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临床试验/NCT04092673
NCT04092673招募中1 期

A Phase 1-2 Dose-Escalation and Cohort-Expansion Study of Intravenous Zotatifin (eFT226) in Subjects With Selected Advanced Solid Tumor Malignancies

Effector Therapeutics14 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年10月25日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
招募中
入组人数
30
试验地点
14
主要终点
Part 2: (Combination Cohorts) Determine MTD
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This clinical trial is a Phase 1-2, open-label, sequential-group, dose-escalation and cohort-expansion study evaluating the safety, pharmacokinetics (PK), pharmacodynamics, and antitumor activity of Zotatifin (eFT226) in subjects with selected advanced solid tumor malignancies.

详细描述

Part 1 (Dose Escalation): Completed; Recommended Phase 2 Dose (RP2D) and Maximum Tolerated Dose (MTD) identified

Part 1a (Dose Escalation) This cohort will enroll patients with an advanced breast cancer that is refractory or intolerant to SOC therapy.

Part 1b (Dose Escalation) This cohort will enroll patients with an advanced breast cancer that is refractory or intolerant to SOC therapy.

Part 2 (Expansion Cohort) provides defined expansion cohorts to further explore the safety, pharmacology, and clinical activity of eFT226 monotherapy and in various combinations in subjects with previously treated advanced solid tumor malignancies.

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

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Part 1: Sequential escalation (Completed)

Experimental

eFT226 administered IV weekly in 21-day cycles; dose escalated in sequential cohorts after subjects enrolled in a given cohort have completed DLT evaluation period.

干预措施: eFT226 (Drug)

Part 2: Cohort Expansion, Combination, NSCLC, Sotorasib (ECNS)

Experimental

Cohort ECNS; Combination therapy partner administered per SOC at the approved dose.

干预措施: Sotorasib (Drug)

Part 2: Cohort Expansion, Monotherapy, NSCLC, KRAS (EMNK)

Experimental

Cohort EMNK

干预措施: eFT226 (Drug)

Part 2: Cohort Expansion, Monotherapy, Breast, FGFR (EMBF)

Experimental

Cohort EMBF

干预措施: eFT226 (Drug)

Part 2: Cohort Expansion, Monotherapy, Breast, HER2 (EMBH)

Experimental

Cohort EMBH

干预措施: eFT226 (Drug)

Part 1b Dose Escalation, Combination, Breast

Experimental

eFT226 administered IV every other week in 14-day cycles. Fulvestrant will also be given. Dose escalations per protocol.

干预措施: Fulvestrant (Drug)

Part 2: Cohort Expansion, Combination, Breast, Fulvestrant (ECBF)

Experimental

Cohort ECBF; Combination therapy partner administered per SOC at the approved dose.

干预措施: Fulvestrant (Drug)

Part 2 Cohort Expansion, Combination, Breast, Fulvestrant, Cyclin D1

Experimental

ECBF-D1; Combination therapy partner administered per SOC at the approved dose.

干预措施: Fulvestrant (Drug)

Part 2: Cohort Expansion, Combination, Breast, Fulvestrant+Abemaciclib (ECBF+A)

Experimental

Cohort ECBF+A; Combination therapy partner administered per SOC at the approved dose.

干预措施: Fulvestrant (Drug)

Part 2: Cohort Expansion, Combination, Breast, Fulvestrant+Abemaciclib (ECBF+A)

Experimental

Cohort ECBF+A; Combination therapy partner administered per SOC at the approved dose.

干预措施: Abemaciclib (Drug)

Part 2: Cohort Expansion, Combination, Breast, Trastuzumab (ECBT)

Experimental

Cohort ECBT; Combination therapy partner administered per SOC at the approved dose.

干预措施: Trastuzumab (Drug)

Part 1a: Dose Escalation, Combination, Breast

Experimental

eFT226 administered IV weekly in 21-day cycles. Fulvestrant will also be given. Dose escalations per protocol.

干预措施: Fulvestrant (Drug)

结局指标

主要结局

Part 2: (Combination Cohorts) Determine MTD

时间窗: Through study completion, approximately 12 months

determined by occurrence of first cycle Dose Limiting Toxicities (DLTs) within the study design

Part 2: Percent change in tumor dimensions of target lesions- Efficacy

时间窗: Through study completion, approximately 12 months

calculated by the percentage change from baseline in the sum of the LD of target lesions

Parts 1a and 1b; incidence of AEs, serious adverse events (SAEs), and DLTs

时间窗: Through study completion, approximately 12 months

according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)

Parts 1a and 1b: MTD

时间窗: Through study completion, approximately 12 months

determined by occurrence of first cycle DLTs within a 3+3 or 3+3+3 clinical trial design

Parts 1a and 1b: RP2D

时间窗: Through study completion, approximately 12 months

determine by Incidence, type, and severity of AEs and SAEs graded as per NCI CTCAE

Part 2: Objective Response Rate- Efficacy

时间窗: Through study completion, approximately 12 months

defined as confirmed Complete Response (CR) or Partial Response (PR)

Part 2: (Combination Cohorts) Incidence, type, and severity of AEs and SAEs

时间窗: Through study completion, approximately 12 months

via adverse event monitoring

Part 2: (Combination Cohorts) Determine RP2D

时间窗: Through study completion, approximately 12 months

determined by incidence and type of DLTs, and incidence, type, and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)

Part 2: Time to Response (TTR)- Efficacy

时间窗: Through study completion, approximately 12 months

defined as the interval from the start of study therapy to the first documentation of an objective response

Part 2: Duration of Response (DOR)- Efficacy

时间窗: Through study completion, approximately 12 months

defined as the interval from the first documentation of objective response to the earlier of the first documentation of disease progression or death from any cause

次要结局

  • Parts 1a and 1b: Objective response(Through study completion, approximately 12 months)
  • Part 2: (Monotherapy and Combination Cohorts) Incidence and severity of AEs, SAEs, and additional safety parameters(Through study completion, approximately 12 months)
  • Parts 1a and 1b: Percent change in tumor dimensions of target lesions(Through study completion, approximately 12 months)
  • Parts 1a and 1b: DOR(Through study completion, approximately 12 months)
  • Parts 1a and 1b: PFS(Through study completion, approximately 12 months)
  • Evaluate plasma Pharmacokinetic (PK) parameters of eFT226including terminal state volume of distribution(Through study completion, approximately 12 months)
  • Evaluate plasma Pharmacokinetic (PK) parameters of eFT226 including terminal phase rate constant(Through study completion, approximately 12 months)
  • Parts 1a and 1b: TTR(Through study completion, approximately 12 months)
  • Evaluate plasma Pharmacokinetic (PK) parameters of eFT226(Through study completion, approximately 12 months)
  • Part 2: Progression Free Survival(Through study completion, approximately 12 months)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (14)

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