Phase Ia/Ib Study of FXB0871 Monotherapy in Locally Advanced/Metastatic Solid Tumors
A Phase 1a/1b Open-Label, Multicenter, Dose Escalation, and Dose Expansion Trial to Evaluate the Safety, Anti-tumor Activity, Pharmacokinetic/Pharmacodynamic Characteristics of FXB0871 as Monotherapy in Participants With Selected Locally Advanced or Metastatic Solid Tumors
This is a phase 1a/1b, open-label, multicenter, dose-escalation and dose-expansion study evaluating the safety, tolerability, antitumor activity, pharmacokinetics, and pharmacodynamics of FXB0871 monotherapy in adults with selected locally advanced or metastatic solid tumors.
In Part Ia, participants with selected solid tumors that have progressed after, are intolerant to, or are not suitable for standard therapy will receive FXB0871 in dose-escalation cohorts to determine the maximum tolerated dose and/or recommended phase 2 dose.
In Part Ib, participants with PD-(L)1-resistant non-small cell lung cancer or hepatocellular carcinoma will receive FXB0871 in dose-expansion cohorts to further evaluate antitumor activity, safety, and dose optimization.
研究概览
地位
尚未招聘
详细说明
This first-in-human study consists of a dose-escalation part (Part Ia) and a dose-expansion part (Part Ib). In Part Ia, adults with selected locally advanced or metastatic solid tumors will receive FXB0871 monotherapy by intravenous infusion every 2 weeks in sequential pre-determinde dose cohorts using a Bayesian optimal interval design. The planned dosing schedule is every 2 weeks, with a dose-limiting toxicity observation period of the first 2 treatment cycles. Additional intermediate dose levels, cohort expansion, and schedule optimization to every 3 or 4 weeks may be allowed according to protocol-defined safety, PK/PD, and preliminary antitumor activity data.
Part Ib will start after determination of the monotherapy recommended phase 2 dose (RP2D). Cohort A will enroll participants with PD-(L)1-resistant locally advanced or metastatic non-small cell lung cancer and randomize them 1:1 to receive FXB0871 at the RP2D or at a lower dose selected on the basis of Part Ia data. Cohort B will enroll participants with PD-(L)1-resistant locally advanced or metastatic hepatocellular carcinoma to receive FXB0871 at the RP2D. Participants may continue study treatment for up to 12 months or until unacceptable toxicity, disease progression, or another protocol-defined discontinuation criterion is met.
研究类型
介入性
注册 (估计的)
138
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Caicun Zhou
- 电话号码：+86 13301825532
- 邮箱：caicunzhoudr@163.com
研究联系人备份
- 姓名：Fei Zhou
- 电话号码：+86 13801751704
- 邮箱：story185@126.com
学习地点
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Shanghai Municipality
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Shanghai、Shanghai Municipality、中国、200000
- Shanghai East Hospital
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接触：
- Caicun Zhou
- 电话号码：+86 13301825532
- 邮箱：caicunzhoudr@163.com
-
接触：
- Fei Zhou
- 电话号码：+86 13801751704
- 邮箱：story185@126.com
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Signed informed consent.
- Age ≥18 years.
- Histologically confirmed selected locally advanced or metastatic solid tumor with progression on, intolerance to, or no suitable standard therapy.
- ECOG performance status 0 or 1.
- At least one measurable lesion per RECIST v1.1.
- Pretreatment tumor tissue available (archival or fresh biopsy).
- Life expectancy ≥12 weeks.
- Oxygen saturation ≥92% on room air.
- Left ventricular ejection fraction >50%.
- Adequate hematologic, coagulation, renal, hepatic, and cardiac function.
- Women of childbearing potential and sexually active men must use highly effective contraception.
- Tumor-specific eligibility applies, including prior anti-PD-(L)1 treatment failure for the selected cohorts.
Key Exclusion Criteria:
- Systemic anti-cancer therapy, major surgery, or radical radiotherapy within 4 weeks before first dose.
- Prior treatment with IL-2, IL-15, or IL-7.
- Active autoimmune disease requiring systemic treatment or immunodeficiency.
- Systemic corticosteroids (≥10 mg/day prednisone equivalent) or other immunosuppressive therapy within 28 days before first dose, with limited protocol-defined exceptions.
- Active or untreated central nervous system metastases, carcinomatous meningitis, or leptomeningeal disease.
- Uncontrolled infection or clinically significant unresolved toxicities from prior therapy.
- Clinically significant cardiovascular/cerebrovascular disease, uncontrolled effusions/ascites, uncontrolled hypertension, or QTcF >470 ms.
- Active hepatitis B/C, syphilis, or HIV infection.
- Clinically significant interstitial lung disease or active noninfectious pneumonitis.
- Pregnancy or breastfeeding.
- Any other serious medical or psychiatric condition that, in the investigator's judgment, would make participation inappropriate.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Arm1：Part Ia Dose Escalation
Participants with selected locally advanced or metastatic solid tumors will receive FXB0871 monotherapy by intravenous infusion every 2 weeks in sequential pre-determined dose-escalation cohorts or at intermediate dose levels every 2 weeks
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FXB0871 is administered by intravenous infusion at pre-determined dose level in Part Ia every 2 weeks.
Treatment may continue for up to 12 months or until unacceptable toxicity, disease progression, or another protocol-defined discontinuation criterion is met.
其他名称：
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实验性的：Arm2：Part Ib Dose Expansion (NSCLC, RP2D)
Participants with locally advanced or metastatic IO-resistant NSCLC will be randomized 1:1 to receive FXB0871 monotherapy at RP2D from Phase Ia by intravenous infusion every 2 weeks
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FXB0871 is administered by intravenous infusion at pre-determined dose level in Phase Ib every 2 weeks.
Treatment may continue for up to 12 months or until unacceptable toxicity, disease progression, or another protocol-defined discontinuation criterion is met.
其他名称：
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实验性的：Arm3：Part Ib Dose Expansion(NSCLC, <RP2D)
Participants with locally advanced or metastatic IO-resistant NSCLC will be randomized 1:1 to receive FXB0871 monotherapy at a selected lower dose than RP2D from Phase Ia by intravenous infusion every 2 weeks
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FXB0871 is administered by intravenous infusion at pre-determined dose level in Phase Ib every 2 weeks.
Treatment may continue for up to 12 months or until unacceptable toxicity, disease progression, or another protocol-defined discontinuation criterion is met.
其他名称：
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实验性的：Arm4：Part Ib Dose Expansion(HCC, RP2D)
Participants with locally advanced or metastatic IO-resistant HCC will receive FXB0871 monotherapy at RP2D from Phase Ia by intravenous infusion every 2 weeks
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FXB0871 is administered by intravenous infusion at pre-determined dose level in Phase Ib every 2 weeks.
Treatment may continue for up to 12 months or until unacceptable toxicity, disease progression, or another protocol-defined discontinuation criterion is met.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence and severity of dose-limiting toxicities (DLTs) in Phase Ia
大体时间：First 2 cycles after first dose (each cycle = 14 days; approximately 28 days).
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Percentage of participants with protocol-defined DLTs during the DLT observation period in the dose-escalation phase
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First 2 cycles after first dose (each cycle = 14 days; approximately 28 days).
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Incidence and severity of adverse events (AEs), serious adverse events (SAEs), AEs leading to dose delay/interruption/reduction/treatment discontinuation in Phase Ia
大体时间：From first dose through 90 days after last dose or initiation of new anti-tumor therapy, whichever occurs first
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Safety assessed by the incidence of treatment-emergent adverse events, serious adverse events, AEs leading to dose delay/interruption/reduction/treatment discontinuation in Phase Ia.
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From first dose through 90 days after last dose or initiation of new anti-tumor therapy, whichever occurs first
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Objective response rate (ORR) in Phase Ib
大体时间：From first dose until disease progression, start of new anti-tumor therapy, withdrawal, death, or end of study (assessed every 8±1 weeks; approximately up to 24 months).
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ORR defined as the proportion of participants with a best overall response of complete response (CR) or partial response (PR) per RECIST v1.1 in Phase Ib.
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From first dose until disease progression, start of new anti-tumor therapy, withdrawal, death, or end of study (assessed every 8±1 weeks; approximately up to 24 months).
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Objective response rate (ORR) in Phase Ia
大体时间：From first dose until disease progression, start of new anti-tumor therapy, withdrawal, death, or end of study, whichever occurs first (tumor assessments every 8 ± 1 weeks; approximately up to 24 months).
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Objective response rate (ORR), defined as the proportion of participants with a best overall response of complete response (CR) or partial response (PR), as assessed per RECIST v1.1 in Phase Ia.
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From first dose until disease progression, start of new anti-tumor therapy, withdrawal, death, or end of study, whichever occurs first (tumor assessments every 8 ± 1 weeks; approximately up to 24 months).
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Disease control rate (DCR) in Phase Ia
大体时间：From first dose until disease progression, start of new anti-tumor therapy, withdrawal, death, or end of study, whichever occurs first (tumor assessments every 8 ± 1 weeks; approximately up to 24 months).
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Disease control rate (DCR), defined as the proportion of participants with a best overall response of CR, PR, or stable disease (SD), as assessed per RECIST v1.1 in Phase Ia.
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From first dose until disease progression, start of new anti-tumor therapy, withdrawal, death, or end of study, whichever occurs first (tumor assessments every 8 ± 1 weeks; approximately up to 24 months).
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Duration of response (DOR) in Phase Ia
大体时间：From first documented CR or PR until first documented disease progression or death from any cause, whichever occurs first (approximately up to 24 months).
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Duration of response (DOR), defined for participants with confirmed CR or PR as the time from first documented response to first documented disease progression or death from any cause, whichever occurs first, as assessed per RECIST v1.1 in Phase Ia.
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From first documented CR or PR until first documented disease progression or death from any cause, whichever occurs first (approximately up to 24 months).
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Progression-free survival (PFS) in Phase Ia
大体时间：From first dose until first documented disease progression or death from any cause, whichever occurs first (approximately up to 24 months).
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Progression-free survival (PFS), defined as the time from first dose to first documented disease progression or death from any cause, whichever occurs first, as assessed per RECIST v1.1 in Phase Ia.
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From first dose until first documented disease progression or death from any cause, whichever occurs first (approximately up to 24 months).
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Peak serum concentration (Cmax)
大体时间：Predose up to Day 8
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Maximum observed concentration
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Predose up to Day 8
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Time to maximum observed concentration (Tmax)
大体时间：Predose up to Day 8
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Time to maximum observed drug concentration
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Predose up to Day 8
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Area under the serum concentration-time curve (AUC0-last)
大体时间：Predose up to Day 8
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Area under the serum concentration-time curve from time 0 to last measurable drug concentration
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Predose up to Day 8
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Area under the serum concentration-time curve (AUC0-∞)
大体时间：Predose up to Day 8
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Area under the concentration-time curve from time zero (pre-dose) extrapolation to infinite time
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Predose up to Day 8
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Area under the serum concentration-time curve (AUCtau)
大体时间：Predose up to Day 8
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Area under the concentration-time curve over the dosing interval
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Predose up to Day 8
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Trough concentration (Ctrough)
大体时间：up to Day 8
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Observed concentration at the end of a dosing interval, immediately before next administration
|
up to Day 8
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Clearance (CL)
大体时间：Predose up to Day 8
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Systemic (total body) clearance following iv administration
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Predose up to Day 8
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Volume of distribution (Vz)
大体时间：Predose up to Day 8
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Volume of distribution following iv administration
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Predose up to Day 8
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Half-life (t1/2)
大体时间：Predose up to Day 8
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Terminal phase half-life
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Predose up to Day 8
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Average concentration (Cavg)
大体时间：Predose up to Day 8
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Average concentration over a dosing interval
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Predose up to Day 8
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Accumulation ratio (Rac)
大体时间：Predose up to Day 8
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Accumulation ratio
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Predose up to Day 8
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Incidence and severity of AEs/SAEs and AEs leading to dose modification or discontinuation in Phase Ib
大体时间：From first dose through 90 days after last dose or initiation of new anti-tumor therapy, whichever occurs first.
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Safety and tolerability in the dose-expansion phase.
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From first dose through 90 days after last dose or initiation of new anti-tumor therapy, whichever occurs first.
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ORR by modified RECIST (mRECIST) in the HCC cohort of Phase Ib
大体时间：From first dose until disease progression, start of new anti-tumor therapy, withdrawal, death, or end of study (assessed every 8±1 weeks; approximately up to 24 months).
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ORR in participants with hepatocellular carcinoma assessed by mRECIST.
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From first dose until disease progression, start of new anti-tumor therapy, withdrawal, death, or end of study (assessed every 8±1 weeks; approximately up to 24 months).
|
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Disease control rate (DCR) in Phase Ib
大体时间：From first dose until disease progression, start of new anti-tumor therapy, withdrawal, death, or end of study, whichever occurs first (tumor assessments every 8 ± 1 weeks; approximately up to 24 months).
|
Disease control rate (DCR), defined as the proportion of participants with a best overall response of CR, PR, or SD, as assessed per RECIST v1.1 in Phase Ib.
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From first dose until disease progression, start of new anti-tumor therapy, withdrawal, death, or end of study, whichever occurs first (tumor assessments every 8 ± 1 weeks; approximately up to 24 months).
|
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Time to response (TTR) in Phase Ib
大体时间：From first dose to first documented CR or PR (tumor assessments every 8 ± 1 weeks; approximately up to 24 months).
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Time to response (TTR), defined as the time from first dose to the first documented CR or PR, as assessed per RECIST v1.1 in Phase Ib.
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From first dose to first documented CR or PR (tumor assessments every 8 ± 1 weeks; approximately up to 24 months).
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Duration of response (DOR) in Phase Ib
大体时间：From first documented CR or PR until first documented disease progression or death from any cause, whichever occurs first (approximately up to 24 months).
|
Duration of response (DOR), defined for participants with confirmed CR or PR as the time from first documented response to first documented disease progression or death from any cause, whichever occurs first, as assessed per RECIST v1.1 in Phase Ib.
|
From first documented CR or PR until first documented disease progression or death from any cause, whichever occurs first (approximately up to 24 months).
|
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Title:Progression-free survival (PFS) in Phase Ib
大体时间：From first dose until first documented disease progression or death from any cause, whichever occurs first (approximately up to 24 months).
|
Progression-free survival (PFS), defined as the time from first dose to first documented disease progression or death from any cause, whichever occurs first, as assessed per RECIST v1.1 in Phase Ib.
|
From first dose until first documented disease progression or death from any cause, whichever occurs first (approximately up to 24 months).
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Overall survival (OS) in Phase Ib
大体时间：From first dose until death from any cause (approximately up to 24 months).
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Overall survival measured from first dose to death from any cause.
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From first dose until death from any cause (approximately up to 24 months).
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年5月15日
初级完成 (估计的)
2030年4月23日
研究完成 (估计的)
2030年11月18日
研究注册日期
首次提交
2026年4月7日
首先提交符合 QC 标准的
2026年4月23日
首次发布 (实际的)
2026年4月30日
研究记录更新
最后更新发布 (实际的)
2026年4月30日
上次提交的符合 QC 标准的更新
2026年4月23日
最后验证
2026年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.