant, or refractory, or intolerant to, or lost response to, or ineligible for JAK inhibitor treatment
- •TGB-MF SubOpt R:
- •- Intermediate- or high-risk DIPSS MF
- •- Must have been on a therapeutic regimen of ruxolitinib (ie, between 5 and 25 mg BID) for at least 12 weeks and at least 8 consecutive weeks on a stable dose (1 dose reduction due to toxicities allowed) immediately preceding the first dose of study treatment
- •- Unlikely to benefit from further ruxolitinib monotherapy in the opinion of the investigator, and meet the criteria for evidence of evaluable residual burden of disease
- •TGA-MF TxN and TGB-MF TxN:
- •- Intermediate-2 or high-risk DIPSS MF
- •- Must be JAK inhibitor treatment naive (TxN) and have an indication for initiation of ruxolitinib treatment
- •13. Other protocol-defined Inclusion Criteria may apply.
排除标准
- •1. Presence of any hematological malignancy other than ET, PMF, or post-ET MF
- •2. Active invasive malignancy over the previous 2 years
- •3. Active HBV/HCV, HIV
- •4. History of clinically significant or uncontrolled cardiac disease
- •5. Has undergone any prior allogenic or autologous stem-cell transplantation or such transplantation is planned
- •6. Laboratory values outside the Protocol-defined ranges
- •7. Participants undergoing treatment with G-CSF or GM-CSF, romiplostim, or eltrombopag at any time within 4 weeks before the first dose of study
- •8. For participants with ET only: active bleeding within 28 days prior to study enrollment
- •9. For TGBs only: Undergoing treatment with a potent/strong inhibitor or inducer of CYP 3A4/5 within 14 days or 5 half-lives (whichever is longer) before the first dose of study treatment, or expected to receive such treatment during the study
- •10. Other protocol-defined Exclusion Criteria may apply.
研究者
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