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临床试验/NCT04720976
NCT04720976已完成1 期

A Phase 1/2a, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-3312 Based Combination Therapies in Adult Patients With Advanced Solid Tumors

Allist Pharmaceuticals, Inc.1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2021年3月23日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
58
试验地点
1
主要终点
Number of participants with adverse events

研究概览

简要总结

To evaluate the safety and tolerability of JAB-3312 administered in investigational regimens in adult participants with advanced solid tumors.

详细描述

To assess the safety and tolerability and determine the Recommended phase 2 dose (RP2D) of JAB-3312 in combination with PD1 inhibitor or MEK inhibitor 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

入选标准

  • Must have histologically or cytologically confirmed metastatic or locally advanced solid tumor. Some cohorts must meet specific expression or gene mutation where indicated
  • Sufficient organ function
  • Participants must have at least 1 measurable lesion as defined by RECIST v1.1
  • Must be able to provide an archived tumor sample
  • ECOG performance status score of 0 or 1.

排除标准

  • History of cancer that is histologically distinct from the cancers under study
  • Active or untreated central nervous system (CNS) metastases
  • History of pneumonitis or interstitial lung disease (ILD)
  • Has active hepatitis B, hepatitis C infection, HIV
  • Any severe and/or uncontrolled medical conditions
  • LVEF ≤50%
  • QTcF >470 msec

研究组 & 干预措施

JAB-3312+Pembrolizumab dose escalation

Experimental

Dose escalation

干预措施: JAB-3312 (Drug)

JAB-3312+Pembrolizumab dose escalation

Experimental

Dose escalation

干预措施: Pembrolizumab (Drug)

JAB-3312+ Binimetinib dose escalation

Experimental

Dose escalation

干预措施: JAB-3312 (Drug)

JAB-3312+ Binimetinib dose escalation

Experimental

Dose escalation

干预措施: Binimetinib (Drug)

JAB-3312+Pembrolizumab dose expansion

Experimental

Dose expansion

干预措施: JAB-3312 (Drug)

JAB-3312+Pembrolizumab dose expansion

Experimental

Dose expansion

干预措施: Pembrolizumab (Drug)

JAB-3312+Binimetinib dose expansion

Experimental

Dose expansion

干预措施: JAB-3312 (Drug)

JAB-3312+Binimetinib dose expansion

Experimental

Dose expansion

干预措施: Binimetinib (Drug)

JAB-3312+Sotorasib dose escalation

Experimental

Dose escalation

干预措施: JAB-3312 (Drug)

JAB-3312+Sotorasib dose escalation

Experimental

Dose escalation

干预措施: Sotorasib (Drug)

JAB-3312+ Osimertinib dose escalation

Experimental

Dose escalation

干预措施: JAB-3312 (Drug)

JAB-3312+ Osimertinib dose escalation

Experimental

Dose escalation

干预措施: Osimertinib (Drug)

JAB-3312+ Sotorasib dose expansion

Experimental

Dose expansion

干预措施: JAB-3312 (Drug)

JAB-3312+ Sotorasib dose expansion

Experimental

Dose expansion

干预措施: Sotorasib (Drug)

JAB-3312+ Osimertinib dose expansion

Experimental

Dose expansion

干预措施: JAB-3312 (Drug)

JAB-3312+ Osimertinib dose expansion

Experimental

Dose expansion

干预措施: Osimertinib (Drug)

结局指标

主要结局

Number of participants with adverse events

时间窗: 24 months

All patients participating in this study will be assessed for incidence and severity of adverse events (AEs) and serious AEs, including changes in laboratory values, vital signs, electrocardiograms, cardiac imaging and ophthalmological assessments (Dose escalation phase)

Objective response rate (ORR)

时间窗: 24 months

ORR is defined as the proportion of participants with complete response or partial response (CR+PR). (Dose expansion phase)

Duration of response (DOR)

时间窗: 24 months

DOR is defined as the time from the participant's initial objective response (CR or PR) to study drug therapy, to disease progression or death due to any cause, whichever occurs first. (Dose expansion phase)

Progression-free survival (PFS)

时间窗: 24 months

PFS is defined as the interval of time between the date of first treatment to the earliest date of disease progression or death which occurs first. (Dose expansion phase)

Overall survival (OS)

时间窗: 24 months

OS is defined as the interval of time between the date of first treatment until death, loss to follow up or termination of the study by the sponsor. (Dose expansion phase)

Number of participants with dose limiting toxicities

时间窗: 24 months

Incidence of dose limiting toxicities (DLTs) in the dose escalation phase. A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first treatment cycle. (Dose escalation phase)

Duration of response (DCR)

时间窗: 24 months

DCR is defined as proportion of participants with complete response, partial response, stable disease(CR+PR+SD). (Dose expansion phase)

次要结局

  • Duration of response (DOR)(24 months)
  • Number of participants with adverse events(24 months)
  • Objective response rate (ORR)(24 months)
  • Duration of response (DCR)(24 months)
  • Progression-free survival (PFS)(24 months)
  • Overall survival (OS)(24 months)
  • Area under the plasma concentration-time curve (AUC)(24 months)
  • Plasma concentration (Cmax)(24 months)
  • Time to achieve Cmax (Tmax)(24 months)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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