NCT05304962招募中1 期
First-in-Human, Escalating Oral Dose Study of RGT-419B Given Alone and With Endocrine Therapy in Subjects With Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Advanced/Metastatic 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
- 64
- 试验地点
- 8
- 主要终点
- Safety & Tolerability - Number of subjects with Dose-Limiting Toxicities (DLTs) at each cohort dose level in singlet and doublet therapy
研究概览
简要总结
This is a phase I, First-in-Human (FIH), open-label study to evaluate the safety, tolerability, pharmacokinetic (PK) profile, and preliminary efficacy of RGT-419B administered orally as monotherapy OR in combination with Hormonal Therapy in subjects with HR+, HER2- locally advanced and unresectable (Stage III) or metastatic (Stage IV) breast cancer whose disease has progressed during prior therapy with an approved CDK4/6i plus hormonal therapy.
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
- •Male or female >/= 18 years old
- •ECOG Performance Status 0 to 1
- •Subjects must have histologically or cytologically confirmed diagnosis of ER+, HER2- ABC consistent with ASCO CAP guidelines that is locally advanced and unresectable (Stage III) or metastatic (Stage IV) BC.
- •Measurable AND evaluable lesions at baseline per RECIST v1.
- •Eligible subjects must meet all of the following criteria:
- •Progression after receiving 1 line of prior cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) therapy combined with HT in the MBC setting (up to 1 additional line of CDK4/6i is permitted in the post-surgical adjuvant setting);
- •Subjects must have received therapy for ≥3 months in the MBC setting, or for ≥6 months in the adjuvant setting, prior to progression
- •Progression after ≤3 lines of prior HT therapy (regardless of whether it is HT alone or in combination with other therapies)
- •Prior HT combination agents, including SERD, SERM or AI, must have received formal approval by regulatory agency.
- •≤ 1 prior line of chemotherapy in the metastatic setting
- •Adequate organ function
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Presence of visceral metastases with severe organ dysfunction as evidence by signs and symptoms, laboratory studies, lymphangitic spread and/or rapid progression of disease
- •Pregnant or planning to become pregnant
- •Prior irradiation to >25% of the bone marrow and/or inadequate bone marrow function or evidence of clinically significant end-organ damage
- •Major surgery, chemotherapy, targeted therapy, experimental agents, or radiation within 14-28 days prior to Cycle 1, Day 1
- •Active, serious medical condition that is not well controlled with locally approved medications allowed by the protocol
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to the drugs used in the study
研究组 & 干预措施
Arm B
Experimental
RGT-419B in combination with Hormonal Therapy
干预措施: RGT-419B in combination with hormonal therapy (Drug)
Arm A
Experimental
RGT-419B given alone as monotherapy
干预措施: RGT-419B (Drug)
结局指标
主要结局
Safety & Tolerability - Number of subjects with Dose-Limiting Toxicities (DLTs) at each cohort dose level in singlet and doublet therapy
时间窗: 4 weeks (1 cycle)
Number of subjects who have a confirmed DLT at each cohort dose level in singlet and doublet study arms during the first 28-day cycle of RGT-419B treatment.
次要结局
- Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Area Under Concentration-Time Curve to Infinity (AUC0-inf)(through study completion, an average of 1 year)
- Safety & Tolerability - Incidence, Severity, and Causality of all Treatment Emergent Adverse Events (TEAEs)(through study completion, an average of 1 year)
- Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Cmax(through study completion, an average of 1 year)
- Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Area Under Concentration-Time Curve (AUC0-t)(through study completion, an average of 1 year)
- Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Plasma Decay Half-Life (t 1/2)(through study completion, an average of 1 year)
- Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Time to Reach Maximum Observed Plasma Concentration (Tmax)(through study completion, an average of 1 year)
- Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Cumulative urinary excretion(through study completion, an average of 1 year)
- Tumor Response assessed by Investigator according to RECIST v1.1(through study completion, an average of 1 year)
- Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Accumulation rate after multiple doses(through study completion, an average of 1 year)
- QTc Interval - Changes in corrected QT interval(through study completion, an average of 1 year)
研究者
研究点 (8)
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