NCT06290388终止1 期
A Phase 1/2a, Multicenter, Open-label, Dose Escalation and Expansion Study of Intravenously Administered 23ME-01473 in Participants With Advanced Solid Malignancies
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 3
- 主要终点
- Phase 1: Incidence and severity of adverse events (AEs)
研究概览
简要总结
This is a first-in-human open-label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of 23ME-01473 given by intravenous infusion in participants with advanced solid cancers who have progressed or are intolerant of available standard therapies.
详细描述
This study includes a dose escalation portion to determine the maximum tolerated dose (MTD) and/or the recommended phase 2 dose (RP2D) to evaluate the clinical activity of 23ME-01473 and further evaluate its safety, tolerability, pharmacokinetics, and pharmacodynamics in participants with solid malignancies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Phase 1: Adults ≥ 18 years of age
- •Phase 1: Histologically-diagnosed locally advanced (unresectable), or metastatic carcinoma or sarcoma that has progressed after standard therapy for the specific tumor type.
- •Adults 18+: Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •Life expectancy ≥ 12 weeks
- •Phase 1: Participants with evaluable disease are eligible regardless of tumor type, RECIST 1.1 can be used to assess disease progression.
排除标准
- •Females who are pregnant (positive serum pregnancy test within 7 days prior to study drug administration) or breastfeeding.
- •Immune-Related Medical History
- •Active autoimmune disease that has required systemic disease-modifying or immunosuppressive treatment within the last 2 years
- •Receipt of systemic immunosuppressive therapy (e.g. steroids) within 4 weeks prior to the start of study drug administration
- •History of idiopathic pulmonary fibrosis, interstitial lung disease, organizing pneumonia, non-infectious pneumonia that required steroids, or evidence of active, non-infectious pneumonitis
- •History of Grade ≥ 3 immune-mediated toxicity
- •Prior allogeneic or autologous bone marrow transplant, or other solid organ transplant
- •History of a positive test for:
- •Hepatitis C virus (HCV) infection, except for those who have completed curative therapy for HCV and have undetectable HCV RNA
- •Hepatitis B virus (HBV) infection, except for those who are receiving treatment with HBV-active nucleos(t)ide antiviral therapy at the time of study entry and have undetectable HBV DNA
- •Human Immunodeficiency Virus (HIV) infection, except those who meet the following criteria: CD4+ T cells ≥ 350 cells/μL, no history of Acquired Immunodeficiency Syndrome (AIDS)-defining opportunistic infections, HIV RNA < 50 copies/mL, and on a stable antiretroviral regimen for at least 3 months
- •Prior anticancer therapy, including chemotherapy, targeted therapy, biological therapy or immune-checkpoint inhibitors within 4 weeks or 5 drug half-lives (whichever is shorter)
- •History of another malignancy in the previous 2 years, unless cured by surgery alone and continuously disease free.
- •Uncontrolled or symptomatic CNS (central nervous system) metastases and/or carcinomatous meningitis
- •Recent history (within 6 months) of serious cardiovascular disease
研究组 & 干预措施
Phase 1
Experimental
Participants will receive escalating doses of 23ME-01473
干预措施: 23ME-01473 (Drug)
结局指标
主要结局
Phase 1: Incidence and severity of adverse events (AEs)
时间窗: From Screening through 90 days post treatment
Phase 1:Incidence and severity of dose-limiting toxicities (DLTs)
时间窗: First dose through 21 days post dose
Phase 1 Incidence and severity of serious adverse events (SAEs)
时间窗: From Screening through 90 days post treatment
ORR based on investigator assessment against RECIST 1.1 criteria
时间窗: From baseline until disease progression (up to 5 years)
次要结局
- Terminal half-life (T1/2) following multiple doses of 23ME-01473([Time Frame: Cycle 4 (21 days, from Cycle 4 Day 1 predose to Cycle 5 Day 1 predose)])
- Phase 1: Prevalence and incidence of antidrug antibodies (ADA) to 23ME-01473(From first dose up to 5 days post treatment discontinuation)
- Time of maximum serum concentration (Tmax) following a single dose of 23ME-01473([Time Frame: Cycle 1 (21 days, from Cycle 1 Day 1 predose to Cycle 2 Day 1 predose)])
- Area under the concentration-time curve from time zero to the end of the dosing interval (AUCtau) following multiple doses of 23ME-01473([Time Frame: Cycle 4 (21 days, from Cycle 4 Day 1 predose to Cycle 5 Day 1 predose)])
- Serum concentration at the end of the dosing interval (Ctau) following multiple doses of 23ME-01473([Time Frame: Cycle 4 (21 days, from Cycle 4 Day 1 predose to Cycle 5 Day 1 predose)])
- Progression free survival (PFS)(From baseline until disease progression (up to 5 years))
- Duration of response (DoR)(From baseline until disease progression (up to 5 years))
- Disease Control Rate (DCR)(From baseline until disease progression (up to 5 years))
- Last measurable serum concentration (Clast) following a single dose of 23ME-01473([Time Frame: Cycle 1 (21 days, from Cycle 1 Day 1 predose to Cycle 2 Day 1 predose)])
- Maximum serum concentration (Cmax) following multiple doses of 23ME-01473([Time Frame: Cycle 4 (21 days, from Cycle 4 Day 1 predose to Cycle 5 Day 1 predose)])
- Area under the concentration-time curve from zero to the last measurable concentration (AUClast) following a single dose of 23ME-01473([Time Frame: Cycle 1 (21 days, from Cycle 1 Day 1 predose to Cycle 2 Day 1 predose)])
- Area under the concentration-time curve from zero extrapolated to infinity (AUCinf) following a single dose of 23ME-01473([Time Frame: Cycle 1 (21 days, from Cycle 1 Day 1 predose to Cycle 2 Day 1 predose)])
- Time of maximum serum concentration (Tmax) following multiple doses of 23ME-01473([Time Frame: Cycle 4 (21 days, from Cycle 4 Day 1 predose to Cycle 5 Day 1 predose)])
- Phase 1: Objective response rate (ORR)(From baseline until disease progression (up to 5 years))
- Terminal half-life (T1/2) following a single dose of 23ME-01473([Time Frame: Cycle 1 (21 days, from Cycle 1 Day 1 predose to Cycle 2 Day 1 predose])
研究者
研究点 (3)
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