NCT07819136招募中1 期
A Phase 1 / 2, Open-Label Study of REC-7735 in Participants With Unresectable, Locally Advanced, or Metastatic PIK3CA-H1047R Mutated Solid Tumors
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
- 90
- 试验地点
- 6
- 主要终点
- Phase 1A: Number of Participants With Dose-limiting Toxicities (DLTs)
研究概览
简要总结
The study is designed to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of REC-7735 in participants with unresectable, locally advanced, or metastatic PIK3CA-H1047R mutated solid tumors.
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
- •Participants have histologically-confirmed unresectable, locally advanced, or metastatic solid tumors which exhibit the PIK3CA H1047R mutation in tumor tissue and/or blood (circulating tumor deoxyribonucleic acid [ctDNA]).
- •For Phase 1A and planned monotherapy cohorts in Phase 1B, participants have experienced progressive disease, relapsed disease, or be intolerant to at least one established standard systemic anti-cancer treatment for a given tumor type, or in the opinion of the Investigator have been considered ineligible for standard therapy.
- •All toxicities from prior anti-cancer therapies have resolved to ≤ Grade 1 or the participant's previous baseline, with the exception of alopecia and peripheral neuropathy.
排除标准
- •Participants have experienced disease progression with a phosphoinositide 3-kinase (PI3Ka), protein kinase B (AKT) or mechanistic target of rapamycin (mTOR) inhibitor unless deemed suitable for REC-7735 treatment at the discretion of the Investigator and following discussion with the Sponsor.
- •Known loss-of-function mutations in phosphatase and tensin homolog (PTEN), PTEN loss, or activating mutations in AKT, unless deemed suitable for REC-7735 treatment at the discretion of the Investigator and following discussion with the Sponsor.
- •Major surgery within 6 weeks from treatment initiation.
- •Any serious underlying medical or psychiatric condition that would preclude understanding and rendering of informed consent or impair the ability of the participant to receive or tolerate the planned treatment.
- •Recent or ongoing serious infection.
- •Recent prior systemic anti-cancer treatment.
- •Known clinically significant UGT1A1 deficiency, including Gilbert's syndrome (for example, documented homozygous UGT1A1*28)
- •Has an established diagnosis of uncontrolled diabetes mellitus defined as meeting any one of the following:
- •NOTE: This criterion is not applicable to those participants enrolling in the Phase 1B Dose Expansion cohort designated for hyperglycemia vulnerable participants
- •Glycated hemoglobin (HbA1c) ≥8%
- •Currently requiring insulin
- •Fasting blood glucose (FBG) ≥140 milligrams (mg)/deciliter (dL) (7.8 millimoles [mmol]/liter [L]) in the past 30 days prior to dosing
- •NOTE: Two FBG samples must be drawn at least seven days apart from each other.
- •Note: Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Phase 1A Dose Finding: REC-7735
Experimental
Participants will receive REC-7735 twice daily (BID).
干预措施: REC-7735 (Drug)
Phase 1B Dose Expansion/Optimization: REC-7735
Experimental
Participants will receive REC-7735 BID.
干预措施: REC-7735 (Drug)
结局指标
主要结局
Phase 1A: Number of Participants With Dose-limiting Toxicities (DLTs)
时间窗: 28 days
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
时间窗: Up to 2 years
Phase 1B: Objective Response Rate (ORR) According to Standard Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
时间窗: Up to 2 years
次要结局
- Maximum (Peak) Drug Concentration (Cmax) of REC-7735(Up to 2 years)
- Time to Reach Cmax following drug administration (Tmax) of REC-7735(Up to 2 years)
- Area Under the Concentration-time Curve During a Dosing Interval (AUCtau) of REC-7735(Up to 2 years)
- Phase 1A: ORR According to Standard RECIST 1.1(Up to 2 years)
- Phase 1B: Clinical Benefit Rate (CBR) According to Standard RECIST 1.1(Up to 2 years)
- Phase 1B: Duration of Response (DOR) According to Standard RECIST 1.1(Up to 2 years)
- Phase 1B: Duration of Stable Disease (SD) According to Standard RECIST 1.1(Up to 2 years)
- Phase 1B: Time to Response (TTR) According to Standard RECIST 1.1(Up to 2 years)
- Phase 1B: Progression-free Survival (PFS) According to Standard RECIST 1.1(Up to 2 years)
- Phase 1B: Overall Survival(Up to 2 years)
研究者
研究点 (6)
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