NCT06005740招募中1 期
A Phase 1, First in Human Study of TORL-4-500 in Patients with Advanced 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
- 70
- 试验地点
- 10
- 主要终点
- Maximum Tolerated Dose (MTD)
研究概览
简要总结
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-4-500 in patients with advanced cancer.
For Part 1, any advanced or metastatic solid tumor malignancy will be evaluated including, for example, adrenocortical carcinoma (ACC).
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
- •Advanced solid tumor
- •Measurable disease, per RECIST v1.1
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •Adequate organ function
排除标准
- •Has not recovered [recovery is defined as NCI CTCAE, version 5.0, grade ≤1] from the acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements
- •Received prior chemotherapeutic, investigational, or other therapies for the treatment of cancer within 14 days with small molecule and within 28 days with biologic before the first dose of TORL-4-500
- •Progressive or symptomatic brain metastases
- •Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection
- •History of significant cardiac disease
- •History of myelodysplastic syndrome (MDS) or AML
- •History of another cancer within 3 years before Day 1 of study treatment, with the exception of basal or squamous cell carcinoma of the skin that has been definitively treated. A history of other malignancies with a low risk of recurrence, including appropriately treated ductal carcinoma in situ (DCIS) of the breast and prostate cancer with a Gleason score less than or equal to 6, are also not excluded
- •If female, is pregnant or breastfeeding
研究组 & 干预措施
Monotherapy Dose Dose Finding - Part 1
Experimental
TORL-4-500 iv once every 3 weeks
干预措施: TORL-4-500 (Drug)
Expansion as Monotherapy - Part 2
Experimental
TORL-4-500 iv once every 3 weeks
干预措施: TORL-4-500 (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD)
时间窗: 28 Days
Highest administered dose with \< 33% participants experiencing dose limiting toxicity (DLT) in the first 6 DLT evaluable participants
Recommended Phase 2 Dose (RP2D)
时间窗: up to 2 years
Based on the maximum tolerated dose, cumulative safety, and pharmacokinetic data
Incidence and severity of adverse events and serious adverse events
时间窗: up to 2 years
Incidence and severity of adverse events, serious adverse events, according to NCI-CTCAE Version 5.0
次要结局
- Objective Response Rate (ORR)(up to 2 years)
- Duration of Response (DOR)(up to 2 years)
- Progression Free Survival (PFS)(up to 2 years)
- Time to Response (TTR)(up to 2 years)
- 1 Year Overall Survival (1YOS)(1 year)
- 2 Year Overall Survival (2YOS)(2 years)
- Number of anti-drug antibody (ADA) Positive Participants(up to 2 years)
- Maximum Serum Concentration of TORL-4-500 (Cmax)(21 days)
- Minimum Serum Concentration of TORL-4-500 (Cmin)(21 days)
- Maximum Serum Concentration of TORL-4-500 at Steady State (Cmax,ss)(63 days)
- Minimum Serum Concentration of TORL-4-500 at Steady State (Cmin,ss)(63 days)
- Time of Maximum Serum Concentration of TORL-4-500 (Tmax)(21 days)
- Time of Minimum Serum Concentration of TORL-4-500 (Tmin)(21 days)
- Time of Minimum Serum Concentration of TORL-4-500 at Steady State (Tmin,ss)(63 days)
- Terminal Half-life (t1/2) of Serum TORL-4-500-ADC(63 days)
- Area under the Serum Concentration-Time curve from the time of dosing to the last measurable concentration (AUClast) for TORL-4-500(21 days)
- Area under the Serum Concentration-Time curve from the time of dosing extrapolated to time infinity (AUCinf) for TORL-4-500(63 days)
- Apparent volume of distribution during the terminal phase (Vz) of TORL-4-500(63 days)
- Clearance (CL) of TORL-4-500(63 days)
- Accumulation ratio (Rac) of TORL-4-500(63 days)
研究者
研究点 (10)
Loading locations...
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