jRCT2031240718招募中不适用
A Phase 1/2 Open-Label, Multicenter, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of BH-30643 in Adult Subjects With Locally Advanced or Metastatic NSCLC Harboring EGFR and/or HER2 Mutations(SOLARA)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 18
- 主要终点
- Dose-limiting toxicities(DLTs) (Phase 1, Dose Escalation)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •=>18 years or legal adult.
- •Pathologically confirmed diagnosis of locally advanced or metastatic NSCLC with EGFR(classical, atypical, exon20 insertion)or HER2 mutations in the kinase domain of exons 18, 19, 20, or
- •EGFR mutations include activating and acquired EGFR resistance mutations that might form compound mutations.
- •Had received standard therapies.
- •Has at least 1 measurable target extracranial lesion according to RECIST v1.
- •Eastern Cooperative Oncology Group Performance Status =<
- •Has a life expectancy of >=3 months.
- •Has adequate hematologic, hepatic, and renal function.
- •The above are a summary; other Inclusion Criteria details may apply.
排除标准
- •History of any concurrent malignancy within the previous 2 years.
- •Known other oncogenic driver alterations (eg, moderate or high MET amplification) or histological transformation (eg, to small cell carcinoma, etc.).
- •Unresolved toxicities from prior therapies.
- •Any significant and uncontrolled medical condition, such as infection.
- •History of interstitial lung disease from any cause
- •Clinically significant cardiovascular event within 6 months or significant history of major organ.
- •Actively receiving investigational therapy(ies) in another clinical study.
- •The above are a summary; other Exclusion Criteria details may apply.
结局指标
主要结局
Dose-limiting toxicities(DLTs) (Phase 1, Dose Escalation)
时间窗: Within the first 21 days of the first dose of BH-30643.
Assess dose-limiting toxicities (DLTs) as defined in the study protocol.
Recommended Phase 2 dose (RP2D) (Phase 1, Dose Expansion/Optimization)
时间窗: Within 21 days of last participant dosed during Dose Expansion/Optimization.
Determine the RP2D for Phase 2.
Objective Response Rate (ORR) (Phase 2)
时间窗: Approximately 3 years after the first participant dosed.
Determine ORR as assessed by Blinded Independent Central Review (BICR).
次要结局
- Safety(From enrollment through study completion, approximately 48 months.)
- Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration(AUClast) of BH-30643 for Single dose(Phase 1)(Predose and up to 24 hours postdose.)
- Maximum observed plasma concentration Cmax) of BH-30643 for Single dose(Phase 1)(Predose and up to 24 hours postdose.)
- Time to reach Cmax(Tmax)of BH-30643 for Single dose(Phase 1)(Predose and up to 24 hours postdose.)
- Area under the plasma concentration-time curve at steady state (AUCss)of BH-30643 for multiple doses(Phase 1) at steady state(Predose and up to 24 hours postdose.)
- Objective Response Rate(ORR)(From enrollment until the date of the first documented progression or death from any cause, whichever occurs first, assessed up to study ends or patient discontinue from the study, whichever occurs first (up to approximately 4 years).)
- Disease Control Rate (DCR)(From enrollment until the date of the first documented progression or death from any cause, whichever occurs first, assessed up to study ends or patient discontinue from the study, whichever occurs first(up to approximately 4 years).)
- Clinical benefit Rate(CBR)(From enrollment until the date of the first documented progression or death from any cause, whichever occurs first, assessed up to study ends or patient discontinue from the study, whichever occurs first(up to approximately 4 years).)
- Time to Tumor Response(TTR)(From first dose to the first occurrence of response, assessed up to the date of first documented progression or death from any cause, whichever occurs first (up to approximately 4 years).)
- Duration of Response(DOR)(From first occurrence of response until the date of the first documented progression or death from any cause, whichever occurs first, assessed up to study ends or patient discontinue from the study, whichever occurs first (up to approximately 4 years).)
- Progression-free Survival(PFS)(From enrollment until the date of the first documented progression or death from any cause, whichever occurs first, assessed up to study ends or patient discontinue from the study, whichever occurs first (up to approximately 4 years).)
- Overall Survival(From enrollment until the date of death from any cause, assessed up to study ends or patient discontinue from the study, whichever occurs first(up to approximately 4 years).)
- EORTC-QLQ-C30(From enrollment until the end of treatment, up till patient discontinue from treatment due to any reason(up to approximately 4 years).)
- NSCLC-SAQ(From enrollment until the end of treatment, up till patient discontinue from treatment due to any reason(up to approximately 4 years).)
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