ACR-2316-101: Phase 1/2 Study of ACR-2316 in Subjects With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 15
- 主要终点
- Dose Expansion
研究概览
简要总结
This is a first in-human, Open-label Phase 1/2 study to assess the safety and activity of ACR-2316 for the treatment of subjects with specific, histologically confirmed, locally advanced, recurrent or metastatic solid tumors.
详细描述
The Phase 1/2 monotherapy clinical trial for ACR-2316 is designed to assess the safety, tolerability and preliminary evaluation of anti-tumor activity of ACR-2316. Additional objectives include the determination of the maximal tolerated dose and recommended Phase 2 monotherapy dose, characterization of the pharmacokinetic profile and pharmacogenomics.
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
- •Signed written informed consent.
- •Histologically or cytologically proven metastatic, recurrent or locally advanced selected solid tumors.
- •Must be willing to provide redacted pathology report and next-generation sequencing (NGS) reports.
- •Subjects should have received no more than 3 lines of systemic therapy for recurrent disease.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at trial entry and an estimated life expectancy of at least 3 months.
- •Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST v1.
- •Adequate organ functions.
- •Must have progressed after prior line of treatment.
排除标准
- •(all participants):
- •Participants with known symptomatic brain metastases.
- •Participant had systemic therapy within 3 weeks prior to the first dose of study drug.
- •Participant had radiation therapy for curative intent within 4 weeks prior to the first dose of study drug.
- •Participant had palliative radiation therapy within 2 weeks prior to the first dose of study drug.
- •Women who are pregnant or lactating.
研究组 & 干预措施
Dose escalation
ACR-2316 will be administered using a 3-week or a 4-week schedule.
干预措施: ACR-2316 (Drug)
Dose expansion
ACR-2316 will be administered using a 3-week schedule.
干预措施: ACR-2316 (Drug)
结局指标
主要结局
Dose Expansion
时间窗: Confirmed ORR per Recist v1.1 and DOR, CBR, assessed every 6 weeks from baseline thorough study completion, an average 1 year or until death.
To determine preliminary anti-tumor activity of ACR-2316.
Dose Expansion
时间窗: RP2D supported by safety, PK and PD data through study completion
To determine the RP2D of ACR-2316, safety and preliminary evaluation of anti-tumor activity
Dose Expansion
时间窗: Incidence and grades of TEAEs and TRAEs per NCI CTCAE v.5.0 and number of dose decreases, number of dose delays, and SAEs through study completion, an average of 1 year.
To assess the safety and tolerability of ACR-2316
Dose Escalation
时间窗: Number of DLT events during the DLT observation period (up to 28 days)
To determine the MTD of ACR-2316.
Dose Expansion
时间窗: Confirmed ORR per Recist v1.1 and DOR, CBR, assessed every 6 weeks from baseline thorough study completion, an average 1 year or until death.
To determine preliminary anti-tumor activity of ACR-2316.
次要结局
- Dose Expansion(Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.)
- Dose Escalation(Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.)
- Dose Escalation(This will be evaluated through study completion)
- Dose Escalation(Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.)
- Dose Expansion(Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.)