NCT06638307招募中1 期
A Phase 1, First-in-Human Study of MEN2312, a KAT6 Inhibitor, as Monotherapy and in Combination in Participants With Advanced Breast Cancer
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
- 240
- 试验地点
- 64
- 主要终点
- Number of Participants Experiencing Dose-limiting Toxicity When Administered MEN2312
研究概览
简要总结
This is a first-in-human study of MEN2312, a lysine acetyltransferase 6 (KAT6) inhibitor, in adult participants with advanced breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Participant has advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy.
- •Presence of genetic alterations in PIK3CA/AKT1/PTEN in participants' tumor tissue.
- •Participant must have received at least 1 prior line of endocrine therapy for advanced/metastatic disease or participant who has radiological evidence of breast cancer recurrence or progression during or within 12 months from the end of adjuvant treatment with endocrine therapy, as these participants are considered as first-line relapsed participants.
- •Progression on previous cyclin-dependent kinase 4 and 6 inhibitor treatment in combination with fulvestrant or aromatase inhibitor is required.
排除标准
- •Active or newly diagnosed central nervous system metastases.
- •Participants with advanced, symptomatic visceral spread, who are at risk of life-threatening complications in the short term, including massive uncontrolled effusions (peritoneal, pleural, pericardial), pulmonary lymphangitis, or liver involvement >50%.
- •Participants with any toxicities related to prior radiation therapy that have not resolved to baseline or to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 Grade ≤1, except alopecia and peripheral sensory neuropathy (Grade ≤2).
- •Note: Other inclusion/exclusion criteria may apply.
研究组 & 干预措施
MEN2312: Combination Therapy (Elacestrant)
Experimental
Participants will receive MEN2312 in combination with elacestrant.
干预措施: Elacestrant (Drug)
MEN2312: Combination Therapy (Elacestrant)
Experimental
Participants will receive MEN2312 in combination with elacestrant.
干预措施: MEN2312 (Drug)
MEN2312: Monotherapy
Experimental
Participants will receive MEN2312.
干预措施: MEN2312 (Drug)
结局指标
主要结局
Number of Participants Experiencing Dose-limiting Toxicity When Administered MEN2312
时间窗: Baseline through Day 28
Recommended Phase 2 Dose (RP2D) of MEN2312
时间窗: Baseline through Month 6
次要结局
- Overall Response Rate (ORR)(Baseline through 28 days after the last treatment administration (up to approximately 7 months))
- Duration of Response (DOR)(Baseline through 28 days after the last treatment administration (up to approximately 7 months))
- Clinical Benefit Rate (CBR)(Baseline through 28 days after the last treatment administration (up to approximately 7 months))
- Progression-free Survival (PFS)(Baseline through 28 days after the last treatment administration (up to approximately 7 months))
- Overall Survival (OS)(Baseline through 3 months after the last treatment administration (up to approximately 9 months))
- Time to Response (TTR)(Baseline through 28 days after the last treatment administration (up to approximately 7 months))
- Area Under the Plasma Concentration-time Curve (AUC) of MEN2312 When Administered as Monotherapy(Up to 6 months post dose)
- AUC of MEN2312 When Administered as Combination Therapy(Up to 6 months post dose)
- Amount of MEN2312 Excreted in Urine When Administered as Monotherapy(Up to 2 months post dose)
- Comparison of Plasma Concentration of MEN2312 Monotherapy With MEN2312 Combination Therapy(Up to 6 months post dose)
- Overall Response Rate (ORR)(Baseline through 28 days after the last treatment administration (up to approximately 7 months))
- Clinical Benefit Rate (CBR)(Baseline through 28 days after the last treatment administration (up to approximately 7 months))
- Progression-free Survival (PFS)(Baseline through 28 days after the last treatment administration (up to approximately 7 months))
- Overall Survival (OS)(Baseline through 3 months after the last treatment administration (up to approximately 9 months))
- Time to Response (TTR)(Baseline through 28 days after the last treatment administration (up to approximately 7 months))
- Area Under the Plasma Concentration-time Curve (AUC) of MEN2312 When Administered as Monotherapy(Up to 6 months post dose)
- AUC of MEN2312 When Administered as Combination Therapy(Up to 6 months post dose)
- Amount of MEN2312 Excreted in Urine When Administered as Monotherapy(Up to 2 months post dose)
- Comparison of Plasma Concentration of MEN2312 Monotherapy With MEN2312 Combination Therapy(Up to 6 months post dose)
研究者
研究点 (64)
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