A Phase 1/2a, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-BX102 Monotherapy and Combination With Pembrolizumab in Adult Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 10
- 主要终点
- Dose Escalation and Dose Expansion phase: Number of participants with adverse events
研究概览
简要总结
This study is to evaluate the safety and tolerability of JAB-BX102 monotherapy and combination therapy with pembrolizumab in adult participants with advanced solid tumors.
详细描述
The primary objective of this study is to evaluate the safety and tolerability of JAB-BX102 monotherapy to determine the MTD(maximum tolerated dose) and RP2D(Recommended Phase 2 Dose) during Dose Escalation phase; then to evaluate preliminary antitumor activity when JAB-BX102 is administered in combination with pembrolizumab during Dose Expansion phase in patients with advanced solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be able to provide an archived tumor sample
- •Must have histologically or cytologically confirmed metastatic or locally advanced solid tumor
- •Must be refractory to or become intolerant of existing therapy(ies) known to provide clinical benefit for their condition, or patient has no access to SOC treatment.
- •Must have at least 1 measurable lesion per RECIST v1.1
- •Must have adequate organ functions
排除标准
- •Has central nervous system(CNS) metastases or carcinomatous meningitis, except if CNS metastases treated and no evidence of radiographic progression or hemorrhage for at least 28 days
- •Active infection requiring systemic treatment within 7 days
- •Active hepatitis C virus(HBV), hepatitis C virus(HCV), or HIV
- •Any severe and/or uncontrolled medical conditions
- •Left ventricular ejection fraction(LVEF) ≤50% assessed by echocardiogram (ECHO) or multigated acquisition scan (MUGA)
- •QTcF(Corrected QT interval - Fredericia formula) interval >470 msec
- •Experiencing unresolved CTCAE 5.0 Grade >1 toxicities
研究组 & 干预措施
Arm A, JAB-BX102 monotherapy, Phase 1, Dose Escalation
Dose escalation of JAB-BX102 will be administered as monotherapy to determine the MTD and RP2D.
干预措施: JAB-BX102 (anti-CD73 monoclonal antibody) (Biological)
Arm B, JAB-BX102 combination with pembrolizumab, Phase 2a, Dose Expansion
JAB-BX102 will be administered in combination with pembrolizumab in specific solid tumor patients to evaluate the preliminary antitumor activity.
干预措施: JAB-BX102 (anti-CD73 monoclonal antibody) (Biological)
Arm B, JAB-BX102 combination with pembrolizumab, Phase 2a, Dose Expansion
JAB-BX102 will be administered in combination with pembrolizumab in specific solid tumor patients to evaluate the preliminary antitumor activity.
干预措施: pembrolizumab (anti-PD-1 monoclonal antibody) (Biological)
结局指标
主要结局
Dose Escalation and Dose Expansion phase: Number of participants with adverse events
时间窗: Up to 3 years
Patients will be assessed for incidence and severity of adverse events (AEs) according to NCI-CTCAE 5.0.
Expansion phase: Duration of response (DOR)
时间窗: Up to 3 years
DOR is defined as the time from the participant's initial objective response (CR or PR) to disease progression per CTCAE v1.1 or death due to any cause, whichever occurs first.
Dose Escalation phase Number of participants with dose limiting toxicities (DLTs)
时间窗: First 21 days of Cycle 1
A DLT is defined as the clinically significant TRAE(treatment-related adverse events) or abnormal laboratory values assessment during the first 21 days of Cycle 1 and excludes events that are deemed clearly related to underlying disease, progression, or intercurrent illness.
Dose Expansion phase: Overall response rate (ORR)
时间窗: Up to 3 years - from baseline to RECIST confirmed Progressive Disease
ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) per RECIST v 1.1.
次要结局
- To characterize the pharmacokinetics(PK) profile of JAB-BX102 as a single agent and in combination with pembrolizumab(Up to 3 years)
- Dose Escalation phase: Overall response rate (ORR)(Up to 3 years - from baseline to RECIST confirmed Progressive Disease)
- Dose Escalation phase: Duration of response (DOR)(Up to 3 years)
- Dose Escalation and Dose Expansion phase: Disease Control Rate (DCR)(Up to 3 years)
- Dose Escalation and Dose Expansion phase: Progression-free survival (PFS)(Up to 3 years)